Journal of Infectious Diseases
Volume 210 Issue 4 August 15, 2014
http://jid.oxfordjournals.org/content/current

Relative Efficacy of AS03-Adjuvanted Pandemic Influenza A(H1N1) Vaccine in Children: Results of a Controlled, Randomized Efficacy Trial
Terry Nolan1,2,a, Sumita Roy-Ghanta3,a, May Montellano5, Lily Weckx8, Rolando Ulloa-Gutierrez11, Eduardo Lazcano-Ponce12, Angkool Kerdpanich16, Marco Aurélio Palazzi afadi9,10,
Aurelio Cruz-Valdez12, Sandra Litao6, Fong Seng Lim18, Abiel Mascareñas de Los Santos13, Miguel Angel Rodriguez Weber14, Juan-Carlos Tinoco15, Marcela Hernandez-de Mezerville11, Idis Faingezicht11, Pensri Kosuwon17, Pio Lopez19, Charissa Borja-Tabora7, Ping Li3, Serge Durviaux20, Louis Fries4, Gary Dubin3, Thomas Breuer20, Bruce L. Innis3 and David W. Vaughn21
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 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/CNCT00alifornia/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.
Clinical Trials Registration. NCT01051661.