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.author Nolan, Terry
dc.contributor.author Roy-Ghanta, Sumita
dc.contributor.author Montellano, May
dc.contributor.author Weckx, Lily [UNIFESP]
dc.contributor.author Ulloa-Gutierrez, Rolando
dc.contributor.author Lazcano-Ponce, Eduardo
dc.contributor.author Kerdpanich, Angkool
dc.contributor.author Palazzi Safadi, Marco Aurelio
dc.contributor.author Cruz-Valdez, Aurelio
dc.contributor.author Litao, Sandra [UNIFESP]
dc.contributor.author Lim, Fong Seng
dc.contributor.author Mascarenas de Los Santos, Abiel
dc.contributor.author Rodriguez Weber, Miguel Angel
dc.contributor.author Tinoco, Juan-Carlos
dc.contributor.author Hernandez-de Mezerville, Marcela
dc.contributor.author Faingezicht, Idis
dc.contributor.author Kosuwon, Pensri
dc.contributor.author Lopez, Pio
dc.contributor.author Borja-Tabora, Charissa
dc.contributor.author Li, Ping
dc.contributor.author Durviaux, Serge
dc.contributor.author Fries, Louis
dc.contributor.author Dubin, Gary
dc.contributor.author Breuer, Thomas
dc.contributor.author Innis, Bruce L.
dc.contributor.author Vaughn, David W.
dc.date.accessioned 2016-01-24T14:37:43Z
dc.date.available 2016-01-24T14:37:43Z
dc.date.issued 2014-08-15
dc.identifier http://dx.doi.org/10.1093/infdis/jiu173
dc.identifier.citation Journal of Infectious Diseases. Cary: Oxford Univ Press Inc, v. 210, n. 4, p. 545-557, 2014.
dc.identifier.issn 0022-1899
dc.identifier.uri http://repositorio.unifesp.br/handle/11600/38091
dc.description.abstract Background. 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.sponsorship GlaxoSmithKline Biologicals
dc.format.extent 545-557
dc.language.iso eng
dc.publisher Oxford Univ Press Inc
dc.relation.ispartof Journal of Infectious Diseases
dc.rights Acesso aberto
dc.subject H1N1 en
dc.subject pandemic influenza vaccine en
dc.subject influenza virus en
dc.subject children en
dc.subject efficacy en
dc.title Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial en
dc.type Artigo
dc.rights.license http://www.oxfordjournals.org/access_purchase/self-archiving_policyb.html
dc.contributor.institution Univ Melbourne
dc.contributor.institution GlaxoSmithKline Vaccines
dc.contributor.institution Novavax
dc.contributor.institution Mary Chiles Gen Hosp
dc.contributor.institution De La Salle Hlth Sci Inst
dc.contributor.institution Res Inst Trop Med
dc.contributor.institution Universidade Federal de São Paulo (UNIFESP)
dc.contributor.institution Assoc Fundo Incent Pesquisa
dc.contributor.institution Inst Costarricense Invest Clin
dc.contributor.institution Natl Inst Publ Hlth Mexico
dc.contributor.institution Univ Autonoma Nuevo Leon
dc.contributor.institution Inst Nacl Pediat Mexico
dc.contributor.institution Hosp Gen Durango
dc.contributor.institution Phramongkutklao Hosp
dc.contributor.institution Khon Kaen Univ
dc.contributor.institution Natl Healthcare Grp Polyclin
dc.contributor.institution Ctr Estudios Infect Pediat
dc.description.affiliation Univ Melbourne, Murdoch Childrens Res Inst, Carlton, Vic 3010, Australia
dc.description.affiliation Univ Melbourne, Melbourne Sch Populat & Global Hlth, Carlton, Vic 3010, Australia
dc.description.affiliation GlaxoSmithKline Vaccines, King of Prussia, PA USA
dc.description.affiliation Novavax, Rockville, MD USA
dc.description.affiliation Mary Chiles Gen Hosp, Dept Pediat, Manila, Philippines
dc.description.affiliation De La Salle Hlth Sci Inst, Dept Pediat, Dasmarinas City, Philippines
dc.description.affiliation Res Inst Trop Med, Dept Hlth, Muntinlupa, Philippines
dc.description.affiliation Universidade Federal de São Paulo, Dept Pediat, São Paulo, Brazil
dc.description.affiliation Fac Ciencias Med Santa Casa São Paulo, Dept Pediat, São Paulo, Brazil
dc.description.affiliation Assoc Fundo Incent Pesquisa, São Paulo, Brazil
dc.description.affiliation Inst Costarricense Invest Clin, San Jose, Costa Rica
dc.description.affiliation Natl Inst Publ Hlth Mexico, Cuernavaca, Morelos, Mexico
dc.description.affiliation Univ Autonoma Nuevo Leon, Serv Med, Monterrey, Mexico
dc.description.affiliation Inst Nacl Pediat Mexico, Mexico City, DF, Mexico
dc.description.affiliation Hosp Gen Durango, Durango, Mexico
dc.description.affiliation Phramongkutklao Hosp, Infect Dis Unit, Dept Pediat, Bangkok, Thailand
dc.description.affiliation Khon Kaen Univ, Dept Pediat, Fac Med, Khon Kaen, Thailand
dc.description.affiliation Natl Healthcare Grp Polyclin, Singapore, Singapore
dc.description.affiliation Ctr Estudios Infect Pediat, Cali, Colombia
dc.description.affiliation GlaxoSmithKline Vaccines, Wavre, Belgium
dc.description.affiliation GlaxoSmithKline Vaccines, Rixensart, Belgium
dc.description.affiliationUnifesp Universidade Federal de São Paulo, Dept Pediat, São Paulo, Brazil
dc.identifier.file WOS000340243500006.pdf
dc.identifier.doi 10.1093/infdis/jiu173
dc.description.source Web of Science
dc.identifier.wos WOS:000340243500006



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