Vaccines for preventing influenza in people with asthma

Christopher J Cates; Brian H Rowe

doi:10.1002/14651858.CD000364.pub4

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Figure 1

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

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Figure 2

Forest plot of comparison: 1 Protection from inactivated influenza vaccine versus placebo, outcome: 1.1 Influenza‐related asthma exacerbations.

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Figure 3

Forest plot of comparison: 2 Split virus or surface antigen vaccine versus placebo (adverse events in first two weeks), outcome: 2.1 Asthma exacerbation within two weeks.

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Figure 4

Forest plot of comparison: 2 Split virus or surface antigen vaccine versus placebo (adverse events in first two weeks), outcome: 2.2 Asthma exacerbation within three days.

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Figure 5

Forest plot of comparison: 2 Split virus or surface antigen vaccine versus placebo (adverse events in first two weeks), outcome: 2.3 Asthma exacerbation within two weeks (subgrouped by previous vaccination status).

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Analysis 1.1

Comparison 1 Protection from inactivated influenza vaccine versus placebo, Outcome 1 Influenza‐related asthma exacerbations.

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Analysis 1.2

Comparison 1 Protection from inactivated influenza vaccine versus placebo, Outcome 2 Duration of influenza‐related asthma exacerbation (days).

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Analysis 1.3

Comparison 1 Protection from inactivated influenza vaccine versus placebo, Outcome 3 Severity of influenza‐related asthma exacerbation (symptom score).

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Analysis 1.4

Comparison 1 Protection from inactivated influenza vaccine versus placebo, Outcome 4 Difference in symptom score during influenza positive weeks.

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Analysis 1.5

Comparison 1 Protection from inactivated influenza vaccine versus placebo, Outcome 5 Proportion of patients with minimum important difference in total symptom score (influenza‐positive weeks).

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Comparison 1 Protection from inactivated influenza vaccine versus placebo, Outcome 6 FEV1 (% predicted) during influenza positive weeks.

Analysis 1.6

Comparison 1 Protection from inactivated influenza vaccine versus placebo, Outcome 6 FEV₁ (% predicted) during influenza positive weeks.

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Analysis 2.1

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 1 Asthma exacerbation within 2 weeks.

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Analysis 2.2

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 2 Asthma exacerbation within 3 days.

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Analysis 2.3

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 3 Asthma exacerbation within 2 weeks (subgrouped by previous vaccination status).

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Analysis 2.4

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 4 Hospital admission (0 to 14 days post vaccination).

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Analysis 2.5

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 5 Number of symptom‐free days in 2 weeks after vaccination.

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Analysis 2.6

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 6 ≥ 1 day off school or work.

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Analysis 2.7

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 7 Medical consultation (0 to 14 days after immunisation).

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Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 8 Patients at least 15% fall in FEV1 within 5 days.

Analysis 2.8

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 8 Patients at least 15% fall in FEV₁ within 5 days.

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Analysis 2.9

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 9 Fall in mean peak flow (% baseline) days 2 to 4.

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Analysis 2.10

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 10 New or increased oral corticosteroid use (0 to 14 days after immunisation).

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Analysis 2.11

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 11 Increased nebuliser usage within 3 days.

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Analysis 2.12

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 12 Increased use of rescue medication following vaccination (days 1 to 3).

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Study
Kut 1999	No significant change in PC20 following either placebo or vaccine. PC20 (SD) in the placebo group was 7.02 (9.3) before challenge and 7.3 (3.6) after 24 hours. In the vaccine group PC20 was 9.5(10.6) before vaccine and 9.8(9.3) afterwards. (P>0.05)
Reid 1998	No significant difference found in placebo group (n=5) or vaccination group (n=17) in either mean PD20 or mean FEV1 (tested by analysis of variance ANOVA). No individual patient in either group showed a change of PD20 of more than two‐fold.
Sener 1999	No significant difference between placebo and vaccine in PD20 at 2 weeks. Vaccine 2.96(SD 3.2) and placebo 2.76 (SD 2.91)

Analysis 2.13

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 13 Change in airways responsiveness.

