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Study flow diagram 2015 update
Figuras y tablas -
Figure 1

Study flow diagram 2015 update

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'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 1 Incidence of herpes zoster.
Figuras y tablas -
Analysis 1.1

Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 1 Incidence of herpes zoster.

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Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 2 Incidence of herpes zoster with ZBPI ADL. Severity of interference scores of 300 or greater (high score is worse).
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Analysis 1.2

Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 2 Incidence of herpes zoster with ZBPI ADL. Severity of interference scores of 300 or greater (high score is worse).

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Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 3 Participants with AEs.
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Analysis 1.3

Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 3 Participants with AEs.

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Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 4 Drop‐outs.
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Analysis 1.4

Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 4 Drop‐outs.

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Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 5 Participants with no follow‐up.
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Analysis 1.5

Comparison 1 Available live attenuated VZV zoster vaccine versus placebo, Outcome 5 Participants with no follow‐up.

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Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 1 Incidence of herpes zoster.
Figuras y tablas -
Analysis 2.1

Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 1 Incidence of herpes zoster.

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Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 2 Vaccine‐related adverse effects.
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Analysis 2.2

Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 2 Vaccine‐related adverse effects.

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Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 3 Vaccine‐related systemic adverse effects.
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Analysis 2.3

Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 3 Vaccine‐related systemic adverse effects.

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Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 4 Vaccine‐related serious adverse effects.
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Analysis 2.4

Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 4 Vaccine‐related serious adverse effects.

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Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 5 Injection site vaccine‐related adverse effects.
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Analysis 2.5

Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 5 Injection site vaccine‐related adverse effects.

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Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 6 Participants with no follow‐up.
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Analysis 2.6

Comparison 2 Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine, Outcome 6 Participants with no follow‐up.

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Comparison 3 Live attenuated VZV zoster vaccine zoster vaccine refrigerated versus zoster vaccine frozen, Outcome 1 Participants with adverse effects.
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Analysis 3.1

Comparison 3 Live attenuated VZV zoster vaccine zoster vaccine refrigerated versus zoster vaccine frozen, Outcome 1 Participants with adverse effects.

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Comparison 3 Live attenuated VZV zoster vaccine zoster vaccine refrigerated versus zoster vaccine frozen, Outcome 2 Participants with no follow‐up.
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Analysis 3.2

Comparison 3 Live attenuated VZV zoster vaccine zoster vaccine refrigerated versus zoster vaccine frozen, Outcome 2 Participants with no follow‐up.

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Comparison 4 Live attenuated VZV zoster vaccine versus inactivated zoster vaccine, Outcome 1 Incidence of herpes zoster.
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Analysis 4.1

Comparison 4 Live attenuated VZV zoster vaccine versus inactivated zoster vaccine, Outcome 1 Incidence of herpes zoster.

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Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 1 3200 pfu VZV/dose.
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Analysis 5.1

Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 1 3200 pfu VZV/dose.

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Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 2 8500 pfu VZV/dose.
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Analysis 5.2

Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 2 8500 pfu VZV/dose.

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Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 3 41,650 pfu/dose.
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Analysis 5.3

Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 3 41,650 pfu/dose.

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Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 4 Duration in days of adverse effects.
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Analysis 5.4

Comparison 5 Live attenuated VZV zoster vaccine versus pneumo 23 vaccine, Outcome 4 Duration in days of adverse effects.

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Comparison 6 Live attenuated VZV zoster vaccine IM route versus zoster vaccine SC route, Outcome 1 Participants with adverse events.
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Analysis 6.1

Comparison 6 Live attenuated VZV zoster vaccine IM route versus zoster vaccine SC route, Outcome 1 Participants with adverse events.

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Comparison 7 Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals, Outcome 1 Zoster vaccine 1 month schedule versus zoster vaccine 3 month schedule.
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Analysis 7.1

Comparison 7 Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals, Outcome 1 Zoster vaccine 1 month schedule versus zoster vaccine 3 month schedule.

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Comparison 7 Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals, Outcome 2 Zoster vaccine 1 month schedule versus zoster vaccine single dose.
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Analysis 7.2

Comparison 7 Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals, Outcome 2 Zoster vaccine 1 month schedule versus zoster vaccine single dose.

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Comparison 7 Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals, Outcome 3 Zoster vaccine 3 month schedule versus zoster vaccine single dose.
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Analysis 7.3

Comparison 7 Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals, Outcome 3 Zoster vaccine 3 month schedule versus zoster vaccine single dose.

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Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 1 50 μg gE/AS01E versus 50 μg gE/AS01B.
Figuras y tablas -
Analysis 8.1

Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 1 50 μg gE/AS01E versus 50 μg gE/AS01B.

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Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 2 50 μg gE/AS01E versus 50 μg gE/saline (unadjuvanted gE).
Figuras y tablas -
Analysis 8.2

Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 2 50 μg gE/AS01E versus 50 μg gE/saline (unadjuvanted gE).

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Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 3 50 μg gE/AS01B versus 50 μg gE/saline (unadjuvanted gE).
Figuras y tablas -
Analysis 8.3

Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 3 50 μg gE/AS01B versus 50 μg gE/saline (unadjuvanted gE).

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Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 4 50 μg gE/AS01E versus saline.
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Analysis 8.4

Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 4 50 μg gE/AS01E versus saline.

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Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 5 50 μg gE/AS01B versus saline.
Figuras y tablas -
Analysis 8.5

Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 5 50 μg gE/AS01B versus saline.

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Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 6 50 μg gE/Saline (unadjuvanted) versus saline.
Figuras y tablas -
Analysis 8.6

Comparison 8 Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline, Outcome 6 50 μg gE/Saline (unadjuvanted) versus saline.

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 1 25 µg gE/AS01B versus 50 µg gE/AS01B.
Figuras y tablas -
Analysis 9.1

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 1 25 µg gE/AS01B versus 50 µg gE/AS01B.

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 2 25 µg gE/AS01B versus 100 µg gE/AS01B.
Figuras y tablas -
Analysis 9.2

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 2 25 µg gE/AS01B versus 100 µg gE/AS01B.

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 3 50 µg gE/AS01B versus 100 µg gE/AS01B.
Figuras y tablas -
Analysis 9.3

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 3 50 µg gE/AS01B versus 100 µg gE/AS01B.

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 4 25 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE).
Figuras y tablas -
Analysis 9.4

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 4 25 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE).

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 5 50 µg gE/AS01B a versus 100 µg gE/saline (unadjuvanted gE).
Figuras y tablas -
Analysis 9.5

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 5 50 µg gE/AS01B a versus 100 µg gE/saline (unadjuvanted gE).

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 6 100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE).
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Analysis 9.6

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 6 100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE).

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 7 25 µg gE/AS01B versus saline + 100 µg gE/AS01B.
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Analysis 9.7

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 7 25 µg gE/AS01B versus saline + 100 µg gE/AS01B.

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 8 50 µg gE/AS01B versus saline + 100 µg gE/AS01B.
Figuras y tablas -
Analysis 9.8

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 8 50 µg gE/AS01B versus saline + 100 µg gE/AS01B.

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 9 100 µg gE/AS01B versus saline + 100 µg gE/AS01B.
Figuras y tablas -
Analysis 9.9

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 9 100 µg gE/AS01B versus saline + 100 µg gE/AS01B.

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Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 10 Saline + 100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE).
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Analysis 9.10

Comparison 9 Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline, Outcome 10 Saline + 100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE).

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Comparison 10 Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo, Outcome 1 Incidence of herpes zoster 3.2 years follow‐up (≥ 60 yo).
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Analysis 10.1

Comparison 10 Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo, Outcome 1 Incidence of herpes zoster 3.2 years follow‐up (≥ 60 yo).

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Comparison 10 Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo, Outcome 2 Participants with AEs.
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Analysis 10.2

Comparison 10 Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo, Outcome 2 Participants with AEs.

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Comparison 10 Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo, Outcome 3 Drop‐outs.
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Analysis 10.3

Comparison 10 Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo, Outcome 3 Drop‐outs.

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Summary of findings for the main comparison. Available live attenuated VZV zoster vaccine versus placebo for preventing herpes zoster in older adults

Available live attenuated VZV zoster vaccine versus placebo for preventing herpes zoster in older adults

Patient or population: healthy older adults

Settings: outpatients

Intervention: available live attenuated VZV zoster vaccine

Comparison: placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Available live attenuated VZV zoster vaccine

Incidence of herpes zoster

Clinical and laboratory criteria
Follow‐up: median 3.1 years

Study population

RR 0.49
(0.43 to 0.56)

38,546
(1 study)

⊕⊕⊕⊝
moderate1

Absolute risk for available live attenuated VZV zoster vaccine = 1.6%

Absolute risk for placebo group = 3.3%

33 per 1000

16 per 1000
(14 to 19)

Participants with AEs: ≥ 1 serious AE regardless of type of storage of the vaccine

Clinical and laboratory criteria
Follow‐up: median 3.1 years

Study population

RR 1.08
(0.96 to 1.2)

50,896
(4 studies)

⊕⊕⊕⊝
moderate1

Absolute risk for available live attenuated VZV zoster vaccine = 2.3%

Absolute risk for placebo group = 2.2%

22 per 1000

23 per 1000
(21 to 26)

Participants with AEs: hospitalised

Number of participants hospitalised
Follow‐up: median 3.1 years

Study population

RR 1.00
(0.93 to 1.07)

6616
(1 study)

⊕⊕⊕⊝
moderate1

Absolute risk for available live attenuated VZV zoster vaccine = 34.1%

Absolute risk for placebo group = 34.1%

341 per 1000

341 per 1000
(317 to 365)

Participants with AEs: injection site AEs

Clinical and laboratory criteria
Follow‐up: median 3.1 years

Study population

RR 2.99 (2.75 to 3.26)

6986
(3 studies)

⊕⊕⊕⊝
moderate1

Absolute risk for available live attenuated VZV zoster vaccine = 47.9%

Absolute risk for placebo group = 16.0%

160 per 1000

479 per 1000
(440 to 521)

Drop‐outs: death

Number of deaths
Follow‐up: median 3.1 years

Study population

RR 1.01
(0.92 to 1.11)

50,687
(3 studies)

⊕⊕⊕⊝
moderate1

Absolute risk for available live attenuated VZV zoster vaccine = 3.3%

Absolute risk for placebo group = 3.2%

32 per 1000

33 per 1000
(30 to 36)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
AE: adverse event; CI: confidence interval; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Did not describe random sequence generation.

