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.
RCT Entities:
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.
Authors: James D Campbell; Christopher V Chambers; Rebecca C Brady; Michael C Caldwell; Nathan L Bennett; Marc A Fourneau; Varsha K Jain; Bruce L Innis Journal: Hum Vaccin Date: 2011-01-01
Authors: Roy E Strowd; Katrina Swett; Michele Harmon; Annette F Carter; Aurora Pop-Vicas; Michael Chan; Stephen B Tatter; Thomas Ellis; Maria Blevins; Kevin High; Glenn J Lesser Journal: Neuro Oncol Date: 2014-04-08 Impact factor: 12.300
Authors: Stefan P Kuster; Prakesh S Shah; Brenda L Coleman; Po-Po Lam; Agnes Tong; Anne Wormsbecker; Allison McGeer Journal: PLoS One Date: 2011-10-18 Impact factor: 3.240