Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial

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dc.contributor.authorNolan, Terry
dc.contributor.authorRoy-Ghanta, Sumita
dc.contributor.authorMontellano, May
dc.contributor.authorWeckx, Lily [UNIFESP]
dc.contributor.authorUlloa-Gutierrez, Rolando
dc.contributor.authorLazcano-Ponce, Eduardo
dc.contributor.authorKerdpanich, Angkool
dc.contributor.authorPalazzi Safadi, Marco Aurelio
dc.contributor.authorCruz-Valdez, Aurelio
dc.contributor.authorLitao, Sandra [UNIFESP]
dc.contributor.authorLim, Fong Seng
dc.contributor.authorMascarenas de Los Santos, Abiel
dc.contributor.authorRodriguez Weber, Miguel Angel
dc.contributor.authorTinoco, Juan-Carlos
dc.contributor.authorHernandez-de Mezerville, Marcela
dc.contributor.authorFaingezicht, Idis
dc.contributor.authorKosuwon, Pensri
dc.contributor.authorLopez, Pio
dc.contributor.authorBorja-Tabora, Charissa
dc.contributor.authorLi, Ping
dc.contributor.authorDurviaux, Serge
dc.contributor.authorFries, Louis
dc.contributor.authorDubin, Gary
dc.contributor.authorBreuer, Thomas
dc.contributor.authorInnis, Bruce L.
dc.contributor.authorVaughn, David W.
dc.contributor.institutionUniv Melbourne
dc.contributor.institutionGlaxoSmithKline Vaccines
dc.contributor.institutionNovavax
dc.contributor.institutionMary Chiles Gen Hosp
dc.contributor.institutionDe La Salle Hlth Sci Inst
dc.contributor.institutionRes Inst Trop Med
dc.contributor.institutionUniversidade Federal de São Paulo (UNIFESP)
dc.contributor.institutionAssoc Fundo Incent Pesquisa
dc.contributor.institutionInst Costarricense Invest Clin
dc.contributor.institutionNatl Inst Publ Hlth Mexico
dc.contributor.institutionUniv Autonoma Nuevo Leon
dc.contributor.institutionInst Nacl Pediat Mexico
dc.contributor.institutionHosp Gen Durango
dc.contributor.institutionPhramongkutklao Hosp
dc.contributor.institutionKhon Kaen Univ
dc.contributor.institutionNatl Healthcare Grp Polyclin
dc.contributor.institutionCtr Estudios Infect Pediat
dc.date.accessioned2016-01-24T14:37:43Z
dc.date.available2016-01-24T14:37:43Z
dc.date.issued2014-08-15
dc.description.abstractBackground. the vaccine efficacy (VE) of 1 or 2 doses of AS03-adjuvanted influenza A(H1N1) vaccine relative to that of 2 doses of nonadjuvanted influenza A(H1N1) vaccine in children 6 months to <10 years of age in a multinational study conducted during 2010-2011.Methods. A total of 6145 children were randomly assigned at a ratio of 1: 1: 1 to receive 2 injections 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine at dose 1 and saline placebo at dose 2, 2 doses 21 days apart of A/California/7/2009(H1N1)-AS03 vaccine (the Ad2 group), or 2 doses 21 days apart of nonadjuvanted A/California/7/2009(H1N1) vaccine (the NAd2 group). Active surveillance for influenza-like illnesses continued from days 14 to 385. Nose and throat samples obtained during influenza-like illnesses were tested for A/California/7/2009 (H1N1), using reverse-transcriptase polymerase chain reaction. Immunogenicity, reactogenicity, and safety were assessed.Results. There were 23 cases of confirmed 2009 pandemic influenza A(H1N1) (A[H1N1]pdm09) infection for the primary relative VE analysis. the VE in the Ad2 group relative to that in the NAd2 group was 76.8% (95% confidence interval, 18.5%-93.4%). the benefit of the AS03 adjuvant was demonstrated in terms of the greater immunogenicity observed in the Ad2 group, compared with the NAd2 group.Conclusion. the 4-8-fold antigen-sparing adjuvanted pandemic influenza vaccine demonstrated superior and clinically important prevention of A(H1N1)pdm09 infection, compared with nonadjuvanted vaccine, with no observed increase in medically attended or serious adverse events. These data support the use of adjuvanted influenza vaccines during influenza pandemics.en
dc.description.affiliationUniv Melbourne, Murdoch Childrens Res Inst, Carlton, Vic 3010, Australia
dc.description.affiliationUniv Melbourne, Melbourne Sch Populat & Global Hlth, Carlton, Vic 3010, Australia
dc.description.affiliationGlaxoSmithKline Vaccines, King of Prussia, PA USA
dc.description.affiliationNovavax, Rockville, MD USA
dc.description.affiliationMary Chiles Gen Hosp, Dept Pediat, Manila, Philippines
dc.description.affiliationDe La Salle Hlth Sci Inst, Dept Pediat, Dasmarinas City, Philippines
dc.description.affiliationRes Inst Trop Med, Dept Hlth, Muntinlupa, Philippines
dc.description.affiliationUniversidade Federal de São Paulo, Dept Pediat, São Paulo, Brazil
dc.description.affiliationFac Ciencias Med Santa Casa São Paulo, Dept Pediat, São Paulo, Brazil
dc.description.affiliationAssoc Fundo Incent Pesquisa, São Paulo, Brazil
dc.description.affiliationInst Costarricense Invest Clin, San Jose, Costa Rica
dc.description.affiliationNatl Inst Publ Hlth Mexico, Cuernavaca, Morelos, Mexico
dc.description.affiliationUniv Autonoma Nuevo Leon, Serv Med, Monterrey, Mexico
dc.description.affiliationInst Nacl Pediat Mexico, Mexico City, DF, Mexico
dc.description.affiliationHosp Gen Durango, Durango, Mexico
dc.description.affiliationPhramongkutklao Hosp, Infect Dis Unit, Dept Pediat, Bangkok, Thailand
dc.description.affiliationKhon Kaen Univ, Dept Pediat, Fac Med, Khon Kaen, Thailand
dc.description.affiliationNatl Healthcare Grp Polyclin, Singapore, Singapore
dc.description.affiliationCtr Estudios Infect Pediat, Cali, Colombia
dc.description.affiliationGlaxoSmithKline Vaccines, Wavre, Belgium
dc.description.affiliationGlaxoSmithKline Vaccines, Rixensart, Belgium
dc.description.affiliationUnifespUniversidade Federal de São Paulo, Dept Pediat, São Paulo, Brazil
dc.description.sourceWeb of Science
dc.description.sponsorshipGlaxoSmithKline Biologicals
dc.format.extent545-557
dc.identifierhttp://dx.doi.org/10.1093/infdis/jiu173
dc.identifier.citationJournal of Infectious Diseases. Cary: Oxford Univ Press Inc, v. 210, n. 4, p. 545-557, 2014.
dc.identifier.doi10.1093/infdis/jiu173
dc.identifier.fileWOS000340243500006.pdf
dc.identifier.issn0022-1899
dc.identifier.urihttp://repositorio.unifesp.br/handle/11600/38091
dc.identifier.wosWOS:000340243500006
dc.language.isoeng
dc.publisherOxford Univ Press Inc
dc.relation.ispartofJournal of Infectious Diseases
dc.rightsAcesso aberto
dc.rights.licensehttp://www.oxfordjournals.org/access_purchase/self-archiving_policyb.html
dc.subjectH1N1en
dc.subjectpandemic influenza vaccineen
dc.subjectinfluenza virusen
dc.subjectChildrenen
dc.subjectefficacyen
dc.titleRelative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trialen
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