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Meta-Analysis
. 2018 Feb 1;2(2):CD004879.
doi: 10.1002/14651858.CD004879.pub5.

Vaccines for preventing influenza in healthy children

Tom Jefferson  1 , Alessandro Rivetti, Carlo Di Pietrantonj, Vittorio Demicheli
Affiliations
Meta-Analysis

Vaccines for preventing influenza in healthy children

Tom Jefferson et al. Cochrane Database Syst Rev. .

Abstract

Background: The consequences of influenza in children and adults are mainly absenteeism from school and work. However, the risk of complications is greatest in children and people over 65 years of age. This is an update of a review published in 2011. Future updates of this review will be made only when new trials or vaccines become available. Observational data included in previous versions of the review have been retained for historical reasons but have not been updated because of their lack of influence on the review conclusions.

Objectives: To assess the effects (efficacy, effectiveness, and harm) of vaccines against influenza in healthy children.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (the Cochrane Library 2016, Issue 12), which includes the Cochrane Acute Respiratory Infections Group Specialised Register, MEDLINE (1966 to 31 December 2016), Embase (1974 to 31 December 2016), WHO International Clinical Trials Registry Platform (ICTRP; 1 July 2017), and ClinicalTrials.gov (1 July 2017).

Selection criteria: Randomised controlled trials comparing influenza vaccines with placebo or no intervention in naturally occurring influenza in healthy children under 16 years. Previous versions of this review included 19 cohort and 11 case-control studies. We are no longer updating the searches for these study designs but have retained the observational studies for historical purposes.

Data collection and analysis: Review authors independently assessed risk of bias and extracted data. We used GRADE to rate the certainty of evidence for the key outcomes of influenza, influenza-like illness (ILI), complications (hospitalisation, ear infection), and adverse events. Due to variation in control group risks for influenza and ILI, absolute effects are reported as the median control group risk, and numbers needed to vaccinate (NNVs) are reported accordingly. For other outcomes aggregate control group risks are used.

Main results: We included 41 clinical trials (> 200,000 children). Most of the studies were conducted in children over the age of two and compared live attenuated or inactivated vaccines with placebo or no vaccine. Studies were conducted over single influenza seasons in the USA, Western Europe, Russia, and Bangladesh between 1984 and 2013. Restricting analyses to studies at low risk of bias showed that influenza and otitis media were the only outcomes where the impact of bias was negligible. Variability in study design and reporting impeded meta-analysis of harms outcomes.Live attenuated vaccinesCompared with placebo or do nothing, live attenuated influenza vaccines probably reduce the risk of influenza infection in children aged 3 to 16 years from 18% to 4% (risk ratio (RR) 0.22, 95% confidence interval (CI) 0.11 to 0.41; 7718 children; moderate-certainty evidence), and they may reduce ILI by a smaller degree, from 17% to 12% (RR 0.69, 95% CI 0.60 to 0.80; 124,606 children; low-certainty evidence). Seven children would need to be vaccinated to prevent one case of influenza, and 20 children would need to be vaccinated to prevent one child experiencing an ILI. Acute otitis media is probably similar following vaccine or placebo during seasonal influenza, but this result comes from a single study with particularly high rates of acute otitis media (RR 0.98, 95% CI 0.95 to 1.01; moderate-certainty evidence). There was insufficient information available to determine the effect of vaccines on school absenteeism due to very low-certainty evidence from one study. Vaccinating children may lead to fewer parents taking time off work, although the CI includes no effect (RR 0.69, 95% CI 0.46 to 1.03; low-certainty evidence). Data on the most serious consequences of influenza complications leading to hospitalisation were not available. Data from four studies measuring fever following vaccination varied considerably, from 0.16% to 15% in children who had live vaccines, while in the placebo groups the proportions ranged from 0.71% to 22% (very low-certainty evidence). Data on nausea were not reported.Inactivated vaccinesCompared with placebo or no vaccination, inactivated vaccines reduce the risk of influenza in children aged 2 to 16 years from 30% to 11% (RR 0.36, 95% CI 0.28 to 0.48; 1628 children; high-certainty evidence), and they probably reduce ILI from 28% to 20% (RR 0.72, 95% CI 0.65 to 0.79; 19,044 children; moderate-certainty evidence). Five children would need to be vaccinated to prevent one case of influenza, and 12 children would need to be vaccinated to avoid one case of ILI. The risk of otitis media is probably similar between vaccinated children and unvaccinated children (31% versus 27%), although the CI does not exclude a meaningful increase in otitis media following vaccination (RR 1.15, 95% CI 0.95 to 1.40; 884 participants; moderate-certainty evidence). There was insufficient information available to determine the effect of vaccines on school absenteeism due to very low-certainty evidence from one study. We identified no data on parental working time lost, hospitalisation, fever, or nausea.We found limited evidence on secondary cases, requirement for treatment of lower respiratory tract disease, and drug prescriptions. One brand of monovalent pandemic vaccine was associated with a sudden loss of muscle tone triggered by the experience of an intense emotion (cataplexy) and a sleep disorder (narcolepsy) in children. Evidence of serious harms (such as febrile fits) was sparse.

Authors' conclusions: In children aged between 3 and 16 years, live influenza vaccines probably reduce influenza (moderate-certainty evidence) and may reduce ILI (low-certainty evidence) over a single influenza season. In this population inactivated vaccines also reduce influenza (high-certainty evidence) and may reduce ILI (low-certainty evidence). For both vaccine types, the absolute reduction in influenza and ILI varied considerably across the study populations, making it difficult to predict how these findings translate to different settings. We found very few randomised controlled trials in children under two years of age. Adverse event data were not well described in the available studies. Standardised approaches to the definition, ascertainment, and reporting of adverse events are needed. Identification of all global cases of potential harms is beyond the scope of this review.

