Vaccines for preventing influenza in healthy children

Tom Jefferson; Alessandro Rivetti; Carlo Di Pietrantonj; Vittorio Demicheli; Eliana Ferroni

doi:10.1002/14651858.CD004879.pub4

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Figure 1

Study flow diagram.

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Figure 2

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

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Analysis 1.1

Comparison 1 Live vaccine versus placebo or no intervention (RCTs by age group), Outcome 1 Influenza.

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Analysis 1.2

Comparison 1 Live vaccine versus placebo or no intervention (RCTs by age group), Outcome 2 Influenza‐like illness.

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Analysis 2.1

Comparison 2 Inactivated vaccine versus placebo or no intervention (RCTs by age group), Outcome 1 Influenza.

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Analysis 2.2

Comparison 2 Inactivated vaccine versus placebo or no intervention (RCTs by age group), Outcome 2 Influenza‐like illness.

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Analysis 3.1

Comparison 3 Live attenuated vaccines (cohort studies by age group), Outcome 1 Influenza.

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Analysis 3.2

Comparison 3 Live attenuated vaccines (cohort studies by age group), Outcome 2 Influenza‐like illness.

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Analysis 4.1

Comparison 4 Inactivated vaccines (cohort studies by age group), Outcome 1 Influenza.

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Analysis 4.2

Comparison 4 Inactivated vaccines (cohort studies by age group), Outcome 2 Influenza‐like illness.

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Analysis 4.3

Comparison 4 Inactivated vaccines (cohort studies by age group), Outcome 3 Otitis media.

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Analysis 5.1

Comparison 5 Live vaccine versus placebo (RCTs), Outcome 1 Influenza.

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Analysis 5.2

Comparison 5 Live vaccine versus placebo (RCTs), Outcome 2 Influenza‐like illness.

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Analysis 5.3

Comparison 5 Live vaccine versus placebo (RCTs), Outcome 3 Otitis media (all episodes).

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Analysis 5.4

Comparison 5 Live vaccine versus placebo (RCTs), Outcome 4 Working days lost (number of events, parents).

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Analysis 5.5

Comparison 5 Live vaccine versus placebo (RCTs), Outcome 5 Drug prescriptions (number of events).

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Analysis 5.6

Comparison 5 Live vaccine versus placebo (RCTs), Outcome 6 Outpatients attendance for pneumonia and influenza.

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Analysis 6.1

Comparison 6 Inactivated vaccine versus placebo (RCTs), Outcome 1 Influenza.

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Analysis 6.2

Comparison 6 Inactivated vaccine versus placebo (RCTs), Outcome 2 Influenza‐like illness.

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Analysis 7.1

Comparison 7 Case‐control studies, Outcome 1 Influenza vs influenza‐like illness (crude data).

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Analysis 7.2

Comparison 7 Case‐control studies, Outcome 2 Influenza vs influenza‐like illness (adj. estimates).

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Analysis 7.3

Comparison 7 Case‐control studies, Outcome 3 Influenza‐like illness vs no symptoms.

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Analysis 8.1

Comparison 8 Vaccine versus placebo, Outcome 1 Influenza.

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Analysis 8.2

Comparison 8 Vaccine versus placebo, Outcome 2 Influenza‐like illness.

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Analysis 8.3

Comparison 8 Vaccine versus placebo, Outcome 3 Secondary cases.

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Analysis 8.4

Comparison 8 Vaccine versus placebo, Outcome 4 School absenteeism.

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Analysis 8.5

Comparison 8 Vaccine versus placebo, Outcome 5 Lower respiratory tract disease.

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Analysis 8.6

Comparison 8 Vaccine versus placebo, Outcome 6 Acute otitis media.

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Analysis 8.7

Comparison 8 Vaccine versus placebo, Outcome 7 Hospitalisation due to acute otitis media.

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Analysis 8.8

Comparison 8 Vaccine versus placebo, Outcome 8 Consequences of acute otitis media.

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Analysis 8.9

Comparison 8 Vaccine versus placebo, Outcome 9 Outpatients attendance for pneumonia and influenza.

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Analysis 8.10

Comparison 8 Vaccine versus placebo, Outcome 10 Working days lost (number of events, parents of children 6‐36 months of age).

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Analysis 8.11

Comparison 8 Vaccine versus placebo, Outcome 11 Drug prescriptions (number of events, 6‐36 months of age).

