Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: A randomized, placebo-controlled trial
Year: 2016
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: BACKGROUND: Before pandemic H1N1 vaccines were available, the potential benefit of existing seasonal trivalent inactivated influenza vaccines (IIV3s) against influenza due to the 2009 pandemic H1N1 influenza strain was investigated, with conflicting results. This study assessed the efficacy of seasonal IIV3s against influenza due to 2008 and 2009 seasonal influenza strains and against the 2009 pandemic H1N1 strain. METHODS: This observer-blind, randomized, placebo-controlled study enrolled adults aged 18-64years during 2008 and 2009 in Australia and New Zealand. Participants were randomized 2:1 to receive IIV3 or placebo. The primary objective was to demonstrate the efficacy of IIV3 against laboratory-confirmed influenza. Participants reporting an influenza-like illness during the period from 14days after vaccination until 30 November of each study year were tested for influenza by real-time reverse transcription polymerase chain reaction. RESULTS: Over a study period of 2years, 15,044 participants were enrolled (mean age±standard deviation: 35.5±14.7years; 54.4% female). Vaccine efficacy of the 2008 and 2009 IIV3s against influenza due to any strain was 42% (95% confidence interval [CI]: 30%, 52%), whereas vaccine efficacy against influenza due to the vaccine-matched strains was 60% (95% CI: 44%, 72%). Vaccine efficacy of the 2009 IIV3 against influenza due to the 2009 pandemic H1N1 strain was 38% (95% CI: 19%, 53%). No vaccine-related deaths or serious adverse events were reported. Solicited local and systemic adverse events were more frequent in IIV3 recipients than placebo recipients (local: IIV3 74.6% vs placebo 20.4%, p<0.001; systemic: IIV3 46.6% vs placebo 39.1%, p<0.001). CONCLUSIONS: The 2008 and 2009 IIV3s were efficacious against influenza due to seasonal influenza strains and the 2009 IIV3 demonstrated moderate efficacy against influenza due to the 2009 pandemic H1N1 strain. Funded by CSL Limited, ClinicalTrials.gov identifier NCT00562484.
Source: Vaccine
Authors: William J.H. Mcbride, Walter P. Abhayaratna, Ian Barr, Robert Booy, Jonathan Carapetis, Simon Carson, Ferdinandus De Looze, Rod Ellis-Pegler, Leon Heron, Jeff Karrasch, Helen Marshall, Jodie Mcvernon, Terry Nolan, William Rawlinson, Jim Reid, Peter Richmond, Sepehr Shakib, Russell L. Basser, Gunter F. Hartel, Michael H. Lai, Steven Rockman, Michael E. Greenberg
Institutions: Cairns Hospital, James Cook University, Australian National University, Canberra Hospital, World Health Organization, The University of Sydney, Children's Hospital at Westmead, Charles Darwin University, Menzies School of Health Research, The University of Queensland, Redcliffe Hospital, Women's and Children's Hospital, Women's and Children's Health Network, The University of Adelaide, The University of Melbourne, Murdoch Children's Research Institute, UNSW Sydney, University of Otago, The University of Western Australia, Princess Margaret Hospital for Children, CSL (Australia)
Language: English
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,620
OpenAlex ID: W2511965332