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Conflict of interest statement

Tom Jefferson (TJ) was a recipient of a UK National Institute for Health Research grant for a Cochrane Review of neuraminidase inhibitors for influenza. In addition, TJ receives royalties from his books published by Il Pensiero Scientifico Editore, Rome and Blackwells. TJ is occasionally interviewed by market research companies about phase I or II pharmaceutical products. In 2011‐13, TJ acted as an expert witness in litigation related to the antiviral oseltamivir, in two litigation cases on potential vaccine‐related damage, and in a labour case on influenza vaccines in healthcare workers in Canada. He has acted as a consultant for Roche (1997‐99), GSK (2001‐2), Sanofi‐Synthelabo (2003), and IMS Health (2013). In 2014 he was retained as a scientific adviser to a legal team acting on oseltamivir. TJ has a potential financial conflict of interest in the drug oseltamivir. In 2014‐16, TJ was a member of three advisory boards for Boerhinger Ingelheim. He is holder of a Cochrane Methods Innovations Fund grant to develop guidance on the use of regulatory data in Cochrane Reviews. TJ was a member of an independent data monitoring committee for a Sanofi Pasteur clinical trial on an influenza vaccine. Between 1994 and 2013, TJ was the co‐ordinator of the Cochrane Vaccines Field. TJ is a cosignatory of the Nordic Cochrane Centre Complaint to the European Medicines Agency (EMA) over maladministration at the EMA in relation to the investigation of alleged harms of human papillomavirus vaccines and consequent complaints to the European Ombudsman.

Alessandro Rivetti: none known.

Carlo Di Pietrantonj: none known.

Vittorio Demicheli: none known.

Eliana Ferroni: none known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1 Live vaccine versus placebo (RCTs), Outcome 1 Influenza.
1.2
1.2. Analysis
Comparison 1 Live vaccine versus placebo (RCTs), Outcome 2 Influenza‐like illness.
1.3
1.3. Analysis
Comparison 1 Live vaccine versus placebo (RCTs), Outcome 3 Otitis media (all episodes).
1.4
1.4. Analysis
Comparison 1 Live vaccine versus placebo (RCTs), Outcome 4 School absenteeism.
1.5
1.5. Analysis
Comparison 1 Live vaccine versus placebo (RCTs), Outcome 5 Working days lost (number of events, parents).
1.6
1.6. Analysis
Comparison 1 Live vaccine versus placebo (RCTs), Outcome 6 Drug prescriptions (number of events).
1.7
1.7. Analysis
Comparison 1 Live vaccine versus placebo (RCTs), Outcome 7 Outpatients attendance for pneumonia and influenza.
1.8
1.8. Analysis
Comparison 1 Live vaccine versus placebo (RCTs), Outcome 8 Influenza‐like illness (clustering sensitivity analysis).
2.1
2.1. Analysis
Comparison 2 Inactivated vaccine versus placebo (RCTs), Outcome 1 Influenza.
2.2
2.2. Analysis
Comparison 2 Inactivated vaccine versus placebo (RCTs), Outcome 2 Influenza‐like illness.
2.3
2.3. Analysis
Comparison 2 Inactivated vaccine versus placebo (RCTs), Outcome 3 Acute otitis media.
2.4
2.4. Analysis
Comparison 2 Inactivated vaccine versus placebo (RCTs), Outcome 4 School absenteeism.
2.5
2.5. Analysis
Comparison 2 Inactivated vaccine versus placebo (RCTs), Outcome 5 Influenza‐like illness (clustering sensitivity analysis).
3.1
3.1. Analysis
Comparison 3 Live vaccine versus placebo or no intervention (RCTs by age group), Outcome 1 Influenza.
3.2
3.2. Analysis
Comparison 3 Live vaccine versus placebo or no intervention (RCTs by age group), Outcome 2 Influenza‐like illness.
4.1
4.1. Analysis
Comparison 4 Inactivated vaccine versus placebo or no intervention (RCTs by age group), Outcome 1 Influenza.
4.2
4.2. Analysis
Comparison 4 Inactivated vaccine versus placebo or no intervention (RCTs by age group), Outcome 2 Influenza‐like illness.
5.1
5.1. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 1 Influenza.
5.2
5.2. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 2 Influenza‐like illness.
5.3
5.3. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 3 Secondary cases.
5.4
5.4. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 4 School absenteeism.
5.5
5.5. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 5 Lower respiratory tract disease.
5.6
5.6. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 6 Acute otitis media.
5.7
5.7. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 7 Hospitalisation due to acute otitis media.
5.8
5.8. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 8 Consequences of acute otitis media.
5.9
5.9. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 9 Outpatients attendance for pneumonia and influenza.
5.10
5.10. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 10 Working days lost (number of events, parents of children 6 to 36 months of age).
5.11
5.11. Analysis
Comparison 5 All vaccine types versus placebo, Outcome 11 Drug prescriptions (number of events, 6 to 36 months of age).
6.1
6.1. Analysis
Comparison 6 Case‐control studies, Outcome 1 Influenza vs influenza‐like illness (crude data).
6.2
6.2. Analysis
Comparison 6 Case‐control studies, Outcome 2 Influenza vs influenza‐like illness (adj. estimates).
6.3
6.3. Analysis
Comparison 6 Case‐control studies, Outcome 3 Influenza‐like illness vs no symptoms.
7.1
7.1. Analysis
Comparison 7 Live attenuated vaccines (cohort studies by age group), Outcome 1 Influenza.
7.2
7.2. Analysis
Comparison 7 Live attenuated vaccines (cohort studies by age group), Outcome 2 Influenza‐like illness.
8.1
8.1. Analysis
Comparison 8 Inactivated vaccines (cohort studies by age group), Outcome 1 Influenza.
8.2
8.2. Analysis
Comparison 8 Inactivated vaccines (cohort studies by age group), Outcome 2 Influenza‐like illness.
8.3
8.3. Analysis
Comparison 8 Inactivated vaccines (cohort studies by age group), Outcome 3 Otitis media.
See this image and copyright information in PMC