Figuras y tablas -
Summary of findings for the main comparison. Available live attenuated VZV zoster vaccine versus placebo for preventing herpes zoster in older adults
Ir a la tabla de la revisión
Summary of findings 2. Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo for preventing herpes zoster in older adults

Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo for preventing herpes zoster in older adults

Patient or population: healthy older adults
Settings: outpatients
Intervention: adjuvanted recombinant VZV subunit zoster vaccine (not yet available)

Comparison: placebo

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo

Incidence of herpes zoster 3.2 years follow‐up (≥ 60 yo)

Clinical and laboratory criteria
Follow‐up: mean 3.2 years

Study population

RR 0.04 (0.02 to 0.1)

8122
(1 study)

⊕⊕⊕⊝
moderate1

Absolute risk for adjuvanted recombinant VZV subunit zoster vaccine (not yet available) = 0.2%

Absolute risk for placebo group = 3.4%

34 per 1000

2 per 1000
(1 to 3)

Participants with AEs: any local symptom

Clinical criteria
Follow‐up: mean 3.2 years

Study population

RR 6.83 (6.30 to 7.42)

8759
(1 study)

⊕⊕⊕⊝
moderate1

Absolute risk for adjuvanted recombinant VZV subunit zoster vaccine (not yet available) = 81.5%

Absolute risk for placebo group = 11.9%

119 per 1000

815 per 1000
(751 to 885)

Participants with AEs: serious AEs

Clinical and laboratory criteria
Follow‐up: mean 3.2 years

Study population

RR 1.01 (0.91 to 1.1)

15,411
(1 study)

⊕⊕⊕⊝
moderate1

Absolute risk for adjuvanted recombinant VZV subunit zoster vaccine (not yet available) = 9.0%

Absolute risk for placebo group = 8.9%

89 per 1000

90 per 1000
(81 to 99)

Participants with AEs: potential immune‐mediated disease

Clinical and laboratory criteria
Follow‐up: mean 3.2 years

Study population

RR 0.81 (0.06 to 1.08)

15,411
(1 study)

⊕⊕⊕⊝
moderate1

Absolute risk for adjuvanted recombinant VZV subunit zoster vaccine (not yet available) = 1.0%

Absolute risk for placebo group = 1.3%

13 per 1000

10 per 1000
(1 to 14)

Participants with AEs: deaths

Number of deaths

Follow‐up: mean 3.2 years

Study population

RR 0.96 (0.78 to 1.19)

15,411
(1 study)

⊕⊕⊕⊝
moderate1

Absolute risk for adjuvanted recombinant VZV subunit zoster vaccine (not yet available) = 2.2%

Absolute risk for placebo group = 2.3%

23 per 1000

22 per 1000
(18 to 27)

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
AE: adverse event; CI: confidence interval; RR: risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1Did not describe allocation concealment and participant flow not clear.

Figuras y tablas -
Summary of findings 2. Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo for preventing herpes zoster in older adults
Ir a la tabla de la revisión
Table 1. Comprehensive risk of bias

Domain

Risk of bias

Allocation (selection bias): randomisation criteria

We graded 5 studies as having a low risk of bias for random sequence generation (selection bias) because they described how the randomisation was done (Chlibek 2013; Diez‐Domingo 2015; Lal 2015; Vermeulen 2012; Vesikari 2013). Chlibek 2013 stated that "Randomization was made using an algorithm that stratified by country, minimized for age, and included a block size of 11". In Diez‐Domingo 2015: "The subjects were randomised using an electronic case report form (e‐CRF)". Lal 2015 stated that "We randomly assigned participants in a 1:1 ratio to receive either vaccine or placebo using an online centralized randomization system". Vermeulen 2012 stated that "Subjects were randomised in a 1:1 ratio to receive two doses of either zoster vaccine or placebo, according to a computer‐generated, study‐centre specific allocation schedule". Vesikari 2013 used "blocks of randomisation, with stratification by age (70–79 y and ≥ 80 y) and country".

The other 8 trials provided no details on the randomisation process and we therefore classified them as having an unclear risk of bias for this domain (Berger 1998; Chlibek 2014; Gilderman 2008; Levin 2000; Mills 2010; Murray 2011; Oxman 2005; Tyring 2007).

Allocation (selection bias): allocation criteria

We classified Chlibek 2013, Diez‐Domingo 2015, Lal 2015, Oxman 2005, Vermeulen 2012 and Vesikari 2013 as having low risk of bias because of adequate allocation concealment described by the trial authors as follows. Chlibek 2013: "Treatments were allocated at each site using a central randomisation system on the Internet". Diez‐Domingo 2015: "Allocation schedules were generated using a 1:1 ratio with permuted blocks of 4‐6". Lal 2015: "Participants were stratified according to region and age group (50 to 59, 60 to 69, and ≥70 years)". Oxman 2005: "Each study site received randomly ordered vials of zoster vaccine and placebo in separate boxes for each age stratum". Vermeulen 2012: "Allocation numbers were assigned sequentially by the study site personnel to subjects who met the study eligibility criteria, beginning with the lowest number available at the study centre, after informed consent and medical history had been obtained. The allocation schedule was generated by a sponsor statistician not otherwise associated with the zoster vaccine program". Vesikari 2013: "The allocation schedule was generated using balanced permuted blocks of randomisation"

Berger 1998, Chlibek 2014, Gilderman 2008, Levin 2000, Mills 2010, Murray 2011 and Tyring 2007 did not report details of allocation concealment and we therefore classified these trials as having an 'unclear' risk of bias for this domain.

Blinding (performance bias and detection bias)

8 trials were double‐blind and we considered them at low risk for this domain (Berger 1998; Chlibek 2013; Gilderman 2008; Lal 2015; Murray 2011; Oxman 2005; Tyring 2007; Vermeulen 2012).

The Berger 1998 trial had 4 arms: 3 received different concentrations of a live attenuated VZV/Oka vaccine under double‐blind conditions. The 4th arm used a pneumococcal polysaccharide vaccine as a control for reactogenicity and immune response, under single‐blind conditions

Chlibek 2013 stated that "Both vaccine recipients and observers responsible for evaluations were blinded to which formulation was administered".

Gilderman 2008 included the following comment: "Double‐blind, with in‐house blinding. The vaccine and placebo were indistinguishable from each other."

Lal 2015 reported "Because the appearance of the reconstituted HZ/su vaccine differed from the placebo solution, injections were prepared and administered by study staff who did not participate in any study assessment."

In Murray 2011, the authors reported that "The zoster vaccine and placebo were reconstituted with sterile diluent immediately prior to administration, and were indistinguishable from each other in appearance. Placebo was the vaccine stabiliser of zoster vaccine with no live virus. An independent Data Monitoring Committee was established for continuous safety oversight during the study."

Oxman 2005 provided the following statement: "Since the reconstituted zoster vaccine had a different appearance from the placebo, reconstitution and administration were performed by technicians who did not otherwise interact with subjects, evaluate outcomes or adverse events, answer the telephone or enter study data."

Tyring 2007 states "Blinded subject, investigator and sponsor. The 2 potency formulations were indistinguishable in appearance".

Vermeulen 2012 declares that "The subject, investigator, clinical study site personnel, and sponsor personnel directly involved in the study were blinded to whether the subject received zoster vaccine or placebo. They remained blinded until all subjects completed the study. The clinical materials were prepared by an unblinded vaccine coordinator at each clinical site, because of differences in the turbidity of the study vaccine and placebo. Each vial of vaccine or placebo was labelled with a subject‐specific allocation number. The unblinded vaccine coordinator reconstituted the study vaccine/placebo and wrapped the syringe in an opaque label containing subject allocation number and time of reconstitution. The unblinded vaccine coordinator did not have any contact with the subject and did not disclose the contents of the syringe to the person administering the study vaccine/placebo."

We classified 3 trials as having a 'low risk of bias' only for the domain "blinding of participants and personnel (performance bias)" although "personnel were not blinded" because the participants themselves were blinded and they were the ones who described adverse events in diary cards (Chlibek 2014; Diez‐Domingo 2015; Vesikari 2013). Please see below:

Chlibek 2014 described: "solicited local reactions (pain, redness and swelling) and general reactions (fatigue, fever, headache and myalgia) were recorded by subjects on diary cards for seven days after each vaccination".

Diez‐Domingo 2015 stated: "Between visit 1 and 2, the participants were given a diary card to record their temperature if they were febrile (oral temperature ≥38.3 ◦C), occurrence of any solicited injection‐site (erythema, swelling and pain) adverse reactions (Days 0–4) and any unsolicited injection‐site adverse reactions, varicella, varicella‐like rashes, HZ and zoster‐like rashes and other systemic adverse events (AEs) (Days 0–28). They were also asked to report any serious AEs (SAEs) that occurred at any time during the study".

Vesikari 2013 provided the following description: "Solicited injection‐site reactions (erythema, swelling, and pain) occurring within 4 days of vaccination were recorded by participants in a diary card. Other injection‐site reactions and systemic AEs were recorded in the diary card for up to 28 d following each vaccination."

1 trial was an open study and we considered it to be at high risk of bias for blinding (Levin 2000). We classified Mills 2010 as 'unclear risk of bias' because the authors did not provide any information on blinding.

Incomplete outcome data (attrition bias)

We classified Chlibek 2013, Chlibek 2014, Diez‐Domingo 2015, Gilderman 2008, Murray 2011, Oxman 2005, Tyring 2007, Vermeulen 2012 and Vesikari 2013 as 'low risk' in this domain because the flow of patients was clear. Mills 2010 had no data on the first arm of the cross‐over study and we therefore classified it as 'high risk'. We also classified Lal 2015 as high risk of bias because the patient flow is not clear. We classified Berger 1998 and Levin 2000 as 'unclear risk' as they did not provide any information for this domain.

Selective reporting (reporting bias)

We classified the following studies as 'low risk' in this domain. In Berger 1998, the adverse events originally defined by the authors were presented for all groups. Chlibek 2013 presented the adverse events originally defined by the authors in all groups that received 2 doses of 2 different amounts of adjuvant plus gE subunit VZV, unadjuvanted gE or saline. Chlibek 2014 also presented the adverse events associated with 2 doses of different amounts of adjuvanted gE, unadjuvanted gE or saline. Diez‐Domingo 2015 presented all adverse events proposed in the methodology in both groups (intramuscular versus subcutaneous zoster vaccine). Gilderman 2008 reported all adverse events that the investigators selected, for both groups (refrigerated versus frozen zoster vaccines). In Lal 2015, the data for efficacy and safety of the adjuvanted recombinant zoster vaccine proposed in the methods were described in the results. Mills 2010 described in the results all of the adverse events listed in the methods. Murray 2011 presented in the results all the serious adverse events that were defined in the methods section. Oxman 2005 reported in the results all the data on effectiveness and adverse events that the authors proposed in their methodology. Tyring 2007 provided in the results all the adverse events defined in the methods section, for both higher‐potency and lower‐potency zoster vaccines. Vermeulen 2012 described in their results all adverse events listed by the authors in the methods for both groups and Vesikari 2013 reported all the data that had been proposed in their methodology in the results section, for the 3 groups who received 2 doses of zoster vaccines given at different times or a single dose.

We classified Levin 2000 as having an 'unclear' risk of bias for this domain because it was basically a study that analysed immune response.

Other potential sources of bias

We did not identify any significant aspects pertaining to this domain.
Figuras y tablas -
Table 1. Comprehensive risk of bias
Ir a la tabla de la revisión
Table 2. Adverse events of available live attenuated VZV zoster vaccine

Comparison (studies)

Results

Available live attenuated VZV zoster vaccineversus placebo

(Mills 2010; Murray 2011; Oxman 2005; Vermeulen 2012)

The risk of herpes zoster‐like rash up to 42 days post‐vaccination (Oxman 2005) was lower in the vaccinated group (RR 0.47, 95% CI 0.27 to 0.84) than the placebo group but without a significant RD (Analysis 1.3.7).

