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 L., 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: 4991-4997. doi:10.1016/j.vaccine.2016.08.038


Author 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 L.
Hartel, Gunter F.
Lai, Michael H.
Rockman, Steven
Greenberg, Michael E.
Title Efficacy of a trivalent influenza vaccine against seasonal strains and against 2009 pandemic H1N1: a randomized, placebo-controlled trial
Journal name Vaccine   Check publisher's open access policy
ISSN 1873-2518
0264-410X
Publication date 2016-09-22
Sub-type Article (original research)
DOI 10.1016/j.vaccine.2016.08.038
Open Access Status DOI
Volume 34
Issue 41
Start page 4991
End page 4997
Total pages 7
Place of publication London, United Kingdom
Publisher Elsevier
Language eng
Subject 1313 Molecular Medicine
2400 Immunology and Microbiology
3400 Veterinary
2739 Public Health, Environmental and Occupational Health
2725 Infectious Diseases
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. Funded by CSL Limited, ClinicalTrials.gov identifier NCT00562484
Formatted 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. Funded by CSL Limited, ClinicalTrials.gov identifier NCT00562484
Keyword Cross-protection
H1N1 subtype
Influenza A virus
Influenza vaccine efficacy
Seasonal influenza
Seasonal trivalent inactivated influenza vaccine
Q-Index Code C1
Q-Index Status Provisional Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
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