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J Infect Dis. 2009 Dec 15;200(12):1861-9. doi: 10.1086/648406.

Efficacy of inactivated split-virus influenza vaccine against culture-confirmed influenza in healthy adults: a prospective, randomized, placebo-controlled trial.

Author information

  • 1The Vaccination and Travel Medicine Center, University Hospital, 500 03 Hradec Kralove, Czech Republic. jiri.beran@vakcinace.cz

Abstract

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.

PMID:
19909082
[PubMed - indexed for MEDLINE]
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