Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: a randomized, placebo-controlled trial

McBride, William J.H., Abhayaratna, Walter P., Barr, Ian, Booy, Robert, Carapetis, Jonathan, Carson, Simon, De Looze, Ferdinandus, Ellis-Pegler, Rod, Heron, Leon, Karrasch, Jeff, Marshall, Helen, Mcvernon, Jodie, Nolan, Terry, Rawlinson, William, Reid, Jim, Richmond, Peter, Shakib, Sepehr, Basser, Russell, Hartel, Gunter F., Lai, Michael H., Rockman, Steven, and Greenberg, Michael E. (2016) Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: a randomized, placebo-controlled trial. Vaccine, 34 (41). pp. 4991-4997.

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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 18–64 years 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 14 days 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 2 years, 15,044 participants were enrolled (mean age ± standard deviation: 35.5 ± 14.7 years; 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.

Item ID: 46013
Item Type: Article (Research - C1)
ISSN: 1873-2518
Keywords: cross-protection; Influenza A virus; H1N1 subtype; Influenza vaccine efficacy; seasonal influenza; seasonal trivalent inactivated influenza vaccine
Additional Information:

© 2016 The Authors. Published by Elsevier Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).

Funders: CSL Ltd
Date Deposited: 10 Oct 2016 03:55
FoR Codes: 11 MEDICAL AND HEALTH SCIENCES > 1103 Clinical Sciences > 110309 Infectious Diseases @ 34%
11 MEDICAL AND HEALTH SCIENCES > 1108 Medical Microbiology > 110804 Medical Virology @ 33%
11 MEDICAL AND HEALTH SCIENCES > 1117 Public Health and Health Services > 111716 Preventive Medicine @ 33%
SEO Codes: 92 HEALTH > 9201 Clinical Health (Organs, Diseases and Abnormal Conditions) > 920109 Infectious Diseases @ 50%
92 HEALTH > 9204 Public Health (excl. Specific Population Health) > 920412 Preventive Medicine @ 50%
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