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Table 1. Sensitivity analysis

Comparison	Vaccine type	Study type	Outcome	Age group	Without Russian studies	Datasets	All studies	Datasets
					Risk ratio (random) (95% CI)		Risk ratio (random) (95% CI)

01.01	Live	RCTs	Influenza	</= 2 years
				</= 6 years	0.15 (0.10 to 0.23)	5	0.15 (0.10 to 0.23)	5
				> 6 years	0.47 (0.23 to 0.97)	1	0.47 (0.23 to 0.97)	1
				Total	0.18 (0.11 to 0.29)	6	0.18 (0.11 to 0.29)	6

01.02	Live	RCTs	ILI	</= 2 years
				</= 6 years	0.54 (0.12 to 2.42)*	1	0.67 (0.57 to 0.77)	5
				> 6 years	0.12 (0.01 to 2.11)*	1	0.67 (0.60 to 0.74)	8
				Total	0.39 (0.10 to 1.48)*	2	0.67 (0.62 to 0.72)	13

02.01	Inactivated	RCTs	Influenza	</= 2 years	0.55 (0.18 to 1.69)	2	0.55 (0.18 to 1.69)	2
				</= 6 years	0.61 (0.34 to 1.08)	2	0.61 (0.34 to 1.08)	2
				> 6 years	0.31 (0.22 to 0.45)	3	0.31 (0.22 to 0.45)	3
				Total	0.41 (0.29 to 0.59)	7	0.41 (0.29 to 0.59)	7

02.02	Inactivated	RCTs	ILI	</= 2 years
				</= 6 years	0.39 (0.21 to 0.69)	3	0.39 (0.21 to 0.69)	3
				> 6 years	0.24 (0.08 to 0.70)+	2	0.72 (0.66 to 0.78)	4
				Total	0.34 (0.24 to 0.50)+	5	0.64 (0.54 to 0.76)	7

03.01	Live	Cohort studies	Influenza	</= 2 years
				</= 6 years
				> 6 years			0.56 (0.35 to 0.91)	1
				Total	No studies		0.56 (0.35 to 0.91)	1

03.02	Live	Cohort studies	ILI	</= 2 years
				</= 6 years
				> 6 years	0.63 (0.57 to 0.69)	1	0.63 (0.57 to 0.69)	2
				Total	0.63 (0.57 to 0.69)	1	0.63 (0.57 to 0.69)	2

04.01	Inactivated	Cohort studies	Influenza	</= 2 years	0.63 (0.27 to 1.47)	3	0.63 (0.27 to 1.47)	3
				</= 6 years	0.34 (0.13 to 0.89)	1	0.34 (0.13 to 0.89)	1
				> 6 years	0.20 (0.10 to 0.39)*	1	0.36 (0.12 to 1.11)	2
				Total	0.36 (0.19 to 0.66)	5	0.42 (0.25 to 0.73)	6

04.02	Inactivated	Cohort studies	ILI	</= 2 years
				</= 6 years	0.40 (0.13 to 1.20)	3	0.81 (0.65 to 1.01)	4
				> 6 years	0.10 (0.05 to 0.21)+	1	0.44 (0.29 to 0.68)	7
				Total	0.26 (0.07 to 0.92)+	4	0.55 (0.42 to 0.70)	11
ILI: Influenza‐like illness RCTs: randomised controlled trials *: significance change +: possible decision‐making significant change

Table 1. Sensitivity analysis

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Table 2. Risk of bias sensitivity analysis