Update of

References

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    1. Cochran LW, Black S, Klein NP, Dekker CL, Lewis E, Reingold AL. Vaccine effectiveness against laboratory‐confirmed influenza in infants: a matched case control study. Human Vaccines 2010;23(6):729‐35. - PubMed
ba Cochran 2010c {published data only}
    1. Cochran LW, Black S, Klein NP, Dekker CL, Lewis E, Reingold AL. Vaccine effectiveness against laboratory‐confirmed influenza in infants: a matched case control study. Human Vaccines 2010;23(6):729‐35. - PubMed
ba Eisenberg 2008a {published data only}
    1. Eisenberg KW, Szilagyi PG, Fairbrother G, Griffin MR, Staat M, Shone LP, et al. Vaccine effectiveness against laboratory‐confirmed influenza in children 6 to 59 months of age during the 2003‐2004 and 2004‐2005 influenza seasons. Pediatrics 2008;122(5):911‐9. - PMC - PubMed
ba Eisenberg 2008b {published data only}
    1. Eisenberg KW, Szilagyi PG, Fairbrother G, Griffin MR, Staat M, Shone LP, et al. Vaccine effectiveness against laboratory‐confirmed influenza in children 6 to 59 months of age during the 2003‐2004 and 2004‐2005 influenza seasons. Pediatrics 2008;122(5):911‐9. - PMC - PubMed
ba Gilca 2011 {published data only}
    1. Gilca R, Deceuninck G, Serres G, Boulianne N, Sauvageau C, Quach C, et al. Effectiveness of pandemic H1N1 vaccine against influenza‐related hospitalization in children. Pediatrics 2011;128(5):e1084‐91. - PubMed
ba Hirota 1992 {published data only}
    1. Hirota Y, Takeshita S, Ide S, Kataoka K, Ohkubo A, Fukuyoshi S, et al. Various factors associated with the manifestation of influenza‐like illness. International Journal of Epidemiology 1992;21(3):574‐82. - PubMed
ba Kelly 2011 {published data only}
    1. Kelly H, Jacoby P, Dixon GA, Carcione D, Williams S, Moore HC, et al. Vaccine effectiveness against laboratory‐confirmed influenza in healthy young children: a case‐control study. Pediatric Infectious Disease Journal 2011;30(2):107‐11. - PubMed
ba Kissling 2011 {published data only}
    1. Kissling E, Valenciano M, Cohen JM, Oroszi B, Barret AS, Rizzo C, et al. I‐MOVE multi‐centre case control study 2010‐11: overall and stratified estimates of influenza vaccine effectiveness in Europe. Eurosurveillance 2011;6(11):19818. - PMC - PubMed
ba Mahmud 2011 {published data only}
    1. Mahmud S, Hammond G, Elliott L, Hilderman T, Kurbis C, Caetano P, et al. Effectiveness of the pandemic H1N1 influenza vaccines against laboratory‐confirmed H1N1 infections: population‐based case‐control study. Vaccine 2011;29(45):7975‐81. - PubMed
ba Staat 2011a {published data only}
    1. Staat MA, Griffin MR, Donauer S, Edwards KM, Szilagyi PG, Weinberg GA, et al. Vaccine effectiveness for laboratory‐confirmed influenza in children 6‐59 months of age, 2005‐2007. Vaccine 2011;29(48):9005‐11. - PubMed
ba Staat 2011b {published data only}
    1. Staat MA, Griffin MR, Donauer S, Edwards KM, Szilagyi PG, Weinberg GA, et al. Vaccine effectiveness for laboratory‐confirmed influenza in children 6‐59 months of age, 2005‐2007. Vaccine 2011;29(48):9005‐11. - PubMed
ba Valenciano 2011 {published data only}
    1. Valenciano M, Kissling E, Cohen JM, Oroszi B, Barret AS, Rizzo C, et al. Estimates of pandemic influenza vaccine effectiveness in Europe, 2009‐2010: results of Influenza Monitoring Vaccine Effectiveness in Europe (I‐MOVE) multicentre case‐control study. PLoS Medicine 2011;8(1):e1000388. - PMC - PubMed
ba Van Buynder 2010 {published data only}
    1. Buynder PG, Dhaliwal JK, Buynder JL, Couturier C, Minville‐Leblanc M, Garceau R, et al. Protective effect of single‐dose adjuvanted pandemic influenza vaccine in children. Influenza and Other Respiratory Viruses 2010;4(4):171‐8. - PMC - PubMed
bb Goodman 2006 {published data only}
