Efficacy of inactivated split-virus influenza vaccine against culture-confirmed influenza in healthy adults: a prospective, randomized, placebo-controlled trial
Language English Country United States Media print
Document type Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
19909082
DOI
10.1086/648406
Knihovny.cz E-resources
- MeSH
- Influenza, Human prevention & control virology MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Vaccines, Inactivated immunology MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Placebos administration & dosage MeSH
- Prospective Studies MeSH
- Vaccines, Subunit immunology MeSH
- Influenza Vaccines immunology MeSH
- Influenza A Virus, H1N1 Subtype immunology isolation & purification MeSH
- Influenza A Virus, H3N2 Subtype immunology isolation & purification MeSH
- Influenza B virus immunology isolation & purification MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Geographicals
- Czech Republic MeSH
- Finland MeSH
- Names of Substances
- Vaccines, Inactivated MeSH
- Placebos MeSH
- Vaccines, Subunit MeSH
- Influenza Vaccines MeSH
BACKGROUND: A new trivalent inactivated split-virus influenza vaccine (TIV) was recently introduced in the United States. We assessed the efficacy of TIV against culture-confirmed influenza A and/or B. METHODS: In this double-blind trial conducted from September 2006 to May 2007 in the Czech Republic and Finland, participants aged 18-64 years were randomized to receive 1 dose of TIV (n = 5103) or placebo (n = 2549). Influenza-like illnesses (ILI) (defined as at least 1 systemic symptom [fever {oral temperature, > or = 37.8 degrees C} and/or myalgia] and at least 1 respiratory symptom [cough and/or sore throat]) were identified by both active (biweekly phone contact) and passive surveillance. Nasal and throat swab specimens were collected for viral culture. RESULTS: The attack rate for culture-confirmed ILI was 3.2% in the placebo group, with most strains identified as influenza A (all except 1 were H3N2) matching the vaccine strain. There were 6 cases of influenza B, all of which were of a different lineage (Yamagata) than the vaccine strain. Vaccine efficacy against culture-confirmed influenza A and/or B due to strains antigenically matched to the vaccine was 66.9% (95% confidence interval [CI], 51.9%-77.4%; P < .001) and to any strain was 61.6% (95% CI, 46.0%-72.8%; P < .001). CONCLUSION: TIV is efficacious against culture-confirmed influenza in healthy adults. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00363870.
References provided by Crossref.org
ClinicalTrials.gov
NCT00363870