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Study
Govaert 1992	No adverse reactions on asthma symptoms reported from any of the 14 asthmatics immunised with split‐virus vaccine or the 11 astmatics given placebo. (Communication from author)
Hahn 1980	No significant deterioration in home Peak Flow measurement in the split vaccine (25 patients), subunit vaccine (25 patients) or placebo group (16 patients) in the two weeks following vaccination. No numerical data given.
Sener 1999	No significant difference in symptom scores in the week after vaccine. Placebo mean score 4.66 (SD 7.3), vaccine mean score 4.92 (SD 7.56)
Stenius 1986	Similar in the vaccine and placebo groups. No numerical data provided.

Analysis 2.14

Comparison 2 Adverse effects of inactivated influenza vaccine versus placebo, Outcome 14 Change in asthma symptoms in the week following vaccination.

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Analysis 3.1

Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 1 Hospital admission for asthma exacerbation.

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Analysis 3.2

Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 2 Asthma exacerbations in the month after vaccination.

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Study
Miyazaki 1993	No asthma attacks were apparent following vaccination. Evaluation was made difficult by an Adenovirus outbreak during the study period. No defintion of asthma attack provided by the authors.
Tanaka 1993	No asthma attacks were observed following vaccination (20 patients given CR vaccine and 25 given placebo). No defintion of asthma attack provided by the authors.

Analysis 3.3

Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 3 Asthma exacerbations in the week following vaccination.

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Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 4 Mean FEV1 at 2 to 5 days post vaccination (% predicted).

Analysis 3.4

Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 4 Mean FEV₁ at 2 to 5 days post vaccination (% predicted).

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Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 5 Number of patients with significant fall in FEV1 (over 12% to 15% or 50 mL) on day 2 to 4.

Analysis 3.5

Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 5 Number of patients with significant fall in FEV₁ (over 12% to 15% or 50 mL) on day 2 to 4.

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Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 6 Fall in mean FEV1 (L) (day 2 to 4).

Analysis 3.6

Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 6 Fall in mean FEV₁ (L) (day 2 to 4).

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Analysis 3.7

Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 7 Number of puffs of beta_2‐agonist per day (in month following vaccination).

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Analysis 3.8

Comparison 3 Adverse effects of live attenuated vaccine (intranasal) versus placebo, Outcome 8 Morning peak flow of greater than 30% below baseline at least once in the 4 weeks after vaccination.

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Analysis 4.1

Comparison 4 Protection from live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular), Outcome 1 Difference in incidence of asthma exacerbation over total study period.

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Analysis 4.2

Comparison 4 Protection from live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular), Outcome 2 Hospitalisations due to respiratory illness.

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Analysis 4.3

Comparison 4 Protection from live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular), Outcome 3 Days off school or work (incidence rates).

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Analysis 4.4

Comparison 4 Protection from live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular), Outcome 4 Unscheduled healthcare visits (incidence rates).

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Analysis 4.5

Comparison 4 Protection from live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular), Outcome 5 Children with serious adverse events.

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Analysis 5.1

Comparison 5 Adverse effects of live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular), Outcome 1 Subjects reporting wheeze in the first 15 days.

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Analysis 5.2

Comparison 5 Adverse effects of live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular), Outcome 2 Subjects reporting runny nose or nasal congestion in the first 15 days.

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Analysis 5.3

Comparison 5 Adverse effects of live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular), Outcome 3 Subjects reporting bronchospasm as an adverse event in first 15 days.

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Analysis 5.4

Comparison 5 Adverse effects of live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular), Outcome 4 Subjects reporting rhinitis as an adverse event in the first 15 days.