    1. Goodman MJ, Nordin JD, Harper P, Defor T, Zhou X. The safety of trivalent influenza vaccine among healthy children 6 to 24 months of age. Pediatrics 2006;117(5):821‐6. - PubMed
ca Allison 2006 {published data only}
    1. Allison MA, Daley MF, Crane LA, Barrow J, Beaty BL, Allred N, et al. Influenza vaccine effectiveness in healthy 6‐ to 21‐month‐old children during the 2003‐2004 season. Journal of Pediatrics 2006;149(6):755‐62. - PubMed
ca Burtseva 1991 {published data only}
    1. Burtseva EI, Obrosova‐Serova NP, Govorkova EA, Rudenko LG, Vartanian RV, Beliaev AL, et al. A comparative study of the protective properties of live recombinant and inactivated influenza vaccines made from strain A/Philippines/2/82 (H3N2) in 8‐ to 15‐year‐old children. Voprosy Virusologii 1991;36(5):375‐7. - PubMed
ca Chumakov 1987 {published data only}
    1. Bashliaeva ZA, Sumarokov AA, Nefedova LA, Iaroshevskaia II, Ozeretskovskaia NA. Basic results of a committee trial of the new vaccine Grippovac SE‐AZh. Zhurnal Mikrobiologii, Epidemiologii, i Immunobiologii 1986;2:49‐54. - PubMed
    1. Chumakov MP, Boiko VM, Malyshkina LP, Mel'nikova SK, Rodin VI. Results of coded trials of the activity of the trivalent subunit influenza vaccine Grippovak in Moscow kindergartens in December 1983 through the 1st quarter of 1984. Voprosy Virusologii 1987;32(2):175‐83. - PubMed
ca El'shina 2000 {published data only}
    1. El'shina GA, Gorbunov MA, Bektimirov TA, Lonskaia NI, Pavlova LI, Nikul'shin AA, et al. The evaluation of the reactogenicity, harmlessness and prophylactic efficacy of Grippol trivalent polymer‐subunit influenza vaccine administered to schoolchildren. Zhurnal Mikrobiologii, Epidemiologii, i Immunobiologii 2000;2:50‐4. - PubMed
ca Fujieda 2006 {published data only}
    1. Fujieda M, Maeda A, Kondo K, Kaji M, Hirota Y. Inactivated influenza vaccine effectiveness in children under 6 years of age during the 2002‐2003 season. Vaccine 2006;24(7):957‐63. - PubMed
ca Jianping 1999 {published data only}
    1. Jianping H, Xin F, Changshun L, Bo Z, Linxiu G, Wei X, et al. Assessment of effectiveness of Vaxigrip. Vaccine 1999;17(Suppl 1):57‐8. - PubMed
ca Kawai 2003 {published data only}
    1. Kawai N, Ikematsu H, Iwaki N, Satoh I, Kawashima T, Tsuchimoto T, et al. A prospective, Internet‐based study of the effectiveness and safety of influenza vaccination in the 2001‐2002 influenza season. Vaccine 2003;21(31):4507‐13. - PubMed
ca King 2006 {published data only}
    1. King JC Jr, Stoddard JJ, Gaglani MJ, Moore KA, Magder L, McClure E, et al. Effectiveness of school‐based influenza vaccination. New England Journal of Medicine 2006;355:2523‐32. - PubMed
ca Maeda 2002 {published data only}
    1. Maeda T, Shintani Y, Miyamoto H, Kawagoe H, Nakano K, Nishiyama A, et al. Prophylactic effect of inactivated influenza vaccine on young children. Pediatrics International 2002;44(1):43‐6. - PubMed
ca Maeda 2004a {published data only}
    1. Maeda T, Shintani Y, Nakano K, Terashima K, Yamada Y. Failure of inactivated influenza A vaccine to protect healthy children aged 6‐24 months. Pediatrics International 2004;46(2):122‐5. - PubMed
ca Maeda 2004b {published data only}
    1. Maeda T, Shintani Y, Nakano K, Terashima K, Yamada Y. Failure of inactivated influenza A vaccine to protect healthy children aged 6‐24 months. Pediatrics International 2004;46(2):122‐5. - PubMed
ca Maeda 2004c {published data only}
    1. Maeda T, Shintani Y, Nakano K, Terashima K, Yamada Y. Failure of inactivated influenza A vaccine to protect healthy children aged 6‐24 months. Pediatrics International 2004;46(2):122‐5. - PubMed
ca Ortqvist 2011 {published data only}
    1. Ortqvist A, Berggren I, Insulander M, Jong B, Svenungsson B. Effectiveness of an adjuvanted monovalent vaccine against the 2009 pandemic strain of influenza A (H1N1)v, in Stockholm County, Sweden. Clinical Infectious Diseases 2011;52(10):1203‐11. - PubMed
