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

Autor: Jim Reid, Gunter Hartel, William J. H. McBride, Leon Heron, William D. Rawlinson, Ian G. Barr, Simon Carson, Walter P. Abhayaratna, Jonathan R. Carapetis, Ferdinandus de Looze, Michael H. Lai, Sepehr Shakib, Helen Marshall, Rod Ellis-Pegler, Russell L. Basser, Jodie McVernon, Steven Rockman, Terry Nolan, Robert Booy, Michael Greenberg, Jeff Karrasch, Peter Richmond
Rok vydání: 2016
Předmět:
Adult
Male
0301 basic medicine
Trivalent influenza vaccine
medicine.medical_specialty
Placebo-controlled study
medicine.disease_cause
Placebo
Young Adult
03 medical and health sciences
Influenza A Virus
H1N1 Subtype
0302 clinical medicine
Immunology and Microbiology(all)
Internal medicine
Influenza
Human
Pandemic
medicine
Influenza A virus
Humans
030212 general & internal medicine
Influenza vaccine efficacy
Adverse effect
Seasonal influenza
General Veterinary
General Immunology and Microbiology
business.industry
Seasonal trivalent inactivated influenza vaccine
Australia
Public Health
Environmental and Occupational Health
virus diseases
Middle Aged
Vaccine efficacy
veterinary(all)
3. Good health
Vaccination
H1N1 subtype
030104 developmental biology
Infectious Diseases
Influenza Vaccines
Immunology
Molecular Medicine
Female
business
Cross-protection
New Zealand
Zdroj: Vaccine. 34:4991-4997
ISSN: 0264-410X
DOI: 10.1016/j.vaccine.2016.08.038
Popis: 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
Databáze: OpenAIRE
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