Abstract
BackgroundBefore 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. MethodsThis 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. ResultsOver 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). ConclusionsThe 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
Highlights
Trivalent influenza vaccines (IIV3s) containing antigens of two influenza A strains (A/H1N1, A/H3N2) and one influenza B strain are effective in protecting against influenza [1,2]
As new influenza variants arise via frequent antigenic change, the influenza strains included in IIV3s frequently change between influenza seasons, based on recommendations by the World Health Organization (WHO) [3]
A meta-analysis of 8 case-control studies with low risk of bias found that IIV3 s provided moderate cross-protection against laboratory-confirmed pandemic H1N1 influenza [19]
Summary
Trivalent influenza vaccines (IIV3s) containing antigens of two influenza A strains (A/H1N1, A/H3N2) and one influenza B strain are effective in protecting against influenza [1,2]. The 2009 H1N1 pandemic raised the question of whether existing seasonal IIV3s might provide protection against this novel influenza strain. Over the course of the pandemic, numerous observational studies of IIV3 effectiveness were conducted and yielded conflicting results [6], suggesting seasonal vaccines to be protective [7,8,9,10,11,12], ineffective [13,14,15,16,17], or even detrimental [18] against influenza due to the pandemic H1N1 strain. A meta-analysis of 8 case-control studies with low risk of bias found that IIV3 s provided moderate cross-protection against laboratory-confirmed pandemic H1N1 influenza [19]. Participants reporting an influenza-like illness during the period from 14 days after vaccination until 30 November of each study year were tested for influenza by real-time reverse transcription
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