ca Ozgur 2006 {published data only}
    1. Ozgur SK, Beyazova U, Kemaloglu YK, Maral I, Sahin F, Camurdan AD, et al. Effectiveness of inactivated influenza vaccine for prevention of otitis media in children. Pediatric Infectious Disease Journal 2006;25(5):401‐4. - PubMed
ca Salleras 2006 {published data only}
    1. Salleras L, Dominguez A, Pumarola T, Prat A, Marcos MA, Garrido P, et al. Effectiveness of virosomal subunit influenza vaccine in preventing influenza‐related illnesses and its social and economic consequences in children aged 3‐14 years: a prospective cohort study. Vaccine 2006;24(44‐6):6638‐42. - PubMed
ca Slobodniuk 2002a {published data only}
    1. Slobodniuk AV, Romanenko VV, Utnitskaia OS, Motus TM, Pereverzev AV. Influence of multiplicity of immunizations of children with inactivated influenza vaccine on immune response and the effectiveness of protection. Zhurnal Mikrobiologii, Epidemiologii, i Immunobiologii 2002;4:36‐9. - PubMed
ca Slobodniuk 2002b {published data only}
    1. Slobodniuk AV, Romanenko VV, Utnitskaia OS, Motus TM, Pereverzev AV. Influence of multiplicity of immunizations of children with inactivated influenza vaccine on immune response and the effectiveness of protection. Zhurnal Mikrobiologii, Epidemiologii, i Immunobiologii 2002;4:36‐9. - PubMed
ca Slobodniuk 2002c {published data only}
    1. Slobodniuk AV, Romanenko VV, Utnitskaia OS, Motus TM, Pereverzev AV. Influence of multiplicity of immunizations of children with inactivated influenza vaccine on immune response and the effectiveness of protection. Zhurnal Mikrobiologii, Epidemiologii, i Immunobiologii 2002;4:36‐9. - PubMed
ca Vasil'eva 1982 {published data only}
    1. Vasil'eva RI, Osidak LV, Bichurina MA, Mukhina LP, Chudina LV. Evaluation of the safety, reactogenicity and antigenic activity of inactivated chromatographic influenza vaccine in school children. Zhurnal Mikrobiologii, Epidemiologii, i Immunobiologii 1982;4:96‐8. - PubMed
ca Wiggs‐Stayner 2006 {published data only}
    1. Wiggs‐Stayner KS, Purdy TR, Go GN, McLaughlin NC, Tryzynka PS, Sines JR, et al. The impact of mass school immunization on school attendance. Journal of School of Nursing 2006;22(4):219‐22. - PubMed
ca Yin 2011 {published data only}
    1. Yin JK, Lahra MM, Iskander M, Lambert SB, Heron L, Nissen MD, et al. Pilot study of influenza vaccine effectiveness in urban Australian children attending childcare. Journal of Paediatrics and Child Health 2011;47(12):857‐62. - PMC - PubMed
cb MPA 2011 {unpublished data only}
    1. MPA. Occurrence of narcolepsy with cataplexy among children and adolescents in relation to the H1N1 pandemic and Pandemrix vaccinations – results of a case inventory study by the MPA in Sweden during 2009–2010. www.lakemedelsverket.se/upload/nyheter/2011/Fallinventeringsrapport pandermrix 110630.pdf (accessed 10 January 2012).
cb Nicholls 2004 {published and unpublished data}
    1. Nicholls S, Carroll K, Crofts J, Ben‐Eliezer E, Paul J, Zambon M, et al. Outbreak of influenza A (H3N2) in a highly‐vaccinated religious community: a retrospective cohort study. Communicable Disease and Public Health 2004;7:272‐7. - PubMed
cb Ritzwoller 2005 {published data only}
    1. Ritzwoller DP, Bridges CB, Shetterly S, Yamasaki K, Kolczak M, France EK. Effectiveness of the 2003‐2004 influenza vaccine among children 6 months to 8 years of age, with 1 vs 2 doses. Pediatrics 2005;116(1):153‐9. - PubMed
cb Slepushkin 1994 {published data only}
    1. Slepushkin AN, Rudenko LG, Kendal AP, Monto AS, Beliaev AL, Burtseva EI, et al. A comparative study of live and inactivated influenza vaccines: the organization of the observation and the results of a study of their reactogenicity and immunogenicity. Voprosy Virusologii 1994;39:129‐31. - PubMed