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Summary of findings for the main comparison. Inactivated influenza vaccine versus placebo

Inactivated influenza vaccine versus placebo for people with asthma
Patient or population: children and adults with asthma Settings: community Intervention: inactivated influenza vaccine (intramuscular injection)
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Adverse effects of inactivated influenza vaccine versus placebo
Results from trials in children
Protection from experiencing an asthma exacerbation of any cause over the influenza season ‐ children (over 6 years of age) given inactivated influenza vaccine	90 per 100	86 per 100 (81 to 90)	See comment	696 (1 study)	⊕⊕⊕⊝ moderate¹	Risks were calculated from risk difference in a single study (at low risk of bias)
Protection from experiencing an influenza‐related asthma exacerbation over the influenza season ‐ children (over 6 years of age) given inactivated influenza vaccine	5 per 100	6 per 100 (3 to 9)	See comment	696 (1 study)	⊕⊕⊕⊝ moderate¹	Risks were calculated from risk difference in a single study (at low risk of bias)
Asthma exacerbation (adverse effects) caused by inactivated influenza vaccine, measured in the first 2 weeks following vaccination ‐ children (over 3 years of age) given inactivated influenza vaccine	33 per 100	34 per 100 (29 to 38)	See comment	712 (1 study)	⊕⊕⊕⊝ moderate^1,2	Risks were calculated from paired proportions in a single cross‐over study (at low risk of bias)
Results from trials in adults³
Protection from experiencing an asthma exacerbation of any cause over the influenza season ‐ adults given inactivated influenza vaccine	See comment	See comment	See comment	See comment	See comment	2 parallel‐group studies in adults did not contribute to this outcome due to low levels of influenza infection in the season following vaccination
Protection from experiencing an influenza‐related asthma exacerbation over the influenza season ‐ adults given inactivated influenza vaccine	See comment	See comment	See comment	See comment	See comment	2 parallel‐group studies in adults did not contribute to this outcome due to low levels of influenza infection in the season following vaccination
Asthma exacerbation (adverse effects) caused by inactivated influenza vaccine, measured in the first 2 weeks following vaccination ‐ adults given inactivated influenza vaccine	25 per 100	27 per 100 (24 to 29)	See comment	1526 (2 studies)	⊕⊕⊕⊝ moderate^2,3	Risks were calculated from pooled risk differences (from paired proportions in 2 cross‐over studies)
The basis for the assumed risk* is the mean control group risk across studies. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the reported risk difference of the intervention (and its 95% CI). CI: confidence interval.
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.
¹ Single study on children with 95% CI that included no difference between vaccination and placebo. ² 95% CI from the pooled results of two studies excluded the pre‐specified threshold of a 6% increase in the number of participants with an asthma exacerbation following influenza vaccination. ³One trial at low risk of bias and one trial at unclear risk of bias.

Summary of findings for the main comparison. Inactivated influenza vaccine versus placebo

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Comparison 1. Protection from inactivated influenza vaccine versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Influenza‐related asthma exacerbations Show forest plot	1		Risk Difference (M‐H, Fixed, 95% CI)	Totals not selected

1.1 Number of participants with influenza‐related exacerbations	1		Risk Difference (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
1.2 Number of patients with any asthma exacerbation	1		Risk Difference (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
2 Duration of influenza‐related asthma exacerbation (days) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

3 Severity of influenza‐related asthma exacerbation (symptom score) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4 Difference in symptom score during influenza positive weeks Show forest plot	1		Mean difference (Fixed, 95% CI)	Totals not selected

5 Proportion of patients with minimum important difference in total symptom score (influenza‐positive weeks) Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

6 FEV₁ (% predicted) during influenza positive weeks Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

Comparison 1. Protection from inactivated influenza vaccine versus placebo

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Comparison 2. Adverse effects of inactivated influenza vaccine versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Asthma exacerbation within 2 weeks Show forest plot	2	2238	Risk Difference (Random, 95% CI)	0.01 [‐0.01, 0.04]

1.1 Adults	2	1526	Risk Difference (Random, 95% CI)	0.02 [‐0.01, 0.05]
1.2 Children	1	712	Risk Difference (Random, 95% CI)	0.01 [‐0.04, 0.05]
2 Asthma exacerbation within 3 days Show forest plot	2	2212	Risk Difference (Random, 95% CI)	0.01 [‐0.03, 0.05]

3 Asthma exacerbation within 2 weeks (subgrouped by previous vaccination status) Show forest plot	2	2206	Risk Difference (Random, 95% CI)	0.01 [‐0.02, 0.04]