			All datasets					Excluding studies with high risk of bias
Comparisons		Effect measure	Number of datasets	Effect estimate	LL 95% CI	UL 95% CI	Statistical significance	Number of datasets	Effect estimate*	LL 95% CI	UL 95% CI	Statistical significance	VE absolute change	Change effect measure direction	Change in statistical significance
Analysis 1.1	Influenza	Risk ratio	7	0.20	0.13	0.32	Sign	5	0.23	0.12	0.49	Sign	‐3%	Unchanged	Unchanged
Analysis 1.1.1	Under 2 years	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 1.1.2	Under 6 years	Risk ratio	6	0.18	0.11	0.29	Sign	4	0.20	0.10	0.42	Sign	‐2%	Unchanged	Unchanged
Analysis 1.1.3	Over 6 years	Risk ratio	1	0.47	0.23	0.97	Sign	1	0.47	0.23	0.97	Sign	0%	Unchanged	Unchanged
Analysis 1.2	Influenza‐like illness	Risk ratio	13	0.67	0.62	0.72	Sign	5	0.5	0.45	0.55	Sign	17%	Unchanged	Unchanged
Analysis 1.2.1	Under 2 years	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 1.2.2	Under 6 years	Risk ratio	5	0.67	0.57	0.77	Sign	2	0.48	0.44	0.54	Sign	19%	Unchanged	Unchanged
Analysis 1.2.3	Over 6 years	Risk ratio	8	0.67	0.6	0.74	Sign	3	0.55	0.4	0.76	Sign	12%	Unchanged	Unchanged
Analysis 2.1	Influenza	Risk ratio	7	0.41	0.29	0.59	Sign	7	0.41	0.29	0.59	Sign	0%	Unchanged	Unchanged
Analysis 2.1.1	Under 2 years	Risk ratio	2	0.55	0.18	1.69	No sign	2	0.55	0.18	1.69	No sign	0%	Unchanged	Unchanged
Analysis 2.1.2	Under 6 years	Risk ratio	2	0.61	0.34	1.08	No Sign	2	0.61	0.34	1.08	No Sign	0%	Unchanged	Unchanged
Analysis 2.1.3	Over 6 years	Risk ratio	3	0.31	0.22	0.45	Sign	3	0.31	0.22	0.45	Sign	0%	Unchanged	Unchanged
Analysis 2.2	Influenza‐like illness	Risk ratio	7	0.64	0.54	0.76	Sign	4	0.39	0.19	0.8	Sign	25%	Unchanged	Unchanged
Analysis 2.2.1	Under 2 years	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 2.2.2	Under 6 years	Risk ratio	3	0.39	0.21	0.69	Sign	2	0.52	0.14	1.98	No sign	‐13%	Unchanged	Changed
Analysis 2.2.3	Over 6 years	Risk ratio	4	0.72	0.66	0.78	Sign	2	0.24	0.08	0.7	Sign	48%	Unchanged	Unchanged
Analysis 3.1	Influenza	Risk ratio	1	0.56	0.35	0.91	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 3.1.1	Under 2 years	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 3.1.2	Under 6 years	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 3.1.3	Over 6 years	Risk ratio	1	0.56	0.35	0.91	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 3.2	Influenza‐like illness	Risk ratio	2	0.63	0.57	0.69	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 3.2.1	Under 2 years	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 3.2.2	Under 6 years	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 3.2.3	Over 6 years	Risk ratio	2	0.63	0.57	0.69	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 4.1	Influenza	Risk ratio	6	0.42	0.25	0.73	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 4.1.1	Under 2 years	Risk ratio	3	0.63	0.27	1.47	No sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 4.1.2	Under 6 years	Risk ratio	1	0.34	0.13	0.89	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 4.1.3	Over 6 years	Risk ratio	2	0.36	0.12	1.11	No sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 4.2	Influenza‐like illness	Risk ratio	13	0.53	0.42	0.67	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 4.2.1	Under 2 years	Risk ratio	1	0.47	0.23	0.93	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 4.2.2	Under 6 years	Risk ratio	5	0.74	0.59	0.93	Sign	1	0.98	0.94	1.03	No sign	‐24%	Unchanged	Changed
Analysis 4.2.3	Over 6 years	Risk ratio	7	0.44	0.29	0.68	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 4.3	Otitis media	Risk ratio	1	0.48	0.22	1.03	No sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 4.3.1	Children aged 6 months to 5 years	Risk ratio	1	0.48	0.22	1.03	No sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 5.1	Influenza	Risk ratio	7	0.19	0.11	0.32	Sign	5	0.21	0.09	0.48	Sign	‐2%	Unchanged	Unchanged
Analysis 5.1.1	Live attenuated vaccines (1 dose)	Risk ratio	5	0.23	0.12	0.47	Sign	3	0.38	0.2	0.75	Sign	‐11%	Unchanged	Unchanged
Analysis 5.1.2	Live attenuated vaccines (2 doses)	Risk ratio	2	0.11	0.04	0.26	Sign	2	0.11	0.04	0.26	Sign	0%	Unchanged	Unchanged