References to studies excluded from this review

Ambrose 2011 {published data only}
    1. Ambrose CS, Yi T, Falloon J. An integrated, multi study analysis of the safety of Ann Arbor strain live attenuated influenza vaccine in children aged 2‐17 years. Influenza and Other Respiratory Viruses 2011;5(6):389‐97. - PMC - PubMed
Ambrose 2014 {published data only}
    1. Ambrose CS, Wu X, Caspard H, Belshe RB. Efficacy of live attenuated influenza vaccine against influenza illness in children as a function of illness severity. Vaccine 2014;32(43):5546‐8. - PubMed
Anderson 1992 {published data only}
    1. Anderson EL, Newman FK, Maassab HF, Belshe RB. Evaluation of a cold‐adapted influenza B/Texas/84 reassortant virus (CRB‐87) vaccine in young children. Journal of Clinical Microbiology 1992;30(9):2230‐4. - PMC - PubMed
Anonymous 2003 {published data only}
    1. FluMist: an intranasal live influenza vaccine. Medical Letter on Drugs and Therapeutics 2003;45(1163):65‐6. - PubMed
Beare 1968 {published data only}
    1. Beare AS, Hobson D, Reed SE, Tyrrell DA. A comparison of live and killed influenza‐virus vaccines. Report to the Medical Research Council's Committee on Influenza and other Respiratory Virus Vaccines. Lancet 1968;2(7565):418‐22. - PubMed
Belshe 2000b {published data only}
    1. Belshe RB, Gruber WC, Mendelman PM, Mehta HB, Mahmood K, Reisinger K, et al. Correlates of immune protection induced by live, attenuated, cold‐adapted, trivalent, intranasal influenza virus vaccine. Journal of Infectious Diseases 2000;181(3):1133‐7. - PubMed
Belshe 2000c {published data only}
    1. Belshe RB, Gruber WC. Prevention of otitis media in children with live attenuated influenza vaccine given intranasally. Pediatric Infectious Disease Journal 2000;19(Suppl 5):66‐71. - PubMed
Belshe 2008 {published data only}
    1. Belshe RB, Ambrose CS, Yi T. Safety and efficacy of live attenuated influenza vaccine in children 2‐7 years of age. Vaccine 2008;26(Suppl 4):D10‐6. - PubMed
Bergen 2004 {published data only}
    1. Bergen R, Black S, Shinefield H, Lewis E, Ray P, Hansen J, et al. Safety of cold‐adapted live attenuated influenza vaccine in a large cohort of children and adolescents. Pediatric Infectious Disease Journal 2004;23(2):138‐44. - PubMed
Betts 1977 {published data only}
    1. Betts RF, Douglas RG Jr, Roth FK, Little JW 3rd. Efficacy of live attenuated influenza A/Scotland/74 (H3N2) virus vaccine against challenge with influenza A/Victoria/3/75 (H3N2) virus. Journal of Infectious Diseases 1977;136:746‐53. - PubMed
Beutner 1976 {published data only}
    1. Beutner KR, Rizzone C, DeMello S, Ogra PL. Clinical evaluation of neuraminidase monospecific (HEqN2) recombinant influenza vaccine in children. Developments in Biological Standardization 1976;33:162‐70. - PubMed
Bichurina 1982 {published data only}
    1. Bichurina MA, Polianskaia NI, Zhebrun AB, Rozaeva NR, Mukhina LP. Preliminary results of a trial of a highly purified inactivated chromatographic influenza vaccine for children. Trudy Instituta Imeni Pastera 1982;58:14‐6. - PubMed
Block 2011 {published data only}
    1. Block SL, Yi T, Sheldon E, Dubovsky F, Falloon J. A randomized, double‐blind noninferiority study of quadrivalent live attenuated influenza vaccine in adults. Vaccine 2011;29(50):9391‐7. - PubMed
Boyce 1999 {published data only}
    1. Boyce TG, Gruber WC, Coleman‐Dockery SD, Sannella EC, Reed GW, Wolff M, et al. Mucosal immune response to trivalent live attenuated intranasal influenza vaccine in children. Vaccine 1999;18(1‐2):82‐8. - PubMed
Boyce 2000 {published data only}
    1. Boyce TG, Hsu HH, Sannella EC, Coleman‐Dockery SD, Baylis E, Zhu Y. Safety and immunogenicity of adjuvanted and unadjuvanted subunit influenza vaccines administered intranasally to healthy adults. Vaccine 2000;19(2‐3):217‐26. - PubMed
Boyer 1977 {published data only}
    1. Boyer KM, Cherry JD, Welliver RC, Deseda‐Tous J, Zahradnik JM, Dudley JP, et al. Clinical trials with inactivated monovalent (A/New Jersey/76) and bivalent (A/New Jersey/76‐A/Victoria/75) influenza vaccines in Los Angeles children. Journal of Infectious Diseases 1977;136(Suppl):661‐4. - PubMed
Cakir 2012 {published data only}
    1. Çakir BC, Beyazova U, Kemaloğlu YK, Özkan S, Gündüz B, Özdek A. Effectiveness of pandemic influenza A/H1N1 vaccine for prevention of otitis media in children. European Journal of Pediatrics 2012;171(11):1667‐71. - PubMed
Chow 1979 {published data only}
    1. Chow TC, Beutner KR, Ogra PL. Cell‐mediated immune responses to the hemagglutinin and neuraminidase antigens of influenza A virus after immunization in humans. Infection and Immunity 1979;25(1):103‐9. - PMC - PubMed
Clements 1995 {published data only}
    1. Clements DA, Langdon L, Bland C, Walter E. Influenza A vaccine decreases the incidence of otitis media in 6‐ to 30‐month‐old children in day care. Archives of Pediatric and Adolescent Medicine 1995;149(10):1113‐7. - PubMed
Coles 1992 {published data only}
    1. Coles FB, Balzano GJ, Morse DL. An outbreak of influenza A (H3N2) in a well immunized nursing home population. Journal of the American Geriatrics Society 1992;40(6):589‐92. - PubMed
Cowling 2014 {published data only}
    1. Cowling BJ, Perera RA, Fang VJ, Chan KH, Wai W, So HC, et al. Incidence of influenza virus infections in children in Hong Kong in a 3‐year randomized placebo‐controlled vaccine study, 2009‐2012. Clinical Infectious Diseases 2014;59(4):517‐24. - PubMed
