Title |
Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: A randomized, placebo-controlled trial
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Published in |
Vaccine, August 2016
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DOI | 10.1016/j.vaccine.2016.08.038 |
Pubmed ID | |
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 |
Abstract |
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. 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. 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). 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. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Australia | 3 | 20% |
United States | 1 | 7% |
China | 1 | 7% |
Canada | 1 | 7% |
Unknown | 9 | 60% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 13 | 87% |
Practitioners (doctors, other healthcare professionals) | 1 | 7% |
Scientists | 1 | 7% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Australia | 1 | 2% |
Unknown | 46 | 98% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 6 | 13% |
Student > Master | 4 | 9% |
Researcher | 4 | 9% |
Other | 3 | 6% |
Professor | 3 | 6% |
Other | 8 | 17% |
Unknown | 19 | 40% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 10 | 21% |
Nursing and Health Professions | 5 | 11% |
Biochemistry, Genetics and Molecular Biology | 2 | 4% |
Immunology and Microbiology | 2 | 4% |
Computer Science | 2 | 4% |
Other | 7 | 15% |
Unknown | 19 | 40% |