Efficacy of Inactivated Split-Virus Influenza Vaccine against Culture-Confirmed Influenza in Healthy Adults: A Prospective, Randomized, Placebo-Controlled Trial

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, ≥37.8°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 [Cl], 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.