The following systemic AEs were not significantly different between the groups receiving zoster vaccine or placebo: systemic AEs (Mills 2010; Oxman 2005; Vermeulen 2012), systemic pruritus (Vermeulen 2012), varicella‐like rash not at injection site (from day of vaccination to day 42) (Oxman 2005; Vermeulen 2012), rash unrelated to HZ (from day of vaccination to day 42) (Oxman 2005), 1 or more SAE (including death) (Mills 2010; Murray 2011; Oxman 2005; Vermeulen 2012), vaccine‐related SAEs (Mills 2010; Murray 2011; Oxman 2005), discontinuation due to a vaccine‐related AE (Mills 2010; Vermeulen 2012), hospitalisation (Oxman 2005), and hospitalisation related to HZ (Oxman 2005).

Specific injection site AEs were more frequent in the vaccinated group. Specific risks for individual AEs were:

Varicella‐like rash at injection site (up to day 42) was also more frequent in the vaccinated group: RR 2.86, 95% CI 1.21 to 6.76 (Analysis 1.3.23) (Oxman 2005), but without a significant RD due to the small number of events.

Duration of injection site AEs

In general, injection site AEs lasted longer in the zoster vaccine group. There were significant differences with respect to the duration of the following local AEs: erythema, with a mean difference (MD) of 2.40 days (95% CI 1.56 to 3.24) (Analysis 1.4.1), swelling MD 1.90 days (95% CI 1.35 to 2.45) (Analysis 1.4.2) and pruritus MD 2.40 days (95% CI 1.32 to 3.48) (Analysis 1.4.5).

The duration of pain and haematoma did not differ significantly between the groups, MD 1.00 (95% CI ‐0.10 to 2.10) (Analysis 1.4.3) and MD ‐0.50 (95% CI ‐5.52 to 4.52) (Analysis 1.4.6) respectively.

The duration of rash was longer in the placebo compared to the vaccine group: RR ‐16.60 (95% CI ‐33.68 to 0.48) (Analysis 1.4.4).

High‐potency versus low‐potency zoster vaccine (Tyring 2007)

The comparison of high versus low‐potency zoster vaccine yielded no significant differences between groups for the following AEs: vaccine‐related AEs, systemic vaccine‐related AEs and vaccine‐related serious AEs (death).

Refrigerated versus frozen zoster vaccine

(Gilderman 2008)

Compared refrigerated versus frozen zoster vaccine and reported no significant differences between groups for the following AEs: 1 or more AEs, vaccine‐related AEs, systemic AEs, systemic vaccine‐related AEs, serious AEs, vaccine‐related serious AEs or death. However, there were more injection site AEs in the group receiving frozen vaccines (RR 0.77, 95% CI 0.60 to 0.98) (Analysis 3.1.8).

Zoster vaccine versus pneumo 23

(Berger 1998)

One study compared 3 different concentrations of plaque‐forming units (pfu) of live attenuated VZV and presented the following adverse events:

3200 pfu VZV/dose versus pneumo 23

There was a lower incidence of 1 or more injection site reactions in the group vaccinated with the 3200 pfu/dose zoster vaccine (RR 0.61, 95% CI 0.41 to 0.91) (Analysis 5.1.1) as well as pain at the injection site (RR 0.49, 95% CI 0.30 to 0.81) (Analysis 5.1.3).

There were no significant differences between the 3200 pfu/dose zoster vaccine and the pneumo 23 vaccine for the following local adverse events: induration (≥ 2 cm diameter injection site), probably vaccine‐related injection site pain, redness (≥ 2 cm diameter injection site), pruritus or vesicles (no patients had vesicles in the 3200 pfu/dose zoster vaccine nor the pneumo 23 groups).

8500 pfu VZV/dose versus pneumo 23

There was a lower incidence of 1 or more injection site reaction in the group vaccinated with the 8500 pfu/dose zoster vaccine (RR 0.63, 95% CI 0.43 to 0.93) (Analysis 5.2.1).

There were no significant differences for the following injection site AEs between participants who received the 8500 pfu/dose VZV vaccine and those who received the pneumo 23 vaccine: induration (≥ 2 cm diameter injection site), pain (injection site), probably vaccine‐related injection site pain, redness, pruritus and vesicles.

41,650 pfu VZV/dose VZV versus pneumo 23

Participants receiving the 41,650 pfu/dose zoster vaccine had significantly lower rates of one or more injection site reaction (RR 0.41, 95% CI 0.24 to 0.68) (Analysis 5.3.1) and pain at injection site (RR 0.43, 95% CI 0.25 to 0.74) (Analysis 5.3.3) than those receiving the pneumo 23 vaccine.

There were no significant differences between the groups for the following injection site AEs: induration (≥ 2 cm diameter injection site), probably vaccine‐related injection site pain, redness (≥ 2 cm diameter injection site), pruritus and vesicles (no patients had vesicles in the 41,650 pfu/dose zoster vaccine nor the pneumo 23 vaccine groups).

Zoster vaccine intramuscular route versus zoster vaccine subcutaneous route

(Diez‐Domingo 2015)

Compared intramuscular (IM) versus subcutaneous (SC) zoster vaccine and reported that compared to the IM group, participants who received SC vaccines had a significantly higher incidence of the following AEs:

  • at least 1 adverse event (AE): RR 0.68 (95% CI 0.56 to 0.82), RD ‐0.22 (95% CI ‐0.32 to ‐0.12) and NNTH 4.5 (95% CI 3.1 to 8.33) (Analysis 6.1.1);

  • vaccine‐related AE: RR 0.58, 95% CI 0.47 to 0.72, RD ‐0.28, 95% CI ‐0.38 to ‐0.18 and NNTH 3.6, 95% CI 2.6 to 5.55 (Analysis 6.1.2);

  • solicited injection site reaction: RR 0.53, 95% CI 0.42 to 0.67, RD ‐0.30, 95% CI ‐0.40 to ‐0.20 and NNTH 1.8, 95% CI 2.5 to 5 (Analysis 6.1.6);

  • injection site erythema: RR 0.30, 95% CI 0.21 to 0.44, RD ‐0.37, 95% CI‐0.46 to ‐0.28 and NNTH 2.7, 95% CI 2.1 to 3.5 (Analysis 6.1.8);

  • injection site pain: RR 0.65, 95% CI 0.47 to 0.88, RD ‐0.14, 95% CI ‐0.24 to ‐0.04 and NNTH 7.1, 95% CI 4.2 to 25 (Analysis 6.1.10);

  • injection site swelling: RR 0.37, 95% CI 0.24 to 0.56, RD ‐0.24, 95% CI ‐0.32 to ‐0.15 and NNTH 4.2, 95% CI 3.1 to 6.7 (Analysis 6.1.12);

  • injection site pruritus: RR 0.27, 95% CI 0.08 to 0.97, RD ‐0.05, 95% CI ‐0.09 to ‐0.00 and NNTH 20.0, 95% CI 0 to 11.0 to (Analysis 6.1.14).

There were no significant differences between groups for the following AEs: all systemic AEs: RR 1.03, 95% CI 0.70 to 1.51 (Analysis 6.1.3); vaccine‐related systemic AE: RR 0.93, 95% CI 0.44 to 1.98 (Analysis 6.1.4); headache considered as vaccine‐related by the investigator: RR 0.75, 95% CI 0.17 to 3.32 (Analysis 6.1.5); unsolicited injection site reaction: RR 0.65 95% CI 0.29 to 1.45 (Analysis 6.1.7); severe injection site erythema (> 10 cm): RR 0.67 95% CI 0.11 to 3.96 (Analysis 6.1.9); severe injection site pain (inability to work or usual activity): RR 1.01, 95% CI 0.14 to 7.06 (Analysis 6.1.11); severe injection site swelling (> 10 cm): RR 0.25, 95% CI 0.03 to 2.23 (Analysis 6.1.13).

No participant withdrew from the trial because of AE (Analysis 6.1.15).

2 doses of a zoster vaccine versus a single dose and also 2 doses given at different intervals

(Vesikari 2013)

Zoster vaccine 1‐month schedule versus zoster vaccine 3‐month schedule

There was no statistical difference between participants who received the doses of zoster vaccine 2 months apart compared to those receiving the doses 3 months apart: AE RR 1.10, 95% CI 0.91 to 1.31 (Analysis 7.1.1), vaccine‐related AE RR 1.00, 95% CI 0.81 to 1.24 (Analysis 7.1.2); serious AE RR 0.95, 95% CI 0.14 to 6.70 (Analysis 7.1.3); withdrawal due to AE RR 2.86, 95% CI 0.12 to 69.80 (Analysis 7.1.5); systemic AE RR 1.34, 95% CI 0.90 to 2.00 (Analysis 7.1.8); vaccine‐related systemic AE RR 1.27, 95% CI 0.45 to 3.60 (Analysis 7.1.9); rash of interest non‐injection site rashes RR 0.95, 95% CI 0.06 to 15.14 (Analysis 7.1.10); varicella/varicella‐like rash RR 0.95, 95% CI 0.06 to 15.14 (Analysis 7.1.11); injection site reaction RR 0.99, 95% CI 0.80 to 1.23 (Analysis 7.1.13); solicited injection site reaction RR 1.00, 95% CI 0.81 to 1.25 (Analysis 7.1.14); unsolicited injection site reaction RR 0.41, 95% CI 0.11 to 1.56 (Analysis 7.1.15); erythema injection site RR 1.01, 95% CI 0.80 to 1.27 (Analysis 7.1.16); pain injection site RR 0.84, 95% CI 0.57 to 1.25 (Analysis 7.1.17); swelling injection site RR 1.05, 95% CI 0.75 to 1.47 (Analysis 7.1.18).

No participants, from either group, reported the following AE: vaccine‐related serious AE (Analysis 7.1.4); vaccine‐related withdrawal due to AE (Analysis 7.1.6); non‐serious vaccine‐related withdrawal due to AE (Analysis 7.1.7) and herpes zoster/zoster‐like rash (Analysis 7.1.12).

Zoster vaccine 1 month schedule versus zoster vaccine single dose

Only participants with systemic AE: there were significant differences in favour of the 2 doses 1 month apart, with a higher incidence in the single dose group: RR 0.74, 95% CI 0.56 to 0.97, RD ‐0.07, 95% CI ‐0.13 to ‐0.01 and NNTH 14.3, 95% CI 7.6 to 100 (Analysis 7.2.8).

For most AEs, there was no statistical difference: AE RR 0.92, 95% CI 0.80 to 1.05 (Analysis 7.2.1), vaccine‐related AE RR 0.91, 95% CI 0.77 to 1.08 (Analysis 7.2.2); serious AE RR 0.72, 95% CI 0.16 to 3.30 (Analysis 7.2.3); withdrawal due to AE RR 0.36, 95% CI 0.05 to 2.82 (Analysis 7.1.5); vaccine‐related withdrawal due to AE RR 0.21, 95% CI 0.01 to 3.74 (Analysis 7.2.6); non‐serious vaccine‐related withdrawal due to AE RR 0.21, 95% CI 0.01 to 3.74 (Analysis 7.2.7); vaccine‐related systemic AE RR 0.54, 95% CI 0.26 to 1.12 (Analysis 7.2.9); rash of interest non‐injection site rashes RR 1.61, 95% CI 0.15 to 17.72 (Analysis 7.2.10); varicella/varicella‐like rash RR 9.66, 95% CI 0.39 to 236.25 (Analysis 7.2.11); herpes zoster/zoster‐like rash RR 0.64, 95% CI 0.03 to 13.36 (Analysis 7.2.12); injection site reaction RR 0.93, 95% CI 0.78 to 1.10 (Analysis 7.2.13); solicited injection site reaction RR 0.94, 95% CI 0.79 to 1.11 (Analysis 7.2.14); unsolicited injection site reaction RR 0.35, 95% CI 0.11 to 1.13 (Analysis 7.2.15); injection site erythema RR 0.98, 95% CI 0.81 to 1.17 (Analysis 7.2.16); injection site pain RR 0.74, 95% CI 0.54 to 1.01 (Analysis 7.2.17); injection site swelling RR 1.08, 95% CI 0.82 to 1.41 (Analysis 7.2.18).