Analysis 5.2	Influenza‐like illness	Risk ratio	8	0.69	0.6	0.8	Sign	3	0.53	0.39	0.74	Sign	16%	Unchanged	Unchanged
Analysis 5.2.1	Live attenuated vaccines (1 dose)	Risk ratio	2	0.64	0.18	2.22	No sign	1	0.27	0.06	1.16	No sign	37%	Unchanged	Unchanged
Analysis 5.2.2	Live attenuated vaccines (2 doses)	Risk ratio	6	0.66	0.57	0.76	Sign	2	0.55	0.39	0.79	Sign	11%	Unchanged	Unchanged
Analysis 5.3	Otitis media (all episodes)	Risk ratio	2	0.98	0.95	1.01	No sign	1	0.98	0.95	1.01	No sign	0%	Unchanged	Unchanged
Analysis 5.4	Working days lost (number of events, parents)	Risk ratio	2	0.69	0.46	1.03	No sign	2	0.69	0.46	1.03	No sign	0%	Unchanged	Unchanged
Analysis 5.5	Drug prescriptions (number of events)	Risk ratio	1	0.99	0.87	1.12	No sign	1	0.99	0.87	1.12	No sign	0%	Unchanged	Unchanged
Analysis 5.6	Outpatients attendance for pneumonia and influenza	Risk ratio	2	0.76	0.59	0.98	Sign	2	0.76	0.59	0.98	Sign	0%	Unchanged	Unchanged
Analysis 6.1	Influenza	Risk ratio	5	0.36	0.28	0.48	Sign	5	0.36	0.28	0.48	Sign	0%	Unchanged	Unchanged
Analysis 6.1.1	Inactivated vaccines (1 dose)	Risk ratio	5	0.36	0.28	0.48	Sign	5	0.36	0.28	0.48	Sign	0%	Unchanged	Unchanged
Analysis 6.1.2	Inactivated vaccines ( 2 doses)	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 6.2	Influenza‐like illness	Risk ratio	4	0.72	0.65	0.79	Sign	2	0.35	0.15	0.81	Sign	37%	Unchanged	Unchanged
Analysis 6.2.1	Inactivated vaccines (1 dose)	Risk ratio	2	0.35	0.15	0.81	Sign	2	0.35	0.15	0.81	Sign	0%	Unchanged	Unchanged
Analysis 6.2.2	Inactivated vaccines (2 doses)	Risk ratio	2	0.72	0.69	0.76	Sign	0	0	0	0	‐‐		Unchanged	changed
Analysis 7.1	Influenza vs ILI (crude data)	Odds Ratio					‐‐					‐‐		Unchanged	Unchanged
Analysis 7.1.1	Children aged below 6 years	Odds Ratio	9	0.59	0.45	0.77	Sign	6	0.55	0.44	0.7	Sign	4%	Unchanged	Unchanged
Analysis 7.1.2	Children aged 5 to 19 years	Odds Ratio	1	0.76	0.07	8.66	No sign	1	0.76	0.07	8.66	No sign	0%	Unchanged	Unchanged
Analysis 7.2	Influenza vs ILI (adj. estimates)	Odds Ratio					‐‐					‐‐		Unchanged	Unchanged
Analysis 7.2.1	Children aged below 23 months to fully vaccinated	Odds Ratio	7	0.6	0.39	0.94	Sign	4	0.46	0.29	0.73	Sign	14%	Unchanged	Unchanged
Analysis 7.2.2	Children aged 24 to 59 months to fully vaccinated	Odds Ratio	4	0.4	0.22	0.7	Sign	4	0.4	0.22	0.7	Sign	0%	Unchanged	Unchanged
Analysis 7.2.3	Children aged 6 to 59 months to fully vaccinated	Odds Ratio	5	0.45	0.32	0.62	Sign	5	0.45	0.32	0.62	Sign	0%	Unchanged	Unchanged
Analysis 7.2.4	Children aged below 14 years old to fully vaccinated	Odds Ratio	1	0.23	0.06	0.84	Sign	1	0.23	0.06	0.84	Sign	0%	Unchanged	Unchanged
Analysis 7.3	Influenza‐like illness vs no symptoms	Odds Ratio	2	0.49	0.28	0.86	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 7.3.1	Inactivated vaccine (1 dose)	Odds Ratio	1	0.53	0.26	1.07	No sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 7.3.2	Inactivated vaccine (2 doses)	Odds Ratio	1	0.44	0.18	1.1	No sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 8.1	Influenza	Risk ratio	11	0.27	0.18	0.42	Sign	11	0.27	0.18	0.42	Sign	0%	Unchanged	Unchanged
Analysis 8.1.1	Live attenuated vaccines (1 dose)	Risk ratio	4	0.27	0.12	0.61	Sign	4	0.27	0.12	0.61	Sign	0%	Unchanged	Unchanged
Analysis 8.1.2	Live attenuated vaccines (2 doses)	Risk ratio	2	0.11	0.04	0.26	Sign	2	0.11	0.04	0.26	Sign	0%	Unchanged	Unchanged
Analysis 8.1.3	Inactivated vaccines (1 dose)	Risk ratio	5	0.36	0.28	0.48	Sign	5	0.36	0.28	0.48	Sign	0%	Unchanged	Unchanged
Analysis 8.1.4	Inactivated vaccines (2 doses)	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 8.2	Influenza‐like illness	Risk ratio	12	0.69	0.62	0.77	Sign	5	0.5	0.38	0.67	Sign	19%	Unchanged	Unchanged
Analysis 8.2.1	Live attenuated vaccines (1 dose)	Risk ratio	2	0.64	0.18	2.22	No sign	1	0.27	0.06	1.16	No sign	37%	Unchanged	Unchanged
Analysis 8.2.2	Live attenuated vaccines (2 doses)	Risk ratio	6	0.66	0.57	0.76	Sign	2	0.55	0.39	0.79	Sign	11%	Unchanged	Unchanged
Analysis 8.2.3	Inactivated vaccines (1 dose)	Risk ratio	2	0.35	0.15	0.81	Sign	2	0.35	0.15	0.81	Sign	0%	Unchanged	Unchanged
Analysis 8.2.4	Inactivated vaccines (2 doses)	Risk ratio	2	0.72	0.69	0.76	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 8.3	Secondary cases	Risk ratio	1	1.68	0.56	4.99	No sign	1	1.68	0.56	4.99	No sign	0%	Unchanged	Unchanged