Daubeney 1997 {published data only}
    1. Daubeney P, Taylor CJ, McGaw J, Brown EM, Ghosal S, Keeton BR, et al. Immunogenicity and tolerability of a trivalent influenza subunit vaccine (Influvac) in high‐risk children aged 6 months to 4 years. British Journal of Clinical Practice 1997;51(2):87‐90. - PubMed
Donatelli 1998 {published data only}
    1. Donatelli I, Zannolli R, Fuiano L, Biasio LR. Influenza vaccine in immunogenically naive healthy infants. European Journal of Pediatrics 1998;157(11):949‐50. - PubMed
Eddy 1970 {published data only}
    1. Eddy TS, Davies NA. The effect of vaccine on a closed epidemic of Hong Kong influenza. South African Medical Journal 1970;44(8):214‐6. - PubMed
Edwards 1994 {published data only}
    1. Edwards KM, Dupont WD, Westrich MK, Plummer WD Jr, Palmer PS, Wright PF. A randomized controlled trial of cold‐adapted and inactivated vaccines for the prevention of influenza A disease. Journal of Infectious Diseases 1994;169(1):68‐76. - PubMed
El'shina 1998 {published data only}
    1. El'shina GA, Gorbunov MA, Shervarli VI, Lonskaia NI, Pavlova LI, Khaitov RM, et al. Evaluation of the effectiveness of influenza trivalent polymer subunit vaccine "Grippol". Zhurnal Mikrobiologii, Epidemiologii, i Immunobiologii 1998;3:40‐3. - PubMed
Feldman 1985 {published data only}
    1. Feldman S, Wright PF, Webster RG, Roberson PK, Mahoney J, Thompson J, et al. Use of influenza A virus vaccines in seronegative children: live cold‐adapted versus inactivated whole virus. Journal of Infectious Diseases 1985;152(6):1212‐8. - PubMed
Foy 1981 {published data only}
    1. Foy HM, Cooney MK, Allan ID, Frost F, Blumhagen JM, Fox JP. Influenza B virus vaccines in children and adults: adverse reactions, immune response, and observations in the field. Journal of Infectious Diseases 1981;143(5):700‐6. - PubMed
France 2004 {published data only}
    1. France EK, Glanz JM, Xu S, Davis RL, Black SB, Shinefield HR, et al. Safety of the trivalent inactivated influenza vaccine among children: a population‐based study. Archives of Pediatric and Adolescent Medicine 2004;158:1031‐6. - PubMed
Fujieda 2008 {published data only}
    1. Fujieda M, Maeda A, Kondo K, Fukushima W, Ohfuji S, Kaji M, et al. Influenza vaccine effectiveness and confounding factors among young children. Vaccine 2008;26(50):6481‐5. - PubMed
Gaglani 2004 {published data only}
    1. Gaglani MJ, Piedra PA, Herschler GB, Griffith ME, Kozinetz CA, Riggs MW, et al. Direct and total effectiveness of the intranasal, live‐attenuated, trivalent cold‐adapted influenza virus vaccine against the 2000‐2001 influenza A(H1N1) and B epidemic in healthy children. Archives of Pediatric and Adolescent Medicine 2004;158(1):65‐73. - PubMed
Gendon 2004 {published data only}
    1. Gendon IuZ, Kaira AN, El'shina GA, Akhmadulina RR. Total immunization of children against influenza decreases morbidity in a number of diseases among elderly persons during influenza epidemic. Zhurnal Mikrobiologii, Epidemiologii, i Immunobiologii 2004;5:62‐7. - PubMed
Glezen 2001 {published data only}
    1. Glezen WP. Effectiveness of influenza vaccination of day care children in reducing influenza‐related morbidity among household contacts. Journal of Pediatrics 2001;138:782. - PubMed
Groothuis 1994 {published data only}
    1. Groothuis JR, Lehr MV, Levin MJ. Safety and immunogenicity of a purified haemagglutinin antigen in very young high‐risk children. Vaccine 1994;12(2):139‐41. - PubMed
Groothuis 1998 {published data only}
    1. Groothuis JR, King SJ, Hogerman DA, Paradiso PR, Simoes EA. Safety and immunogenicity of a purified F protein respiratory syncytial virus (PFP‐2) vaccine in seropositive children with bronchopulmonary dysplasia. Journal of Infectious Diseases 1998;177(2):467‐9. - PubMed
Gross 1977a {published data only}
    1. Gross PA. Reactogenicity and immunogenicity of bivalent influenza vaccine in one‐ and two‐dose trials in children: a summary. Journal of Infectious Diseases 1977;136(Suppl):616‐25. - PubMed
Gross 1977b {published data only}
    1. Gross PA, Ennis FA, Gaerlan PF, Denson LJ, Denning CR, Schiffman D. A controlled double‐blind comparison of reactogenicity, immunogenicity, and protective efficacy of whole‐virus and split‐product influenza vaccines in children. Journal of Infectious Diseases 1977;136(5):623‐32. - PubMed
Gross 1982 {published data only}
    1. Gross PA, Quinnan GV, Gaerlan PF, Denning CR, Davis A, Lazicki M, et al. Potential for single high‐dose influenza immunization in unprimed children. Pediatrics 1982;70(6):982‐6. - PubMed
Gruber 1993 {published data only}
    1. Gruber WC, Kirschner K, Tollefson S, Thompson J, Reed G, Edwards KM, et al. Comparison of monovalent and trivalent live attenuated influenza vaccines in young children. Journal of Infectious Diseases 1993;168(1):53‐60. - PubMed
Haba‐Rubio 2011 {published data only}
    1. Haba‐Rubio J, Rossetti AO, Tafti M, Heinzer R. Narcolepsy with cataplexy associated with H1N1 vaccination [Narcolepsie avec cataplexie a pres vaccination anti‐H1N1]. Revista de Neurologia 2011;167(8‐9):563‐6. - PubMed
Halperin 2002 {published data only}
    1. Halperin SA, Smith B, Mabrouk T, Germain M, Trepanier P, Hassell T, et al. Safety and immunogenicity of a trivalent, inactivated, mammalian cell culture‐derived influenza vaccine in healthy adults, seniors, and children. Vaccine 2002;20(7‐8):1240‐7. - PubMed