There were no participants with vaccine‐related serious AE in either group (Analysis 7.2.4).

Zoster vaccine 3 month schedule versus zoster vaccine single dose

The participants in the group that received a single dose had a higher incidence of the following AE in comparison to those in the group that received 2 doses, 3 months apart: AEs RR 0.84, 95% CI 0.72 to 0.97; RD ‐0.09; 95% CI ‐0.17 to ‐0.02 and NNTH 11.1, 95% CI 5.9 to 50 (Analysis 7.3.1), systemic AEs RR 0.55, 95% CI 0.39 to 0.76, RD ‐0.13, 95% CI ‐0.18 to ‐0.07 and NNTH 7.6, 95% CI 5.6 to 14.3 (Analysis 7.3.8) and vaccine‐related systemic AE RR 0.42, 95% CI 0.18 to 0.98), RD ‐0.04, 95% CI ‐0.06 to ‐0.01 and NNTH 25.0, 95% CI 16.6 to 100 (Analysis 7.3.9). There were no significant differences between these groups in relation to the following AEs: vaccine‐related AE RR 0.91, 95% CI 0.77 to 1.08 (Analysis 7.3.2); serious AE RR 0.75, 95% CI 0.16 to 3.46 (Analysis 7.3.3); withdrawal due to AE RR 0.18, 95% CI 0.01 to 3.04 (Analysis 7.3.5); vaccine‐related withdrawal due to AE RR 0.23, 95% CI 0.01 to 3.93 (Analysis 7.3.6); non‐serious vaccine‐related withdrawal due to AE RR 0.23, 95% CI 0.01 to 3.93 (Analysis 7.3.7); rash of interest non‐injection site rashes RR 1.69, 95% CI 0.15 to 18.60 (Analysis 7.3.10); varicella/varicella‐like rash RR 10.14, 95% CI 0.41 to 247.92 (Analysis 7.3.11); herpes zoster/zoster‐like rash RR 0.68, 95% CI 0.03 to 14.02 (Analysis 7.3.12); injection site reaction RR 1.10, 95% CI 0.79 to 1.11 (Analysis 7.3.13); solicited injection site reaction RR 0.93, 95% CI 0.78 to 1.11 (Analysis 7.3.14); unsolicited injection site reaction RR 0.85, 95% CI 0.38 to 1.91 (Analysis 7.3.15); injection site erythema RR 0.97, 95% CI 0.80 to 1.17 (Analysis 7.3.16); injection site pain RR 0.87, 95% CI 0.65 to 1.17 (Analysis 7.3.17); injection site swelling RR 1.03, 95% CI 0.77 to 1.36 (Analysis 7.3.18).

There were no participants with vaccine‐related serious AE in either group (Analysis 7.3.4).

AE: adverse event
CI: confidence interval
HZ: herpes zoster
RD: risk difference
RR: risk ratio
SC: subcutaneous
VZV: varicella zoster virus

Figuras y tablas -
Table 2. Adverse events of available live attenuated VZV zoster vaccine
Ir a la tabla de la revisión
Table 3. Adverse events of adjuvanted recombinant VZV subunit zoster vaccine

Comparison (studies)

Results

Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline

(Chlibek 2013)

Compared 4 groups that received either lower (AS01E) or higher (AS01B) volumes of adjuvants plus gE subunit VZ or unadjuvanted gE or saline injections.

50 μg gE/AS01E versus 50 μg gE/AS01B

There was a significantly higher incidence of AEs in the participants who received a higher quantity of adjuvant (AS01B):

  • any symptom RR 0.89, 95% CI 0.80 to 0.99; RD ‐0.09, 95% CI ‐0.18 to ‐0.01 and NNTH 11.1, 95% CI 5.6 to 100.0 (Analysis 8.1.1);

  • fatigue RR 0.73, 95% CI 0.55 to 0.96, RD ‐0.13 95% CI ‐0.24 to ‐0.02 and NNTH 7.7, 95% CI 4.2 to 50.0 (Analysis 8.1.5);

  • headache RR 0.67, 95% CI 0.47 to 0.94, RD ‐0.13 95% CI ‐0.23 to ‐0.02 and NNTH 7.7, 95% CI 4.3 to 50.0 (Analysis 8.1.11);

  • any local symptom RR 0.85, 95% CI 0.75 to 0.96, RD ‐0.13 95% CI ‐0.22 to ‐0.04 and NNTH 7.7, 95% CI 4.5 to 25.0 (Analysis 8.1.15);

  • local pain RR 0.84, 95% CI 0.74 to 0.95, RD ‐0.14 95% CI ‐0.23 to ‐0.04 and NNTH 7.1, 95% CI 4.3 to 25.0 (Analysis 8.1.17);

  • local redness RR 0.59, 95% CI 0.39 to 0.91, RD ‐0.12 95% CI ‐0.21 to ‐0.02 and NNTH 8.3, 95% CI 4.7 to 50.0 (Analysis 8.1.19).

There were no significant differences between groups for all other AEs: any grade 3 symptom; any general symptom, any general grade 3 symptom, grade 3 fatigue, fever, gastrointestinal symptoms, grade 3 gastrointestinal symptoms, grade 3 headache, myalgia, grade 3 myalgia, any grade 3 local symptom, local grade 3 pain, local grade 3 redness, local swelling and local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AE.

No participants had grade 3 fever in either group.

50 μg gE/AS01E versus 50 μg gE/saline (unadjuvanted)

  • any symptom RR 1.76, 95% CI 1.34 to 2.32, RD 0.33, 95% CI 0.20 to 0.47 and NNTH was 3.0, 95% CI 2.1 to 5.0 (Analysis 8.2.1);

  • any general symptom RR 1.67, 95% CI 1.17 to 2.40, RD 0.22, 95% CI 0.09 to 0.36 and NNTH was 4.5, 95% CI 2.7 to 11.1 (Analysis 8.2.3);

  • fever RR 18.25, 95% CI 1.12 to 298.73, RD 0.12, 95% CI 0.06 to 0.18 and NNTH was 8.3, 95% CI 5.5 to 16.6 (Analysis 8.2.7);

  • myalgia RR 2.00, 95% CI 1.14 to 3.52, RD 0.16, 95% CI 0.05 to 0.28 and NNTH was 6.25, 95% CI 3.5 to 20.0 (Analysis 8.2.13);

  • any local symptom RR 3.05, 95% CI 1.99 to 4.69, RD 0.48, 95% CI 0.36 to 0.60 and NNTH was 2.0, 95% CI 1.6 to 2.7 (Analysis 8.2.15);

  • local pain RR 3.64, 95% CI 2.25 to 5.90, RD 0.51, 95% CI 0.39 to 0.62 and NNTH was 1.9, 95% CI 1.6 to 2.5 (Analysis 8.2.17);

  • local redness RR 4.25, 95% CI 1.33 to 13.57, RD 0.13, 95% CI 0.06 to 0.21 and NNTH was 7.6, 95% CI 4.7 to 16.6 (Analysis 8.2.19);

  • local swelling RR 4.08, 95% CI 1.27 to 13.08, RD 0.13, 95% CI 0.05 to 0.20 and NNTH was 7.6, 95% CI 5.0 to 20 (Analysis 8.2.21).

All these AE differences were favourable to the unadjuvanted gE group.

There were no significant differences between the groups for the following AEs: any grade 3 symptom, any general grade 3 symptom, fatigue, grade 3 fatigue, gastrointestinal symptoms, grade 3 gastrointestinal symptoms, headache, grade 3 myalgia, any local grade 3 symptom, local grade 3 pain, local grade 3 redness and local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AE.

No participants had grade 3 fever or grade 3 headache in either group.

50 μg gE/AS01B versus 50 μg gE/saline (unadjuvanted)

  • any symptom RR 1.98, 95% CI 1.51 to 2.58, RD 0.43, 95% CI 0.30 to 0.55 and NNTH 2.3, 95% CI 1.8 to 3.3 (Analysis 8.3.1);

  • any general symptom RR 1.93, 95% CI 1.36 to 2.73, RD 0.30, 95% CI 0.17 to 0.44 and NNTH 3.3, 95% CI 2.2 to 5.8 (Analysis 8.3.3)

  • fatigue RR 2.19, 95% CI 1.38 to 3.48, RD 0.26, 95% CI 0.14 to 0.38 and NNTH 3.8, 95% CI 2.6 to 7.1 (Analysis 8.3.5);

  • fever RR 24.99, 95% CI 1.54 to 404.89, RD 0.17, 95% CI 0.10 to 0.23 and NNTH 5.8, 95% CI 4.3 to 10.0 (Analysis 8.3.7);

  • headache RR 2.73, 95% CI 1.48 to 5.03, RD 0.24, 95% CI 0.13 to 0.35 and NNTH 4.1, 95% CI 2.8 to 7.6 (Analysis 8.3.11);

  • myalgia RR 2.51, 95% CI 1.45 to 4.36, RD 0.25, 95% CI 0.13 to 0.36 and NNTH 4.0, 95% CI 2.7 to 7.6 (Analysis 8.3.13);

  • any local symptom RR 3.61, 95% CI 2.36 to 5.50, RD 0.61, 95% CI 0.49 to 0.72 and NNTH 1.6, 95% CI 1.3 to 2.0 (Analysis 8.3.15);

  • local pain RR 4.35, 95% CI 2.70 to 7.00, RD 0.64, 95% CI 0.53 to 0.75 and NNTH 1.5, 95% CI 1.3 to 1.8 (Analysis 8.3.17);

  • local redness RR 7.14, 95% CI 2.29 to 22.22, RD 0.25, 95% CI 0.17 to 0.34 and NNTH 4.0, 95% CI 2.9 to 5.8 (Analysis 8.3.19);

  • local swelling RR 3.73, 95% CI 1.16 to 12.02, RD 0.11, 95% CI 0.04 to 0.19 and NNTH 9.0, 95% CI 5.2 to 25 (Analysis 8.3.21).

All these AE differences were favourable to unadjuvanted gE.

There were no significant differences between the groups for the following AEs: any grade 3 symptom, any general grade 3 symptom, grade 3 fatigue, gastrointestinal symptoms, grade 3 headache, grade 3 myalgia, any local grade 3 symptom, local grade 3 pain, local grade 3 redness and local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AE.

No participant had grade 3 fever or grade 3 gastrointestinal symptoms in either group.