Analysis 8.3.1	Live attenuated vaccines (1 dose)	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 8.3.2	Live attenuated vaccines (2 doses)	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 8.3.3	Inactivated vaccines (1 dose)	Risk ratio	1	1.68	0.56	4.99	No sign	1	1.68	0.56	4.99	No sign	0%	Unchanged	Unchanged
Analysis 8.3.4	Inactivated vaccines (2 doses)	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 8.4	School absenteeism	Risk ratio	2	0.49	0.26	0.92	Sign	2	0.49	0.26	0.92	Sign	0%	Unchanged	Unchanged
Analysis 8.4.1	Live attenuated vaccines (1 dose)	Risk ratio	1	0.51	0.22	1.19	No sign	1	0.51	0.22	1.19	No sign	0%	Unchanged	Unchanged
Analysis 8.4.2	Live attenuated vaccines (2 doses)	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 8.4.3	Inactivated vaccines (1 dose)	Risk ratio	1	0.46	0.17	1.22	No sign	1	0.46	0.17	1.22	No sign	0%	Unchanged	Unchanged
Analysis 8.4.4	Inactivated vaccines (2 doses)	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 8.5	Lower respiratory tract disease	Risk ratio	3	0.2	0.03	1.54	No sign	2	0.52	0.08	3.37	No sign	‐32%	Unchanged	Unchanged
Analysis 8.5.1	Live attenuated vaccines (1 dose)	Risk ratio	2	0.16	0.01	4.45	No sign	1	0.73	0.07	7.88	No sign	‐57%	Unchanged	Unchanged
Analysis 8.5.2	Live attenuated vaccines (2 doses)	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 8.5.3	Inactivated vaccines (1 dose)	Risk ratio	1	0.3	0.01	6.17	No sign	1	0.3	0.01	6.17	No sign	0%	Unchanged	Unchanged
Analysis 8.5.4	Inactivated vaccines (2 doses)	Risk ratio	0	0	0	0	‐‐	0	0	0	0	‐‐		Unchanged	Unchanged
Analysis 8.6	Acute otitis media	Risk ratio	7	1	0.79	1.26	No sign	5	1.03	0.91	1.17	No sign	‐3%	changed	Unchanged
Analysis 8.6.1	Live attenuated vaccines (1 dose)	Risk ratio	3	0.42	0.05	3.79	No sign	1	1.46	0.09	22.93	No sign	‐104%	changed	Unchanged
Analysis 8.6.2	Live attenuated vaccines (2 doses)	Risk ratio	1	0.98	0.95	1.01	No sign	1	0.98	0.95	1.01	No sign	0%	Unchanged	Unchanged
Analysis 8.6.3	Inactivated vaccines (1 dose)	Risk ratio	1	1.52	0.1	23.76	No sign	1	1.52	0.1	23.76	No sign	0%	Unchanged	Unchanged
Analysis 8.6.4	Inactivated vaccines (2 doses)	Risk ratio	2	1.15	0.95	1.4	No sign	2	1.15	0.95	1.4	No sign	0%	Unchanged	Unchanged
Analysis 8.7	Hospitalisation due to acute otitis media	Risk ratio					‐‐					‐‐		Unchanged	Unchanged
Analysis 8.7.1	Inactivated vaccine (2 doses)	Risk ratio	2	1.41	0.62	3.24	No sign	2	1.41	0.62	3.24	No sign	0%	Unchanged	Unchanged
Analysis 8.8	Consequences of acute otitis media	Mean Difference					‐‐					‐‐		Unchanged	Unchanged
Analysis 8.8.1	Inactivated vaccine, 2 doses visits	Mean Difference	2	‐0.02	‐0.27	0.23	No sign	2	‐0.02	‐0.27	0.23	No sign		Unchanged	Unchanged
Analysis 8.8.2	Inactivated vaccine (2 doses; courses of antibiotics	Mean Difference	2	0.13	‐0.36	0.63	No sign	2	0.13	‐0.36	0.63	No sign		Unchanged	Unchanged
Analysis 8.9	Outpatients attendance for pneumonia and influenza	Risk ratio	2	0.76	0.59	0.98	Sign	1	0.85	0.75	0.96	Sign	‐9%	Unchanged	Unchanged
Analysis 8.9.1	Live attenuated vaccine (1 dose)	Risk ratio	1	0.65	0.49	0.85	Sign	0	0	0	0	‐‐		Unchanged	Changed
Analysis 8.9.2	Live attenuated vaccine (2 doses)	Risk ratio	1	0.85	0.75	0.96	Sign	1	0.85	0.75	0.96	Sign	0%	Unchanged	Unchanged
Analysis 8.10	Working days lost (number of events, parents of children 6 to 36 months of age)	Risk ratio	2	0.69	0.46	1.03	No sign	1	0.83	0.71	0.98	Sign	‐14%	Unchanged	Changed
Analysis 8.10.1	Live attenuated vaccine	Risk ratio	2	0.69	0.46	1.03	No sign	1	0.83	0.71	0.98	Sign	‐14%	Unchanged	Changed
Analysis 8.11	Drug prescriptions (number of events, 6 to 36 months of age)	Risk ratio	1	0.99	0.87	1.12	No sign	1	0.99	0.87	1.12	No sign	0%	Unchanged	Unchanged
Analysis 8.11.1	Live attenuated vaccine	Risk ratio	1	0.99	0.87	1.12	No sign	1	0.99	0.87	1.12	No sign	0%	Unchanged	Unchanged
CI: confidence interval LL: lower limit No sign: when effect measure is not statistically significant risk ratio: effect estimate excluding high risk of bias datasets Sign: when effect measure is statistically significant UL: upper limit VE absolute change = (1‐RR)‐(1‐RR)