Hambidge 2006 {published data only}
    1. Hambidge SJ, Glanz JM, France EK. Safety of inactivated influenza vaccine in children 6 to 23 months old. JAMA 2006;296:1990‐7. - PubMed
Hatch 1956 {published data only}
    1. Hatch LA, Hawkins GF, McDonald JC. Influenza vaccination in a residential boys' school; report to the medical research council committee on clinical trials of influenza vaccine. British Medical Journal 1956;12(5003):1200‐2. - PMC - PubMed
Heikkinen 2003 {published data only}
    1. Heikkinen T, Ziegler T, Peltola V, Lehtinen P, Toikka P, Lintu M, et al. Incidence of influenza in Finnish children. Pediatic Infectious Disease Journal 2003;22(Suppl 10):204‐6. - PubMed
Hoskins 1973 {published data only}
    1. Hoskins TW, Davies JR, Allchin A, Miller CL, Pollock TM. Controlled trial of inactivated influenza vaccine containing the a‐Hong Kong strain during an outbreak of influenza due to the a‐England‐42‐72 strain. Lancet 1973;2(7821):116‐20. - PubMed
Hoskins 1979 {published data only}
    1. Hoskins TW, Davies JR, Smith AJ, Miller CL, Allchin A. Assessment of inactivated influenza‐A vaccine after three outbreaks of influenza A at Christ's Hospital. Lancet 1979;1(8106):33‐5. - PubMed
Howell 1964a {published data only}
    1. Howell RW, MacKenzie AB. A comparative trial of oil‐adjuvant and aqueous polyvalent influenza vaccines. British Journal of Industrial Medicine 1964;21:265‐8. - PMC - PubMed
Howell 1964b {published data only}
    1. Howell RW, Stott AN. A trial of oil‐adjuvant influenza vaccine in a non‐epidemic season. British Journal of Industrial Medicine 1964;21:259‐64. - PMC - PubMed
Hrabar 1977 {published data only}
    1. Hrabar A, Vodopija I, Andre FE, Mitchell JR, Maassab HF, Hennessy AV, et al. A placebo‐controlled dose‐response study of the reactogenicity and immunogenicity of a cold‐adapted recombinant A/Victoria/3/75 (H3N2) live influenza virus candidate vaccine in healthy volunteers. Developments in Biological Standardization 1977;39:53‐60. - PubMed
Hurwitz 2000a {published data only}
    1. Hurwitz ES, Haber M, Chang A, Shope T, Teo S, Ginsberg M, et al. Effectiveness of influenza vaccination of day care children in reducing influenza‐related morbidity among household contacts. JAMA 2000;284(13):1677‐82. - PubMed
Hurwitz 2000b {published data only}
    1. Hurwitz ES, Haber M, Chang A, Shope T, Teo ST, Giesick JS, et al. Studies of the 1996‐1997 inactivated influenza vaccine among children attending day care: immunologic response, protection against infection, and clinical effectiveness. Journal of Infectious Diseases 2000;182:1218‐21. - PubMed
Jansen 2008 {published data only}
    1. Jansen AG, Sanders EA, Hoes AW, Loon AM, Hak E. Effects of influenza plus pneumococcal conjugate vaccination versus influenza vaccination alone in preventing respiratory tract infections in children: a randomized, double‐blind, placebo‐controlled trial. Journal of Pediatrics 2008;153(6):764‐70. - PMC - PubMed
Jovanovic 1979 {published data only}
    1. Jovanovic D, Georges‐Delvaux AM, Delem A. Protective efficacy of live influenza vaccines. Its assessment in field and experimental conditions. Developments in Biological Standardization 1979;43:241‐5. - PubMed
Jurgenssen 1978 {published data only}
    1. Jurgenssen O, Moritz A, Liehl E, Bachmayer H. Vaccination of infants and schoolchildren with an influenza subunit vaccine (author's translation). Infection 1978;6(5):221‐7. - PubMed
Just 1978 {published data only}
    1. Just M, Burgin‐Wolff A, Berger‐Hernandez R, Bachlin A, Ritzel G, Moritz AJ. A/New Jersey/76 influenza vaccine trial in seronegative schoolchildren: comparison of a subunit vaccine with a whole‐virus vaccine. Medical Microbiology and Immunology 1978;164(4):277‐84. - PubMed
Karron 1995 {published data only}
    1. Karron RA, Steinhoff MC, Subbarao EK, Wilson MH, Macleod K, Clements ML, et al. Safety and immunogenicity of a cold‐adapted influenza A (H1N1) reassortant virus vaccine administered to infants less than six months of age. Pediatric Infectious Disease Journal 1995;14(1):10‐6. - PubMed
Kaufman 2000 {published data only}
    1. Kaufman Z, Cohen‐Manheim I, Green MS. Compliance with influenza vaccination in Israel in two successive winters, 1998/1999 and 1999/2000. Israel Medical Association Journal 2000;2(10):742‐5. - PubMed
King 2001 {published data only}
    1. King JC Jr, Fast PE, Zangwill KM, Weinberg GA, Wolff M, Yan L, et al. Safety, vaccine virus shedding and immunogenicity of trivalent, cold‐adapted, live attenuated influenza vaccine administered to human immunodeficiency virus‐infected and noninfected children. Pediatric Infectious Disease Journal 2001;20(12):1124‐31. - PubMed
Kissling 2011a {published data only}
    1. Kissling E, Valenciano M. Early estimates of seasonal influenza vaccine effectiveness in Europe, 2010/11: I‐MOVE, a multicentre case‐control study. Eurosurveillance 2011;16:11. - PubMed
Kramarz 2001 {published data only}
    1. Kramarz P, Destefano F, Gargiullo PM, Chen RT, Lieu TA, Davis RL, et al. Does influenza vaccination prevent asthma exacerbations in children?. Journal of Pediatrics 2001;138(3):306‐10. - PubMed
Kuno‐Sakai 1994 {published data only}
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La Montagne 1983 {published data only}
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