50 μg gE/AS01E versus saline

  • any symptom RR 3.67, 95% CI 1.97 to 6.83, RD 0.56, 95% CI 0.42 to 0.71 and NNTH 1.7, 95% CI 1.4 to 2.3 (Analysis 8.4.1);

  • any general symptom RR 2.99, 95% CI 1.51 to 5.92, RD 0.37, 95% CI 0.22 to 0.51 and NNTH 9.1, 95% CI 1.9 to 4.5 (Analysis 8.4.3);

  • myalgia RR 6.25, 95% CI 1.59 to 24.55, RD 0.28, 95% CI 0.17 to 0.38 and NNTH 3.5, 95% CI 2.6 to 5.8 (Analysis 8.4.13);

  • any local symptom RR 9.01, 95% CI 3.03 to 26.82, RD 0.63, 95% CI 0.52 to 0.74 and NNTH 1.5, 95% CI 1.3 to 1.9 (Analysis 8.4.15);

  • local pain RR 8.84, 95% CI 2.97 to 26.33, RD 0.62, 95% CI 0.51, 0.73 and NNTH 1.6, 95% CI 1.3 to 1.9 (Analysis 8.4.17).

All differences in these AEs were favourable to the saline group.

There were no significant differences in the following AEs between the groups:any grade 3 symptom, any general grade 3 symptom, fatigue, grade 3 fatigue, fever, gastrointestinal symptoms, grade 3 gastrointestinal symptoms, headache, grade 3 headache, grade 3 myalgia, any local grade 3 symptom, local grade 3 pain, local redness, local grade 3 redness, local swelling and local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AE

No participants had grade 3 fever or grade 3 headache in either group.

50 μg gE/AS01B versus saline

  • any symptom RR 4.12, 95% CI 2.22 to 7.64, RD 0.66, 95% CI 0.52 to 0.80 and NNTH 1.5, 95% CI 1.2 to 1.9 (Analysis 8.5.1);

  • any general symptom RR 3.44, 95% CI 1.74 to 6.79, RD 0.45, 95% CI 0.30 to 0.59 and NNTH 2.2, 95% CI 1.6 to 3.3 (Analysis 8.5.3);

  • fatigue RR 2.61, 95% CI 1.31 to 5.19, RD 0.30, 95% CI 0.15 to 0.44 and NNTH 1.3, 95% CI 2.2 to 6.6 (Analysis 8.5.5);

  • headache RR 3.55, 95% CI 1.37 to 9.17, RD 0.27, 95% CI 0.14 to 0.39 and NNTH 3.7, 95% CI 2.5 to 7.1 (Analysis 8.5.11);

  • myalgia RR 7.85, 95% CI 2.01 to 30.67, RD 0.36, 95% CI 0.25 to 0.47 and NNTH 2.7, 95% CI 2.1 to 4.0 (Analysis 8.5.13);

  • any local symptom RR 10.64, 95% CI 3.58 to 31.59, RD 0.76, 95% CI 0.66 to 0.86 and NNTH 1.3, 95% CI 1.1 to 1.5 (Analysis 8.5.15);

  • local pain RR 10.56, 95% CI 3.55 to 31.34, RD 0.75, 95% CI 0.65 to 0.86 and NNTH 1.3, 95% CI 1.1 to 1.5 (Analysis 8.5.17);

  • local redness RR 22.99, 95% CI 1.45 to 365.01, RD 0.29, 95% CI 0.21 to 0.37 and NNT 3.4, 95% CI 2.7 to 4.7 (Analysis 8.5.19).

All AE differences were favourable to saline.

There was no significant difference in AEs between groups for the following: any grade 3 symptom, any general grade 3 symptom, grade 3 fatigue, fever, gastrointestinal symptoms, grade 3 gastrointestinal symptoms, grade 3, headache, grade 3 myalgia, any local grade 3 symptom, local grade 3 pain, local grade 3 redness, local swelling and local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AEs.

No participant had grade 3 fever in either group.

50 μg gE/saline (unadjuvanted) versus saline

  • any symptom RR 2.08, 95% CI 1.07 to 4.06, RD 0.23, 95% CI 0.06 to 0.40 and NNTH 4.3, 95% CI 2.5 to 16.6 (Analysis 8.6.1), favourable to saline.

There were no significant differences between groups for the following AEs: any grade 3 symptom, any general symptom, any general grade 3 symptom, fatigue, grade 3 fatigue, fever, gastrointestinal symptoms, grade 3 gastrointestinal symptoms, headache, myalgia, grade 3 myalgia, any local symptom, local pain, local redness and local swelling or consent withdrawal.

No participant, in either group had grade 3 fever, grade 3 headache, any local grade 3 symptom, local grade 3 pain, local grade 3 redness, local grade 3 swelling, loss to follow‐up and serious AE.

Adjuvanted recombinant VZV subunit zoster vaccine:

three groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline

(Chlibek 2014)

3 groups of VZV plus gE were compared in 3 different quantities, 1 group that received unadjuvanted gE and 1 group that received only saline

25 µg gE/AS01B versus 50 µg gE/AS01B

There was no difference in the incidence of the following AEs: any fatigue, grade 3 fatigue, any fever, grade 3 fever, any headache, grade 3 headache, any myalgia, grade 3 myalgia, local pain, local grade 3 pain, local redness, local grade 3 redness, local swelling, local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AEs.

25 µg gE/AS01B versus 100 µg gE/AS01B

There were no differences in the incidence of the following AEs: any fatigue, grade 3 fatigue, any fever, any headache, grade 3 headache, any myalgia, grade 3 myalgia, local pain, grade 3 local pain, local redness, local grade 3 redness, local swelling, local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AEs.

50 µg gE/AS01B versus 100 µg gE/AS01B

  • any myalgia RR 1.26, 95% CI 1.01 to 1.59, RD 0.11, 95% CI 0.00 to 0.22 and NNTH 9.0, 95% CI 0 to 4.5 (Analysis 9.3.7), favourable to 100 µg gE/AS01B.

There were no differences in the incidence of all the others AEs: any fatigue, grade 3 fatigue, any fever, grade 3 fever, any headache, grade 3 headache, grade 3 myalgia, local pain, local grade 3 pain, local redness, local grade 3 redness, local swelling, local grade 3 swelling, consent withdrawal and serious AEs

25 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE)

  • any fatigue RR 1.89, 95% CI 1.11 to 3.22, RD 0.20, 95% CI 0.06 to 0.33 and NNTH 5.0, 95% CI 3.0 to 16.6 (Analysis 9.4.1);

  • any myalgia RR 2.71, 95% CI 1.46 to 5.03, RD 0.28, 95% CI 0.16 to 0.41 and NNTH 3.5, 95% C I 2.4 to 6.2 (Analysis 9.4.7);

  • local pain RR 4.21, 95% CI 2.30 to 7.70, RD 0.53, 95% CI 0.41 to 0.66 and NNTH 1.8, 95% CI 1.5 to 2.4 (Analysis 9.4.9);

  • local redness RR 11.20, 95% CI 2.84 to 44.15, RD 0.38, 95% CI 0.29 to 0.47 and NNTH 2.6, 95% CI 2.1 to 3.4 (Analysis 9.4.11);

  • local swelling RR 14.49, 95% CI 2.04 to 102.66, RD 0.25, 95% CI 0.17 to 0.33 and NNTH 4.0, 95% CI 3.0 to 5.8 (Analysis 9.4.13).

All these differences in AEs were favourable to unadjuvanted gE.

There were no differences in the incidence of the following AEs: grade 3 fatigue, any fever, any headache, grade 3 headache, grade 3 myalgia, local grade 3 pain, local grade 3 redness, local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AEs.

No participant had grade 3 fever in either of the groups.

50 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE)

  • any fatigue RR 2.30, 95% CI 1.37 to 3.88, RD 0.29, 95% CI 0.16 to 0.42 and NNTH 3.4, 95% CI 2.3 to 6.2 (Analysis 9.5.1);

  • any headache RR 2.13, 95% CI 1.14 to 4.01, RD 0.19, 95% CI 0.07 to 0.31 and NNTH 5.2, 95% CI 3.2 to 14.2 (Analysis 9.5.5);

  • any myalgia RR 3.22, 95% CI 1.74 to 5.94, RD 0.37, 95% CI 0.24 to 0.49 and NNTH 2.7, 95% CI 2.0 to 4.1 (Analysis 9.5.7);

  • local pain RR 4.37, 95% CI 2.39 to 8.00, RD 0.56, 95% CI 0.44 to 0.68 and NNTH 1.7, 95% CI 1.4 to 2.2 (Analysis 9.5.9);

  • local redness RR 10.73, 95% CI 2.72 to 42.37, RD 0.36, 95% CI 0.27 to 0.45 and NNTH 2.7, 95% CI 2.2 to 3.7 (Analysis 9.5.11);

  • local swelling RR 10.73, 95% CI 1.50 to 76.64, RD 0.18, 95% CI 0.11 to 0.25 and NNTH 5.5, 95% CI 4.0 to 9.0 (Analysis 9.5.13).

All these differences of AEs were favourable to unadjuvanted gE.

There were no differences in the incidence of the following AEs: grade 3 fatigue, any fever, grade 3 headache, grade 3 myalgia, local grade 3 pain, local grade 3 redness, local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AEs.

No participant had grade 3 fever in either of the groups

100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE)

  • any fatigue RR 1.99, 95% CI 1.17 to 3.37, RD 0.22, 95% CI 0.09 to 0.35 and NNTH 4.5, 95% CI 2.8 to 11.1 (Analysis 9.6.1);

  • any headache RR 1.85, 95% CI 0.98 to 3.51, RD 0.14, 95% CI 0.02 to 0.26 and NNTH 7.1, 95% CI 3.8 to 50.0 (Analysis 9.6.5);

  • any myalgia RR 2.55, 95% CI 1.37 to 4.74, RD 0.26, 95% CI 0.13 to 0.38 and NNTH 3.8, 95% CI 2.6 to 7.6 (Analysis 9.6.7);

  • local pain RR 4.44, 95% CI 2.43 to 8.11, RD 0.57, 95% CI 0.45 to 0.69 and NNTH 1.7, 95% CI 1.4 to 2.2 (Analysis 9.6.9);

  • local redness RR 11.13, 95% CI 2.82 to 43.88, RD 0.38, 95% CI 0.28 to 0.47 and NNTH 2.6, 95% CI 2.1 to 3.5 (Analysis 9.6.11);

  • local swelling RR 14.73, 95% CI 2.08 to 104.31, RD 0.25, 95% CI 0.18 to 0.33 and NNTH 4.0, 95% CI 3.0 to 5.5 (Analysis 9.6.13).

All these differences in AEs were favourable to unadjuvanted gE.

There were no differences in the incidence of the following AEs: grade 3 fatigue, any fever, grade 3 headache, grade 3 myalgia, local grade 3 pain, local grade 3 redness, local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AEs.

No participant had grade 3 fever in either of the groups.