Table 2. Risk of bias sensitivity analysis

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Table 3. Efficacy and effectiveness data from intraepidemic and non‐typical studies

Study reference	Exclusion reason	RCT/Cohort	Vaccine	Age group	Outcome	n treatment	N treatment	n control	N control
Nicholls 2004	Cohort from community not representative of local population	Cohort	Inactive, trivalent	0 to 2 years	ILI	11	18	3	5
Nicholls 2004	Cohort from community not representative of local population	Cohort	Inactive, trivalent	3 to 4 years	ILI	10	16	0	0
Nicholls 2004	Cohort from community not representative of local population	Cohort	Inactive, trivalent	5 to 14 years	ILI	39	91	0	3

Slepushkin 1974	Intraepidemic study of orally administered vaccine as emergency prophylaxis	RCT	Live (oral) H2N2+B	1 to 3 years	Influenza or ARI >= 10 days after vaccination	187	508	271	492

Ritzwoller 2005	Intraepidemic study	Cohort	Inactive, trivalent	6 to 23 months	ILI	65	1129	124	1615

Aksenov 1971	Intraepidemic study	Cohort	Live, H2N2 +B, 3 doses 5 days apart	4 to 7 years	Morbidity due to influenza and ARI	107	760	164	594
Aksenov 1971	Intraepidemic study	Cohort	Live, H2N2 +B, 3 doses 8 to 10 days apart	4 to 7 years	Morbidity due to influenza and ARI	81	728	193	674
Aksenov 1971	Intraepidemic study	Cohort	Live, H2N2 +B, 3 doses 5 days apart	7 to 15 years	Morbidity due to influenza and ARI	143	1358	114	776
ARI: acute respiratory infection ILI: influenza‐like illness

Table 3. Efficacy and effectiveness data from intraepidemic and non‐typical studies

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Comparison 1. Live vaccine versus placebo or no intervention (RCTs by age group)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Influenza Show forest plot	6	9175	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.13, 0.32]

1.1 under 2 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 under 6 years	6	9115	Risk Ratio (M‐H, Random, 95% CI)	0.18 [0.11, 0.29]
1.3 over 6 years	1	60	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.23, 0.97]
2 Influenza‐like illness Show forest plot	8	188418	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.62, 0.72]

2.1 under 2 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 under 6 years	5	38646	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.57, 0.77]
2.3 over 6 years	8	149772	Risk Ratio (M‐H, Random, 95% CI)	0.67 [0.60, 0.74]

Comparison 1. Live vaccine versus placebo or no intervention (RCTs by age group)

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Comparison 2. Inactivated vaccine versus placebo or no intervention (RCTs by age group)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Influenza Show forest plot	5	1628	Risk Ratio (M‐H, Random, 95% CI)	0.41 [0.29, 0.59]

1.1 under 2 years	2	786	Risk Ratio (M‐H, Random, 95% CI)	0.55 [0.18, 1.69]
1.2 under 6 years	2	132	Risk Ratio (M‐H, Random, 95% CI)	0.61 [0.34, 1.08]
1.3 over 6 years	3	710	Risk Ratio (M‐H, Random, 95% CI)	0.31 [0.22, 0.45]
2 Influenza‐like illness Show forest plot	5	19388	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.54, 0.76]

2.1 under 2 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 under 6 years	3	476	Risk Ratio (M‐H, Random, 95% CI)	0.39 [0.21, 0.69]
2.3 over 6 years	4	18912	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.66, 0.78]

Comparison 2. Inactivated vaccine versus placebo or no intervention (RCTs by age group)

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Comparison 3. Live attenuated vaccines (cohort studies by age group)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Influenza Show forest plot	1	83	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.35, 0.91]

1.1 under 2 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.2 under 6 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
1.3 over 6 years	1	83	Risk Ratio (M‐H, Random, 95% CI)	0.56 [0.35, 0.91]
2 Influenza‐like illness Show forest plot	2	22077	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.57, 0.69]

2.1 under 2 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 under 6 years	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.3 over 6 years	2	22077	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.57, 0.69]

Comparison 3. Live attenuated vaccines (cohort studies by age group)

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Comparison 4. Inactivated vaccines (cohort studies by age group)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Influenza Show forest plot	6	1873	Risk Ratio (M‐H, Random, 95% CI)	0.42 [0.25, 0.73]

1.1 under 2 years	3	314	Risk Ratio (M‐H, Random, 95% CI)	0.63 [0.27, 1.47]
1.2 under 6 years	1	180	Risk Ratio (M‐H, Random, 95% CI)	0.34 [0.13, 0.89]
1.3 over 6 years	2	1379	Risk Ratio (M‐H, Random, 95% CI)	0.36 [0.12, 1.11]
2 Influenza‐like illness Show forest plot	11	11935	Risk Ratio (M‐H, Random, 95% CI)	0.53 [0.42, 0.67]

