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

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

Author Nolan, Terry Google Scholar
Roy-Ghanta, Sumita Google Scholar
Montellano, May Google Scholar
Weckx, Lily Autor UNIFESP Google Scholar
Ulloa-Gutierrez, Rolando Google Scholar
Lazcano-Ponce, Eduardo Google Scholar
Kerdpanich, Angkool Google Scholar
Palazzi Safadi, Marco Aurelio Google Scholar
Cruz-Valdez, Aurelio Google Scholar
Litao, Sandra Autor UNIFESP Google Scholar
Lim, Fong Seng Google Scholar
Mascarenas de Los Santos, Abiel Google Scholar
Rodriguez Weber, Miguel Angel Google Scholar
Tinoco, Juan-Carlos Google Scholar
Hernandez-de Mezerville, Marcela Google Scholar
Faingezicht, Idis Google Scholar
Kosuwon, Pensri Google Scholar
Lopez, Pio Google Scholar
Borja-Tabora, Charissa Google Scholar
Li, Ping Google Scholar
Durviaux, Serge Google Scholar
Fries, Louis Google Scholar
Dubin, Gary Google Scholar
Breuer, Thomas Google Scholar
Innis, Bruce L. Google Scholar
Vaughn, David W. Google Scholar
Institution Univ Melbourne
GlaxoSmithKline Vaccines
Mary Chiles Gen Hosp
De La Salle Hlth Sci Inst
Res Inst Trop Med
Universidade Federal de São Paulo (UNIFESP)
Assoc Fundo Incent Pesquisa
Inst Costarricense Invest Clin
Natl Inst Publ Hlth Mexico
Univ Autonoma Nuevo Leon
Inst Nacl Pediat Mexico
Hosp Gen Durango
Phramongkutklao Hosp
Khon Kaen Univ
Natl Healthcare Grp Polyclin
Ctr Estudios Infect Pediat
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.
Keywords H1N1
pandemic influenza vaccine
influenza virus
Language English
Sponsor GlaxoSmithKline Biologicals
Date 2014-08-15
Published in Journal of Infectious Diseases. Cary: Oxford Univ Press Inc, v. 210, n. 4, p. 545-557, 2014.
ISSN 0022-1899 (Sherpa/Romeo, impact factor)
Publisher Oxford Univ Press Inc
Extent 545-557
Access rights Open access Open Access
Type Article
Web of Science ID WOS:000340243500006

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