25 µg gE/AS01B versus saline + 100 µg gE/AS01B

  • any fatigue RR 1.48, 95% CI 1.09 to 2.00, RD 0.14, 95% CI 0.03 to 0.24 and NNTH 7.1, 95% CI 4.1 to 33.3 (Analysis 9.7.1);

  • any myalgia RR 1.52, 95% CI 1.14 to 2.03, RD 0.15, 95% CI 0.05 to 0.26 and NNTH 6.6, 95% CI 3.8 to 20 (Analysis 9.7.7);

  • local pain RR 1.24, 95% CI 1.05 to 1.47, RD 0.14, 95% CI 0.03 to 0.24 and NNTH 7.1, 95% CI 4.1 to 33.3 (Analysis 9.7.9);

  • local redness RR 1.40, 95% CI 1.04 to 1.88, RD 0.12, 95% CI 0.01 to 0.22 and NNTH 8.3, 95% CI 4.5 to 100.0 (Analysis 9.7.11).

All differences in AEs were favourable to saline + 100 µg gE/AS01B.

There were no differences in the incidence of the following AEs:, any fatigue, grade 3 fever, any headache, grade 3 headache, grade 3 myalgia, local grade 3 pain, local grade 3 redness, local swelling, local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AEs.

No participant had grade 3 fever in either of the groups.

50 µg gE/AS01B versus saline + 100 µg gE/AS01B

  • any fatigue RR 1.80, 95% CI 1.35 to 2.39, RD 0.23, 95% CI 0.12 to 0.33 and NNTH 4.3, 95% CI 3.0 to 8.3 (Analysis 9.8.1);

  • any headache RR 1.63, 95% CI 1.14 to 2.32, RD 0.14, 95% CI 0.04 to 0.23 and NNTH 7.1, 95% CI 4.3 to 25 (Analysis 9.8.5);

  • any myalgia RR 1.81, 95% CI 1.37 to 2.37, RD 0.24, 95% CI 0.14 to 0.34 and NNTH 4.1, 95% CI 2.9 to 7.1 (Analysis 9.8.7);

  • local pain RR 1.29, 95% CI 1.10 to 1.52, RD 0.17, 95% CI 0.06 to 0.27 and NNTH 5.8, 95% CI 3.7 to 16.6 (Analysis 9.8.9).

All differences in AEs were favourable to saline + 100 µg gE/AS01B.

There were no differences in the incidence of the following AEs: grade 3 fatigue, any fever, grade 3 fever, grade 3 headache, grade 3 myalgia, local grade 3 pain, local redness, local grade 3 redness, local swelling, local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AEs.

100 µg gE/AS01B versus saline + 100 µg gE/AS01B

  • any fatigue RR 1.55, 95% CI 1.15 to 2.09, RD 0.16, 95% CI 0.06 to 0.26 and NNTH 6.2, 95% CI 3.8 to 16.6 (Analysis 9.9.1);

  • any fever RR 2.44, 95% CI 1.16 to 5.15, RD 0.08, 95% CI 0.02 to 0.14 and NNTH 12.5, 95% CI 7.1 to 50 (Analysis 9.9.3);

  • any myalgia RR 1.43, 95% CI 1.06 to 1.92, RD 0.13, 95% CI 0.02 to 0.23 and NNTH 7.6, 95% CI 4.3 to 50.0 (Analysis 9.9.7);

  • local pain RR 1.31, 95% CI 1.12 to 1.54, RD 0.18, 95% CI 0.07 to 0.28 and NNTH 5.5, 95% CI 3.5 to 14.2 (Analysis 9.9.9);

  • local redness RR 1.39, 95% CI 1.03 to 1.87, RD 0.12, 95% CI 0.01 to 0.22 and NNTH 8.3, 95% CI 4.5 to 100.0 (Analysis 9.9.11).

All differences in AEs were favourable to saline + 100 µg gE/AS01B.

There were no difference in the incidence of the following AEs: grade 3 fatigue, headache, grade 3 headache, grade 3 myalgia, local grade 3 pain, local grade 3 redness, local swelling, local grade 3 swelling, consent withdrawal, loss to follow‐up and serious AEs.

No participant had grade 3 fever in either of the groups.

Saline + 100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE)

  • local pain RR 3.38, 95% CI 1.84 to 6.23, RD 0.40, 95% CI 0.27 to 0.52 and NNTH 2.5, 95% CI 1.9 to 3.7 (Analysis 9.10.9);

  • local redness RR 8.02, 95% CI 2.02 to 31.88, RD 0.26, 95% CI 0.17 to 0.35 and NNTH 3.8, 95% CI 2.8 to 5.8 (Analysis 9.10.11);

  • local swelling RR 9.82, 95% CI 1.37 to 70.30, RD 0.16, 95% CI 0.09 to 0.23 and NNTH 6.2, 95% CI 4.3 to 11.1 (Analysis 9.10.13).

All differences in AEs were favourable to 100 µg gE/saline.

There were no differences in the incidence of the following AEs: any fatigue, grade 3 fatigue, any fever, any headache, any myalgia, grade 3 myalgia, local grade 3 pain, local grade 3 redness, consent withdrawal, loss to follow‐up and serious AEs.

No participant had grade 3 fever, grade 3 headache and local grade 3 swelling in either of the groups.

Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo (Lal 2015)

The AEs related the comparison between adjuvanted recombinant VZV subunit zoster vaccine (not yet available) and placebo are shown below:

  • any symptom RR 2.23, 95% CI 2.15 to 2.32, RD 0.47, 95% CI 0.45 to 0.48 and NNTH 2.1, 95% CI 2.0 to 2.2 (Analysis 10.2.1);

  • any symptom grade 3 RR 5.25, 95% CI 4.42 to 6.24, RD 0.14, 95% CI 0.13 to 0.15 and NNTH 7.1, 95% CI 6.7 to 7.7 (Analysis 10.2.2);

  • any symptom grade 3 related to vaccination RR 8.37, 95% CI 6.69 to 10.47, RD 0.14, 95% CI 0.13 to 0.15 and NNTH 7.1, 95% CI 6.7 to 7.7 (Analysis 10.2.3);

  • any systemic symptom RR 2.24, 95% CI 2.13 to 2.36, RD 0.37, 95% CI 0.35 to 0.39 and NNTH 2.7, 95% CI 2.6 to 3.3 ((Analysis 10.2.4);

  • any systemic symptom grade 3 RR 4.70, 95% CI 3.83 to 5.77, RD 0.09, 95% CI 0.08 to 0.10 and NNTH 11.1, 95% CI 10.0 to 12.5 (Analysis 10.2.5);

  • myalgia RR 3.82, 95% CI 3.51 to 4.17, RD 0.34, 95% CI 0.32 to 0.36 and NNTH 2.9, 95% CI 2.8 to 3.1 (Analysis 10.2.6);

  • fatigue RR 2.76, 95% CI 2.56 to 2.97, RD 0.29, 95% CI 0.27 to 0.31 and NNTH 3.4, 95% CI 3.2 to 3.7 (Analysis 10.2.7);

  • headache RR 2.45, 95% CI 2.27 to 2.65, RD 0.23, 95% CI 0.21 to 0.25 and NNTH 4.3, 95% CI 4.0 to 4.8 (Analysis 10.2.8);

  • shivering RR 4.76, 95% CI 4.19 to 5.41, RD 0.22, 95% CI 0.21 to 0.24 and NNTH 4.5, 95% CI 4.2 to 4.8 (Analysis 10.2.9);

  • fever RR 7.12, 95% CI 5.96 to 8.50, RD 0.18, 95% CI 0.17 to 0.20 and NNTH 5.6, 95% CI 5.0 to 5.9 (Analysis 10.2.10);

  • gastrointestinal symptom RR 2.04, 95% CI 1.82 to 2.28, RD 0.09, 95% CI 0.08 to 0.11 and NNTH 11.1, 95% CI 9.1 to 12.5 (Analysis 10.2.11);

  • any local symptom RR 6.83, 95% CI 6.30 to 7.42, RD 0.70, 95% CI 0.68 to 0.71 and NNTH 1.4, 95% CI 1.4 to 1.5 (Analysis 10.2.12);

  • any local symptom grade 3 RR 26.03, 95% CI 15.83 to 42.82, RD 0.09, 95% CI 0.08 to 0.10 and NNTH 11.1, 95% CI 10 to 12.5 (Analysis 10.2.13);

  • local pain RR 7.06, 95% CI 6.49 to 7.69, RD 0.68, 95% CI 0.66 to 0.69 and NNTH 1.5, 95% CI 1.4 to 1.5 (Analysis 10.2.14);

  • local redness RR 28.17, 95% CI 21.80 to 36.40, RD 0.37, 95% CI 0.35 to 0.38 and NNTH 2.7, 95% CI 2.6 to 2.9 (Analysis 10.2.15);

  • local swelling RR 25.04, 95% CI 18.70 to 33.52, RD 0.25, 95% CI 0.24 to 0.27 and NNTH 4.0, 95% CI 3.7 to 4.2 (Analysis 10.2.16);

  • serious AEs RR 1.01, 95% CI 0.91 to 1.11 and no RD (Analysis 10.2.17);

  • with serious AEs within 30 days after vaccination RR 0.90, 95% CI 0.67 to 1.20 and no RD (Analysis 10.2.18);

  • serious AEs within 30 days after vaccination related to vaccination RR 0.33, 95% CI 0.03 to 3.21 and no RD (Analysis 10.2.19);

  • potential immune‐mediated disease RR 0.81, 95% CI 0.60 to 1.08 and no RD (Analysis 10.2.20);

  • deaths RR 0.96, 95% CI 0.78 to 1.19 and no RD (Analysis 10.2.21);

  • deaths within 30 days after vaccination RR 1.15, 95% CI 0.42 to 3.16 and no RD (Analysis 10.2.22);

  • unsolicited report of AEs RR 1.07, 95% CI 1.00 to 1.14, RD 0.02, 95% CI 0.00 to 0.04 (Analysis 10.2.23);

  • unsolicited report of AEs grade 3 RR 1.38, 95% CI 1.12 to 1.69, RD 0.01, 95% CI 0.00 to 0.02 (Analysis 10.2.24).

AEs: adverse events
CI: confidence interval
HZ: herpes zoster
NNTH: number needed to treat for an additional harmful outcome
RD: risk difference
RR: risk ratio
VZV: varicella zoster virus

Figuras y tablas -
Table 3. Adverse events of adjuvanted recombinant VZV subunit zoster vaccine
Ir a la tabla de la revisión
Table 4. Drop‐outs

Drop‐outs of all included studies

Available live attenuated VZV zoster vaccine versus placebo

The pooled data from the studies that compared zoster vaccine and placebo showed no differences in the reasons for drop‐outs (Analysis 1.4): for any reason (RR 0.99, 95% CI 0.91 to 1.08) (Analysis 1.4.1) (Mills 2010; Oxman 2005; Vermeulen 2012), for death (RR 1.01, 95% CI 0.92 to 1.11) (Analysis 1.4.2) (Mills 2010; Murray 2011; Oxman 2005), for withdrawal of consent (RR 0.87, 95% CI 0.64 to 1.19) (Analysis 1.4.3) (Murray 2011; Oxman 2005; Vermeulen 2012), for loss to follow‐up (RR 1.29, 95% CI 0.97 to 1.73) (Analysis 1.4.4) (Mills 2010; Murray 2011; Oxman 2005; Vermeulen 2012), for protocol deviation (RR 1.58, 95% CI 0.41 to 6.02) (Analysis 1.4.5) (Murray 2011; Vermeulen 2012), for clinical AE (RR 1.36, 95% CI 0.73 to 2.54) (Analysis 1.4.6) (Murray 2011; Vermeulen 2012) and for physician decision (RR 0.20, 95% CI 0.01 to 4.17) (Analysis 1.4.7) (Murray 2011). In Mills 2010, Oxman 2005 and Vermeulen 2012 consent was withdrawn after the intervention. In Murray 2011, some patients apparently withdrew consent after randomisation, but the trial authors do not describe the exact number who withdrew consent after the intervention.