2.1 under 2 years	1	23	Risk Ratio (M‐H, Random, 95% CI)	0.47 [0.23, 0.93]
2.2 under 6 years	5	7046	Risk Ratio (M‐H, Random, 95% CI)	0.74 [0.59, 0.93]
2.3 over 6 years	7	4866	Risk Ratio (M‐H, Random, 95% CI)	0.44 [0.29, 0.68]
3 Otitis media Show forest plot	1	119	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.22, 1.03]

3.1 Children aged 6 months to 5 years	1	119	Risk Ratio (M‐H, Random, 95% CI)	0.48 [0.22, 1.03]

Comparison 4. Inactivated vaccines (cohort studies by age group)

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Comparison 5. Live vaccine versus placebo (RCTs)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Influenza Show forest plot	6	6081	Risk Ratio (M‐H, Random, 95% CI)	0.19 [0.11, 0.32]

1.1 Live attenuated vaccines (one‐dose)	5	3038	Risk Ratio (M‐H, Random, 95% CI)	0.23 [0.12, 0.47]
1.2 Live attenuated vaccines (two‐doses)	2	3043	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.04, 0.26]
2 Influenza‐like illness Show forest plot	7	124606	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.60, 0.80]

2.1 Live attenuated vaccines (one‐dose)	2	3306	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.18, 2.22]
2.2 Live attenuated vaccines (two‐doses)	6	121300	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.57, 0.76]
3 Otitis media (all episodes) Show forest plot	2	2873	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.95, 1.01]

4 Working days lost (number of events, parents) Show forest plot	2	2874	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.46, 1.03]

5 Drug prescriptions (number of events) Show forest plot	1	1784	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.87, 1.12]

6 Outpatients attendance for pneumonia and influenza Show forest plot	2	2874	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.59, 0.98]

Comparison 5. Live vaccine versus placebo (RCTs)

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Comparison 6. Inactivated vaccine versus placebo (RCTs)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Influenza Show forest plot	5	1628	Risk Ratio (M‐H, Random, 95% CI)	0.36 [0.28, 0.48]

1.1 Inactivated vaccines (one‐dose)	5	1628	Risk Ratio (M‐H, Random, 95% CI)	0.36 [0.28, 0.48]
1.2 Inactivated vaccines (two‐doses)	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Influenza‐like illness Show forest plot	4	19044	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.65, 0.79]

2.1 Inactivated vaccines (one‐dose)	2	267	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.15, 0.81]
2.2 Inactivated vaccines (two‐doses)	2	18777	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.69, 0.76]

Comparison 6. Inactivated vaccine versus placebo (RCTs)

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Comparison 7. Case‐control studies

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Influenza vs influenza‐like illness (crude data) Show forest plot	9		Odds Ratio (M‐H, Random, 95% CI)	Subtotals only

1.1 Children aged below 6	9	4949	Odds Ratio (M‐H, Random, 95% CI)	0.59 [0.45, 0.77]
1.2 Children aged between 5‐19	1	27	Odds Ratio (M‐H, Random, 95% CI)	0.76 [0.07, 8.66]
2 Influenza vs influenza‐like illness (adj. estimates) Show forest plot	9		Odds Ratio (Random, 95% CI)	Subtotals only

2.1 Children aged below 23 months ‐ fully vaccinated	7		Odds Ratio (Random, 95% CI)	0.60 [0.39, 0.94]
2.2 Children aged between 24‐59 months ‐ fully vaccinated	4		Odds Ratio (Random, 95% CI)	0.40 [0.22, 0.70]
2.3 Children aged between 6 ‐ 59 months ‐ fully vaccinated	5		Odds Ratio (Random, 95% CI)	0.45 [0.32, 0.62]
2.4 Children aged below 14 years old ‐ fully vaccinated	1		Odds Ratio (Random, 95% CI)	0.23 [0.06, 0.84]
3 Influenza‐like illness vs no symptoms Show forest plot	1	488	Odds Ratio (M‐H, Random, 95% CI)	0.49 [0.28, 0.86]

3.1 Inactivated vaccine (one‐dose)	1	244	Odds Ratio (M‐H, Random, 95% CI)	0.53 [0.26, 1.07]
3.2 Inactivated vaccine (two‐doses)	1	244	Odds Ratio (M‐H, Random, 95% CI)	0.44 [0.18, 1.10]

Comparison 7. Case‐control studies

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Comparison 8. Vaccine versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Influenza Show forest plot	8	6590	Risk Ratio (M‐H, Random, 95% CI)	0.27 [0.18, 0.42]

1.1 Live attenuated vaccines (one‐dose)	4	1919	Risk Ratio (M‐H, Random, 95% CI)	0.27 [0.12, 0.61]
1.2 Live attenuated vaccines (two‐doses)	2	3043	Risk Ratio (M‐H, Random, 95% CI)	0.11 [0.04, 0.26]
1.3 Inactivated vaccines (one‐dose)	5	1628	Risk Ratio (M‐H, Random, 95% CI)	0.36 [0.28, 0.48]
1.4 Inactivated vaccines (two‐doses)	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2 Influenza‐like illness Show forest plot	8	143650	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.62, 0.77]

