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Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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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 Influenza vaccine versus control, Outcome 1 At least 1 episode of acute otitis media.
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Analysis 1.1

Comparison 1 Influenza vaccine versus control, Outcome 1 At least 1 episode of acute otitis media.

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Comparison 1 Influenza vaccine versus control, Outcome 2 Acute otitis media by courses.
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Analysis 1.2

Comparison 1 Influenza vaccine versus control, Outcome 2 Acute otitis media by courses.

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Comparison 1 Influenza vaccine versus control, Outcome 3 Acute otitis media by type of vaccine.
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Analysis 1.3

Comparison 1 Influenza vaccine versus control, Outcome 3 Acute otitis media by type of vaccine.

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Comparison 1 Influenza vaccine versus control, Outcome 4 Courses of antibiotics.
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Analysis 1.4

Comparison 1 Influenza vaccine versus control, Outcome 4 Courses of antibiotics.

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Comparison 1 Influenza vaccine versus control, Outcome 5 Fever.
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Analysis 1.5

Comparison 1 Influenza vaccine versus control, Outcome 5 Fever.

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Comparison 1 Influenza vaccine versus control, Outcome 6 Rhinorrhoea.
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Analysis 1.6

Comparison 1 Influenza vaccine versus control, Outcome 6 Rhinorrhoea.

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Comparison 1 Influenza vaccine versus control, Outcome 7 Pharyngitis.
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Analysis 1.7

Comparison 1 Influenza vaccine versus control, Outcome 7 Pharyngitis.

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Summary of findings for the main comparison. Influenza vaccine compared to control for preventing acute otitis media in infants and children

Influenza vaccine compared to control for preventing acute otitis media in infants and children

Patient or population: infants and children
Setting: health care and day care
Intervention: influenza vaccine
Comparison: control

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Risk with control

Risk with influenza vaccine

At least 1 episode of acute otitis media

Study population

RR 0.84
(0.69 to 1.02)

3134
(4 RCTs)

⊕⊕⊝⊝
LOW1,2

The basis for the assumed risk is the mean risk in the control group across the included studies. There was moderate unexplained inconsistency across the studies. We downgraded for inconsistency. The effect estimates were all in the same direction, but there was uncertainty in the confidence of the effect estimate.

292 per 1000

245 per 1000
(201 to 298)

Courses of antibiotics

Study population

RR 0.70
(0.59 to 0.83)

1223
(2 RCTs)

⊕⊕⊕⊝
MODERATE1

Assumed risk calculated from the mean risk across the control groups of the 2 included studies

362 per 1000

254 per 1000
(214 to 301)

Fever

Study population

RR 1.15
(1.06 to 1.24)

10,615
(7 RCTs)

⊕⊕⊝⊝
LOW1,2,4

Assumed risk calculated from the mean risk across the control groups of the 7 included studies

174 per 1000

200 per 1000
(184 to 215)

Rhinorrhoea

Study population

RR 1.17
(1.07 to 1.29)

10,563
(6 RCTs)

⊕⊕⊝⊝
LOW1,2,4

Assumed risk calculated from the mean risk across the control groups of the 6 included studies

424 per 1000

496 per 1000
(453 to 546)

Pharyngitis

Study population

RR 1.00
(0.80 to 1.25)

4429
(3 RCTs)

⊕⊕⊝⊝
LOW1,2,4

Assumed risk calculated from the mean risk across the control groups of the 3 included studies

71 per 1000

71 per 1000
(57 to 88)

*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).
CI: confidence interval; RCT: randomised controlled trial; RR: risk ratio

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: the true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: the true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: the true effect is likely to be substantially different from the estimate of the effect.

1Includes trial(s) at high risk of publication bias.
2Unexplained heterogeneity between studies.
3Data derived from a single study with uncertainty about the effect size due to poor precision.
4Includes trial(s) at high risk of attrition bias.

Figuras y tablas -
Summary of findings for the main comparison. Influenza vaccine compared to control for preventing acute otitis media in infants and children
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Comparison 1. Influenza vaccine versus control

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 At least 1 episode of acute otitis media Show forest plot

4

3134

Risk Ratio (M‐H, Random, 95% CI)

0.84 [0.69, 1.02]

2 Acute otitis media by courses Show forest plot

4

Risk Ratio (M‐H, Random, 95% CI)

Subtotals only

2.1 First course (1 or 2 doses)

4

3134

Risk Ratio (M‐H, Random, 95% CI)

0.84 [0.69, 1.02]

2.2 Second course (1 dose)

2

1447

Risk Ratio (M‐H, Random, 95% CI)

1.12 [0.94, 1.34]

3 Acute otitis media by type of vaccine Show forest plot

4

3134

Risk Ratio (M‐H, Random, 95% CI)

0.84 [0.69, 1.02]

3.1 Trivalent cold‐adapted influenza vaccine

2

2552

Risk Ratio (M‐H, Random, 95% CI)

0.83 [0.56, 1.21]

3.2 Trivalent sub virion influenza vaccine

2

582

Risk Ratio (M‐H, Random, 95% CI)

0.77 [0.48, 1.23]

4 Courses of antibiotics Show forest plot

2

1223

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.59, 0.83]

5 Fever Show forest plot

7

10615

Risk Ratio (M‐H, Random, 95% CI)

1.15 [1.06, 1.24]

6 Rhinorrhoea Show forest plot

6

10563

Risk Ratio (M‐H, Random, 95% CI)

1.17 [1.07, 1.29]

7 Pharyngitis Show forest plot

3

4429

Risk Ratio (M‐H, Random, 95% CI)

1.00 [0.80, 1.25]
Figuras y tablas -
Comparison 1. Influenza vaccine versus control
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