The pooled data from the studies that compared zoster vaccine and placebo (Mills 2010; Murray 2011; Oxman 2005) showed no differences in the reasons for participants with no follow‐up (Analysis 1.5).

High‐potency versus low‐potency zoster vaccine: There were no differences between the groups (Analysis 2.6).

Refrigerated versus frozen zoster vaccine: There were no differences between the groups (Analysis 3.2).

Zoster vaccine IM route versus zoster vaccine SC route: There were no withdrawals due to AE in either group (Analysis 6.1.15).

2 doses of a zoster vaccine versus a single dose and also 2 doses given at different intervals: There were no differences between the groups for participants with withdrawal due to AE (Analysis 7.1.5; Analysis 7.2.5; Analysis 7.3.5) (Vesikari 2013).

Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) ‐ lower or higher volumes of adjuvants plus gE subunit VZV or unadjuvanted gE or saline injections: There were no differences between the groups for the following reasons of drop‐out: participants with consent withdrawal and participants with loss to follow‐up (Chlibek 2013).

3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline: There were no differences between groups for participants with withdrawal of consent or participants with loss to follow‐up for all comparisons provided (Chlibek 2014).

Adjuvanted recombinant VZV subunit zoster vaccine not yet available versus placebo:Lal 2015 described 3 reasons to drop‐out: did not receive vaccine according to protocol (Analysis 10.3.1), received wrong vaccine (Analysis 10.3.2) and had diagnosis of HZ less than 30 days after dose 2 (Analysis 10.3.3). For the first 2 there were no differences between the groups. The last outcome had a RR of 0.29 (95% CI 0.09 to 0.87) but no RD and we considered it as drop‐out and not an incidence outcome since it is related to participants aged > 50 years old and not with our age group of interest (participants 60 years old or more).

AE: adverse event
CI: confidence interval
HZ: herpes zoster
IM: intramuscular
RD: risk difference
RR: risk ratio
SC: subcutaneous
VZV: varicella zoster virus

Figuras y tablas -
Table 4. Drop‐outs
Ir a la tabla de la revisión
Comparison 1. Available live attenuated VZV zoster vaccine versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Incidence of herpes zoster Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 3.1 years follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 30 days of vaccination

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 42 days of vaccination

2

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 3.3 to 7.8 years after vaccination substudy

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.5 Mean 5 years follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Incidence of herpes zoster with ZBPI ADL. Severity of interference scores of 300 or greater (high score is worse) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3 Participants with AEs Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 One or more AEs

3

6986

Risk Ratio (M‐H, Fixed, 95% CI)

1.70 [1.61, 1.80]

3.2 Vaccine‐related AEs

1

209

Risk Ratio (M‐H, Fixed, 95% CI)

4.63 [2.64, 8.12]

3.3 Systemic AEs

3

6986

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.98, 1.16]

3.4 Systemic pruritus

1

209

Risk Ratio (M‐H, Fixed, 95% CI)

7.07 [0.37, 135.13]

3.5 Vaccine‐related systemic AEs

2

6777

Risk Ratio (M‐H, Fixed, 95% CI)

1.29 [1.06, 1.57]

3.6 Varicella‐like rash not at injection site (day of vaccination to day 42)

2

38755

Risk Ratio (M‐H, Fixed, 95% CI)

1.12 [0.58, 2.18]

3.7 Herpes zoster‐like rash (day of vaccination to day 42)

1

38546

Risk Ratio (M‐H, Fixed, 95% CI)

0.47 [0.27, 0.84]

3.8 Rash unrelated to herpes zoster (day of vaccination to day 42)

1

38546

Risk Ratio (M‐H, Fixed, 95% CI)

0.96 [0.86, 1.07]

3.9 ≥ 1 serious AEs regardless of type of storage of the vaccine

4

50896

Risk Ratio (M‐H, Fixed, 95% CI)

1.08 [0.96, 1.20]

3.10 Vaccine‐related serious AEs

3

50687

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.25, 4.00]

3.11 Discontinued due to vaccine‐related AEs

2

370

Risk Ratio (M‐H, Fixed, 95% CI)

5.05 [0.25, 103.88]

3.12 Hospitalised

1

6616

Risk Ratio (M‐H, Fixed, 95% CI)

1.00 [0.93, 1.07]

3.13 Hospitalisation related to herpes zoster

1

6616

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.25, 2.67]

3.14 Injection site AEs

3

6986

Risk Ratio (M‐H, Fixed, 95% CI)

2.99 [2.75, 3.26]

3.15 Erythema inoculation site

2

6825

Risk Ratio (M‐H, Fixed, 95% CI)

5.15 [4.51, 5.87]

3.16 Pain inoculation site

2

6825

Risk Ratio (M‐H, Fixed, 95% CI)

4.14 [3.67, 4.68]

3.17 Pruritus inoculation site

2

6825

Risk Ratio (M‐H, Fixed, 95% CI)

6.91 [4.87, 9.82]

3.18 Swelling inoculation site

2

6825

Risk Ratio (M‐H, Fixed, 95% CI)

5.85 [4.96, 6.91]

3.19 Warmth inoculation site

2

6825

Risk Ratio (M‐H, Fixed, 95% CI)

5.15 [2.75, 9.66]

3.20 Rash inoculation site

1

6616

Risk Ratio (M‐H, Fixed, 95% CI)

3.26 [1.31, 8.11]

3.21 Haematoma inoculation site

1

6616

Risk Ratio (M‐H, Fixed, 95% CI)

1.13 [0.76, 1.67]

3.22 Mass inoculation site

1

6616

Risk Ratio (M‐H, Fixed, 95% CI)

14.67 [3.51, 61.33]

3.23 Varicella‐like rash at injection site (day of vaccination to day 42)

1

38546

Risk Ratio (M‐H, Fixed, 95% CI)

2.86 [1.21, 6.76]

4 Drop‐outs Show forest plot

4

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

4.1 For any reason

3

38916

Risk Ratio (M‐H, Fixed, 95% CI)

0.99 [0.91, 1.08]

4.2 Death

3

50687

Risk Ratio (M‐H, Fixed, 95% CI)

1.01 [0.92, 1.11]

4.3 Withdrew consent

3

50735

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.64, 1.19]

4.4 Lost to follow‐up

3

50735

Risk Ratio (M‐H, Fixed, 95% CI)

1.29 [0.97, 1.73]

4.5 Protocol deviation

2

12189

Risk Ratio (M‐H, Fixed, 95% CI)

1.58 [0.41, 6.02]

4.6 Clinical adverse event

2

12189

Risk Ratio (M‐H, Fixed, 95% CI)

1.36 [0.73, 2.54]

4.7 Physician decision

1

11980

Risk Ratio (M‐H, Fixed, 95% CI)

0.20 [0.01, 4.17]

5 Participants with no follow‐up Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 1. Available live attenuated VZV zoster vaccine versus placebo
Ir a la tabla de la revisión
Comparison 2. Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Incidence of herpes zoster Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2 Vaccine‐related adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3 Vaccine‐related systemic adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4 Vaccine‐related serious adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 Death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 Injection site vaccine‐related adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5.1 Erythema

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 Pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 Swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 Pruritus

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 Participants with no follow‐up Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 2. Live attenuated VZV zoster vaccine higher‐potency zoster vaccine versus lower‐potency zoster vaccine
Ir a la tabla de la revisión
Comparison 3. Live attenuated VZV zoster vaccine zoster vaccine refrigerated versus zoster vaccine frozen

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with adverse effects Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 One or more adverse effects

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Vaccine‐related adverse effects

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Systemic adverse effects

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 Systemic vaccine‐related adverse effects

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.5 Serious adverse effects

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.6 Vaccine‐related serious adverse effects

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.7 Death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.8 Injection site adverse effects

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.9 Injection site vaccine‐related adverse effects

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.10 Discontinued due to any adverse effects

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.11 Discontinued due to a vaccine‐related adverse effect

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Participants with no follow‐up Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 3. Live attenuated VZV zoster vaccine zoster vaccine refrigerated versus zoster vaccine frozen
Ir a la tabla de la revisión
Comparison 4. Live attenuated VZV zoster vaccine versus inactivated zoster vaccine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Incidence of herpes zoster Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected
Figuras y tablas -
Comparison 4. Live attenuated VZV zoster vaccine versus inactivated zoster vaccine
Ir a la tabla de la revisión
Comparison 5. Live attenuated VZV zoster vaccine versus pneumo 23 vaccine

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 3200 pfu VZV/dose Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 ≥ 1 reaction injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Induration (diameter ≥ 2 cm injection site)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Pain injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 Pain (injection site, probably vaccine‐related)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.5 Redness injection site (diameter ≥ 2 cm)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.6 Pruritus injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.7 Vesicles at injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 8500 pfu VZV/dose Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 ≥ 1 reaction injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Induration (diameter ≥ 2 cm injection site)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Pain injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 Pain (injection site, probably vaccine‐related)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.5 Redness injection site (diameter ≥ 2 cm)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.6 Pruritus injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.7 Vesicle injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 41,650 pfu/dose Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 ≥ 1 reaction injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Induration (diameter ≥ 2 cm injection site)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Pain injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Pain (injection site, probably vaccine‐related)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.5 Redness injection site (diameter ≥ 2 cm)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.6 Pruritus injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.7 Vesicle injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 Duration in days of adverse effects Show forest plot

1

Mean Difference (IV, Fixed, 95% CI)

Totals not selected

4.1 Erythema

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Swelling

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 Pain

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 Rash

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.5 Pruritus

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.6 Haematoma

1

Mean Difference (IV, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 5. Live attenuated VZV zoster vaccine versus pneumo 23 vaccine
Ir a la tabla de la revisión
Comparison 6. Live attenuated VZV zoster vaccine IM route versus zoster vaccine SC route

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Participants with adverse events Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 At least one AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Vaccine‐related AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 All systemic AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 Vaccine‐related systemic AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.5 Headache considered as vaccine‐related by the investigator

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.6 Solicited injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.7 Unsolicited injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.8 Injection site erythema

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.9 Severe injection site erythema (> 10 cm)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.10 Injection site pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.11 Severe injection site pain (inability to work or usual activity)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.12 Injection site swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.13 Severe injection site swelling (> 10 cm)

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.14 Injection site pruritus

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.15 Withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 6. Live attenuated VZV zoster vaccine IM route versus zoster vaccine SC route
Ir a la tabla de la revisión
Comparison 7. Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Zoster vaccine 1 month schedule versus zoster vaccine 3 month schedule Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 Participants with AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Participants with vaccine‐related AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Participants with serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 Participants with vaccine‐related serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.5 Participants with withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.6 Participants with vaccine‐related withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.7 Participants with non‐serious vaccine‐related withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.8 Participants with systemic AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.9 Participants with vaccine‐related systemic AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.10 Participants with rash of interest non‐injection site rashes