2.1 Live attenuated vaccines (one‐dose)	2	3306	Risk Ratio (M‐H, Random, 95% CI)	0.64 [0.18, 2.22]
2.2 Live attenuated vaccines (two‐doses)	6	121300	Risk Ratio (M‐H, Random, 95% CI)	0.66 [0.57, 0.76]
2.3 Inactivated vaccines (one‐dose)	2	267	Risk Ratio (M‐H, Random, 95% CI)	0.35 [0.15, 0.81]
2.4 Inactivated vaccines (two‐doses)	2	18777	Risk Ratio (M‐H, Random, 95% CI)	0.72 [0.69, 0.76]
3 Secondary cases Show forest plot	1	123	Risk Ratio (M‐H, Random, 95% CI)	1.68 [0.56, 4.99]

3.1 Live attenuated vaccines (one‐dose)	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.2 Live attenuated vaccines (two‐doses)	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
3.3 Inactivated vaccines (one‐dose)	1	123	Risk Ratio (M‐H, Random, 95% CI)	1.68 [0.56, 4.99]
3.4 Inactivated vaccines (two‐doses)	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4 School absenteeism Show forest plot	1	550	Risk Ratio (M‐H, Random, 95% CI)	0.49 [0.26, 0.92]

4.1 Live attenuated vaccines (one‐dose)	1	296	Risk Ratio (M‐H, Random, 95% CI)	0.51 [0.22, 1.19]
4.2 Live attenuated vaccines (two‐doses)	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
4.3 Inactivated vaccines (one‐dose)	1	254	Risk Ratio (M‐H, Random, 95% CI)	0.46 [0.17, 1.22]
4.4 Inactivated vaccines (two‐doses)	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5 Lower respiratory tract disease Show forest plot	2	1632	Risk Ratio (M‐H, Random, 95% CI)	0.20 [0.03, 1.54]

5.1 Live attenuated vaccines (one‐dose)	2	1496	Risk Ratio (M‐H, Random, 95% CI)	0.16 [0.01, 4.45]
5.2 Live attenuated vaccines (two doses)	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
5.3 Inactivated vaccines (one‐dose)	1	136	Risk Ratio (M‐H, Random, 95% CI)	0.30 [0.01, 6.17]
5.4 Inactivated vaccines (two‐doses)	0	0	Risk Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
6 Acute otitis media Show forest plot	6	5253	Risk Ratio (M‐H, Random, 95% CI)	1.00 [0.79, 1.26]

6.1 Live attenuated vaccines (one‐dose)	3	2585	Risk Ratio (M‐H, Random, 95% CI)	0.42 [0.05, 3.79]
6.2 Live attenuated vaccines (two‐doses)	1	1784	Risk Ratio (M‐H, Random, 95% CI)	0.98 [0.95, 1.01]
6.3 Inactivated vaccines (one‐dose)	1	136	Risk Ratio (M‐H, Random, 95% CI)	1.52 [0.10, 23.76]
6.4 Inactivated vaccines (two‐doses)	2	748	Risk Ratio (M‐H, Random, 95% CI)	1.15 [0.95, 1.40]
7 Hospitalisation due to acute otitis media Show forest plot	2		Risk Ratio (M‐H, Random, 95% CI)	Subtotals only

7.1 Inactivated vaccine (two‐doses)	2	765	Risk Ratio (M‐H, Random, 95% CI)	1.41 [0.62, 3.24]
8 Consequences of acute otitis media Show forest plot	2		Mean Difference (IV, Random, 95% CI)	Subtotals only

8.1 Inactivated vaccine (two‐doses ‐ visits)	2	765	Mean Difference (IV, Random, 95% CI)	‐0.02 [‐0.27, 0.23]
8.2 Inactivated vaccine (two‐doses ‐ courses of antibiotics)	2	765	Mean Difference (IV, Random, 95% CI)	0.13 [‐0.36, 0.63]
9 Outpatients attendance for pneumonia and influenza Show forest plot	2	2874	Risk Ratio (M‐H, Random, 95% CI)	0.76 [0.59, 0.98]

9.1 Live attenuated vaccine (one‐dose)	1	1090	Risk Ratio (M‐H, Random, 95% CI)	0.65 [0.49, 0.85]
9.2 Live attenuated vaccine (two‐doses)	1	1784	Risk Ratio (M‐H, Random, 95% CI)	0.85 [0.75, 0.96]
10 Working days lost (number of events, parents of children 6‐36 months of age) Show forest plot	2	2874	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.46, 1.03]

10.1 Live attenuated vaccine	2	2874	Risk Ratio (M‐H, Random, 95% CI)	0.69 [0.46, 1.03]
11 Drug prescriptions (number of events, 6‐36 months of age) Show forest plot	1	1784	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.87, 1.12]

11.1 Live attenuated vaccine	1	1784	Risk Ratio (M‐H, Random, 95% CI)	0.99 [0.87, 1.12]

Comparison 8. Vaccine versus placebo

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