3.1 First‐time vaccinees	2	474	Risk Difference (Random, 95% CI)	0.04 [‐0.03, 0.12]
3.2 Repeat vaccinees	2	1732	Risk Difference (Random, 95% CI)	‐0.00 [‐0.02, 0.01]
4 Hospital admission (0 to 14 days post vaccination) Show forest plot	1		Risk Difference (Fixed, 95% CI)	Totals not selected

5 Number of symptom‐free days in 2 weeks after vaccination Show forest plot	1		Mean Difference (Random, 95% CI)	Totals not selected

6 ≥ 1 day off school or work Show forest plot	2	2648	Risk Difference (Random, 95% CI)	‐0.00 [‐0.02, 0.01]

7 Medical consultation (0 to 14 days after immunisation) Show forest plot	3	2894	Risk Difference (Random, 95% CI)	0.00 [‐0.01, 0.01]

8 Patients at least 15% fall in FEV₁ within 5 days Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

8.1 First dose of vaccination	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
8.2 Second dose of vaccination	1		Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
9 Fall in mean peak flow (% baseline) days 2 to 4 Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

10 New or increased oral corticosteroid use (0 to 14 days after immunisation) Show forest plot	2	2209	Risk Difference (Random, 95% CI)	0.00 [‐0.01, 0.02]

11 Increased nebuliser usage within 3 days Show forest plot	1		Risk Difference (Fixed, 95% CI)	Totals not selected

12 Increased use of rescue medication following vaccination (days 1 to 3) Show forest plot	4	2810	Risk Difference (Random, 95% CI)	‐0.00 [‐0.02, 0.01]

13 Change in airways responsiveness Show forest plot			Other data	No numeric data

14 Change in asthma symptoms in the week following vaccination Show forest plot			Other data	No numeric data

Comparison 2. Adverse effects of inactivated influenza vaccine versus placebo

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Comparison 3. Adverse effects of live attenuated vaccine (intranasal) versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Hospital admission for asthma exacerbation Show forest plot	1		Risk Difference (M‐H, Fixed, 95% CI)	Totals not selected

2 Asthma exacerbations in the month after vaccination Show forest plot	1		Risk Difference (M‐H, Fixed, 95% CI)	Totals not selected

3 Asthma exacerbations in the week following vaccination Show forest plot			Other data	No numeric data

4 Mean FEV₁ at 2 to 5 days post vaccination (% predicted) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

5 Number of patients with significant fall in FEV₁ (over 12% to 15% or 50 mL) on day 2 to 4 Show forest plot	2	65	Risk Difference (M‐H, Fixed, 95% CI)	0.01 [‐0.12, 0.15]

6 Fall in mean FEV₁ (L) (day 2 to 4) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

7 Number of puffs of beta_2‐agonist per day (in month following vaccination) Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

8 Morning peak flow of greater than 30% below baseline at least once in the 4 weeks after vaccination Show forest plot	1		Risk Difference (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 3. Adverse effects of live attenuated vaccine (intranasal) versus placebo

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Comparison 4. Protection from live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Difference in incidence of asthma exacerbation over total study period Show forest plot	1		% Rate difference (Fixed, 95% CI)	Totals not selected

2 Hospitalisations due to respiratory illness Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Days off school or work (incidence rates) Show forest plot	1		Rate Ratio (Fixed, 95% CI)	Totals not selected

4 Unscheduled healthcare visits (incidence rates) Show forest plot	1		Rate ratio (Fixed, 95% CI)	Totals not selected

5 Children with serious adverse events Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 4. Protection from live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular)

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Comparison 5. Adverse effects of live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Subjects reporting wheeze in the first 15 days Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

2 Subjects reporting runny nose or nasal congestion in the first 15 days Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

3 Subjects reporting bronchospasm as an adverse event in first 15 days Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

4 Subjects reporting rhinitis as an adverse event in the first 15 days Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Comparison 5. Adverse effects of live attenuated vaccine (intranasal) versus trivalent inactivated vaccine (intramuscular)

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