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.11 Participants with varicella/varicella‐like rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.12 Participants with herpes zoster/zoster‐like rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.13 Participants with injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.14 Participants with solicited injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.15 Participants with unsolicited injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.16 Participants with erythema injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.17 Participants with pain injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.18 Participants with swelling injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 Zoster vaccine 1 month schedule versus zoster vaccine single dose Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 Participants with adverse events

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Participants with vaccine‐related AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Participants with serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 Participants with vaccine‐related serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.5 Participants with withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.6 Participants with vaccine‐related withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.7 Participants with non‐serious vaccine‐related withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.8 Participants with systemic AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.9 Participants with vaccine‐related systemic AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.10 Participants with rash of interest non‐injection site rashes

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.11 Participants with varicella/varicella‐like rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.12 Participants with herpes zoster/zoster‐like rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.13 Participants with injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.14 Participants with solicited injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.15 Participants with unsolicited injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.16 Participants with erythema injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.17 Participants with pain injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.18 Participants with swelling injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Zoster vaccine 3 month schedule versus zoster vaccine single dose Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Participants with AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Participants with vaccine‐related AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Participants with serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Participants with vaccine‐related serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.5 Participants with withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.6 Participants with vaccine‐related withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.7 Participants with non‐serious vaccine‐related withdrawal due to AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.8 Participants with systemic AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.9 Participants with vaccine‐related systemic AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.10 Participants with rash of interest non‐injection site rashes

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.11 Participants with varicella/varicella‐like rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.12 Participants with herpes zoster/zoster‐like rash

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.13 Participants with injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.14 Participants with solicited injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.15 Participants with unsolicited injection site reaction

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.16 Participants with erythema injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.17 Participants with pain injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.18 Participants with swelling injection site

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 7. Live attenuated VZV zoster vaccine 2 doses versus single dose and also 2 doses given at different intervals
Ir a la tabla de la revisión
Comparison 8. Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 50 μg gE/AS01E versus 50 μg gE/AS01B Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 Participants with any symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Participants with any grade 3 symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Participants with any general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 Participants with any grade 3 general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.5 Participants with fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.6 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.7 Participants with fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.8 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.9 Participants with gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.10 Participants with grade 3 gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.11 Participants with headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.12 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.13 Participants with myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.14 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.15 Participants with any local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.16 Participants with any grade 3 local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.17 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.18 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.19 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.20 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.21 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.22 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.23 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.24 Participants with lost follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.25 Participants with serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 50 μg gE/AS01E versus 50 μg gE/saline (unadjuvanted gE) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 Participants with any symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Participants with any grade 3 symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Participants with any general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 Participants with any grade 3 general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.5 Participants with fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.6 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.7 Participants with fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.8 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.9 Participants with gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.10 Participants with grade 3 gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.11 Participants with headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.12 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.13 Participants with myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.14 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.15 Participants with any local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.16 Participants with any grade 3 local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.17 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.18 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.19 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.20 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.21 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.22 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.23 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.24 Participants with lost follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.25 Participants with serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 50 μg gE/AS01B versus 50 μg gE/saline (unadjuvanted gE) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Participants with any symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Participants with any grade 3 symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Participants with any general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Participants with any grade 3 general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.5 Participants with fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.6 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.7 Participants with fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.8 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.9 Participants with gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.10 Participants with grade 3 gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.11 Participants with headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.12 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.13 Participants with myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.14 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.15 Participants with any local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.16 Participants with any grade 3 local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.17 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.18 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.19 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.20 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.21 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.22 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.23 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.24 Participants with lost follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.25 Participants with serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 50 μg gE/AS01E versus saline Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 Participants with any symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Participants with any grade 3 symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 Participants with any general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 Participants with any grade 3 general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.5 Participants with fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.6 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.7 Participants with fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.8 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.9 Participants with gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.10 Participants with grade 3 gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.11 Participants with headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.12 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.13 Participants with myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.14 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.15 Participants with any local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.16 Participants with any grade 3 local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.17 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.18 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.19 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.20 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.21 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.22 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.23 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.24 Participants with lost follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.25 Participants with serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 50 μg gE/AS01B versus saline Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5.1 Participants with any symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 Participants with any grade 3 symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 Participants with any general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 Participants with any grade 3 general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.5 Participants with fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.6 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.7 Participants with fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.8 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.9 Participants with gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.10 Participants with grade 3 gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.11 Participants with headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.12 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.13 Participants with myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.14 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.15 Participants with any local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.16 Participants with any grade 3 local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.17 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.18 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.19 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.20 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.21 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.22 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.23 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.24 Participants with lost follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.25 Participants with serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 50 μg gE/Saline (unadjuvanted) versus saline Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6.1 Participants with any symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Participants with any grade 3 symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.3 Participants with any general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.4 Participants with any grade 3 general symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.5 Participants with fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.6 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.7 Participants with fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.8 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.9 Participants with gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.10 Participants with grade 3 gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.11 Participants with headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.12 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.13 Participants with myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.14 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.15 Participants with any local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.16 Participants with any grade 3 local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.17 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.18 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.19 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.20 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.21 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.22 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.23 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.24 Participants with lost follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.25 Participants with serious AE

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 8. Adjuvanted recombinant VZV subunit zoster vaccine: lower or higher quantities of adjuvants plus gE subunit VZV versus unadjuvanted gE or saline
Ir a la tabla de la revisión
Comparison 9. Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 25 µg gE/AS01B versus 50 µg gE/AS01B Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

1.1 Participants with any fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.2 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.3 Participants with any fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.4 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.5 Participants with any headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.6 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.7 Participants with any myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.8 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.9 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.10 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.11 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.12 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.13 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.14 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.15 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.16 Participants with lost to follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

1.17 Participants with death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2 25 µg gE/AS01B versus 100 µg gE/AS01B Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 Participants with any fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Participants with any fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.5 Participants with any headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.6 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.7 Participants with any myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.8 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.9 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.10 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.11 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.12 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.13 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.14 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.15 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.16 Participants with lost to follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.17 Participants with death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 50 µg gE/AS01B versus 100 µg gE/AS01B Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Participants with any fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Participants with any fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.4 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.5 Participants with any headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.6 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.7 Participants with any myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.8 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.9 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.10 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.11 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.12 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.13 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.14 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.15 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.16 Participants with lost to follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.17 Participants with death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4 25 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

4.1 Participants with any fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.2 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.3 Participants with any fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.4 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.5 Participants with any headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.6 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.7 Participants with any myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.8 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.9 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.10 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.11 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.12 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.13 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.14 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.15 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.16 Participants with lost to follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

4.17 Participants with death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5 50 µg gE/AS01B a versus 100 µg gE/saline (unadjuvanted gE) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

5.1 Participants with any fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.2 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.3 Participants with any fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.4 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.5 Participants with any headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.6 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.7 Participants with any myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.8 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.9 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.10 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.11 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.12 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.13 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.14 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.15 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.16 Participants with lost to follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

5.17 Participants with death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6 100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

6.1 Participants with any fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.2 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.3 Participants with any fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.4 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.5 Participants with any headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.6 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.7 Participants with any myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.8 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.9 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.10 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.11 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.12 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.13 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.14 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.15 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.16 Participants with lost to follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

6.17 Participants with death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7 25 µg gE/AS01B versus saline + 100 µg gE/AS01B Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

7.1 Participants with any fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.2 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.3 Participants with any fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.4 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.5 Participants with any headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.6 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.7 Participants with any myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.8 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.9 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.10 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.11 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.12 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.13 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.14 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.15 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.16 Participants with lost to follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

7.17 Participants with death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8 50 µg gE/AS01B versus saline + 100 µg gE/AS01B Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

8.1 Participants with any fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.2 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.3 Participants with any fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.4 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.5 Participants with any headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.6 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.7 Participants with any myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.8 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.9 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.10 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.11 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.12 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.13 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.14 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.15 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.16 Participants with lost to follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

8.17 Participants with death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9 100 µg gE/AS01B versus saline + 100 µg gE/AS01B Show forest plot

1

Odds Ratio (M‐H, Fixed, 95% CI)

Totals not selected

9.1 Participants with any fatigue

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.2 Participants with grade 3 fatigue

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.3 Participants with any fever

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.4 Participants with grade 3 fever

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.5 Participants with any headache

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.6 Participants with grade 3 headache

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.7 Participants with any myalgia

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.8 Participants with grade 3 myalgia

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.9 Participants with local pain

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.10 Participants with grade 3 local pain

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.11 Participants with local redness

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.12 Participants with grade 3 local redness

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.13 Participants with local swelling

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.14 Participants with grade 3 local swelling

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.15 Participants with consent withdrawal

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.16 Participants with lost to follow‐up

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

9.17 Participants with death

1

Odds Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10 Saline + 100 µg gE/AS01B versus 100 µg gE/saline (unadjuvanted gE) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

10.1 Participants with any fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.2 Participants with grade 3 fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.3 Participants with any fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.4 Participants with grade 3 fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.5 Participants with any headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.6 Participants with grade 3 headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.7 Participants with any myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.8 Participants with grade 3 myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.9 Participants with local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.10 Participants with grade 3 local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.11 Participants with local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.12 Participants with grade 3 local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.13 Participants with local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.14 Participants with grade 3 local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.15 Participants with consent withdrawal

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.16 Participants with lost to follow‐up

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

10.17 Participants with death

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 9. Adjuvanted recombinant VZV subunit zoster vaccine: 3 groups of VZV subunit gE in 3 different quantities versus unadjuvanted gE or saline
Ir a la tabla de la revisión
Comparison 10. Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Incidence of herpes zoster 3.2 years follow‐up (≥ 60 yo) Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2 Participants with AEs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

2.1 Any symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.2 Grade 3 any symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.3 Grade 3 any symptom related to vaccination

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.4 Any systemic symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.5 Grade 3 any systemic AEs

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.6 Myalgia

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.7 Fatigue

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.8 Headache

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.9 Shivering

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.10 Fever

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.11 Gastrointestinal symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.12 Any local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.13 Grade 3 any local symptom

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.14 Local pain

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.15 Local redness

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.16 Local swelling

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.17 Serious AEs

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.18 Serious AEs within 30 days after vaccination

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.19 Serious AEs within 30 days after vaccination related to vaccination

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.20 Potential immune‐mediated disease

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.21 Deaths

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.22 Deaths within 30 days after vaccination

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.23 Unsolicited report of AEs

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

2.24 Grade 3 unsolicited report of AEs

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3 Drop‐outs Show forest plot

1

Risk Ratio (M‐H, Fixed, 95% CI)

Totals not selected

3.1 Did not receive vaccine according to protocol

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.2 Received wrong vaccine

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]

3.3 Had diagnosis of HZ < 30 days after dose 2

1

Risk Ratio (M‐H, Fixed, 95% CI)

0.0 [0.0, 0.0]
Figuras y tablas -
Comparison 10. Adjuvanted recombinant VZV subunit zoster vaccine (not yet available) versus placebo
Ir a la tabla de la revisión