Giuseppe
Emeritus
J Infect Dis. 2009 Dec 15;200(12):1861-1869.
Efficacy of Inactivated Split-Virus Influenza Vaccine against Culture-Confirmed Influenza in Healthy Adults: A Prospective, Randomized, Placebo-Controlled Trial.
Beran J, Vesikari T, Wertzova V, Karvonen A, Honegr K, Lindblad N, Van Belle P, Peeters M, Innis BL, Devaster JM. - The Vaccination and Travel Medicine Center and 2Department of Infectious Diseases, University Hospital, Hradec Kralove, Czech Republic; 3Vaccine Research Center, University of Tampere, Finland; GlaxoSmithKline Biologicals, 4Rixensart, Belgium, and 5King of Prussia, Pennsylvania.
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 ([Formula: see text]) or placebo ([Formula: see text]). Influenza-like illnesses (ILI) (defined as at least 1 systemic symptom [fever {oral temperature, 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%; [Formula: see text]) and to any strain was 61.6% (95% CI, 46.0%-72.8%; [Formula: see text]).
Conclusion.
TIV is efficacious against culture-confirmed influenza in healthy adults.
Trial Registration. ClinicalTrials.gov identifier: NCT00363870 .
PMID: 19909082 [PubMed - as supplied by publisher]
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Efficacy of Inactivated Split-Virus Influenza Vaccine against Culture-Confirmed Influenza in Healthy Adults: A Prospective, Randomized, Placebo-Controlled Trial.
Beran J, Vesikari T, Wertzova V, Karvonen A, Honegr K, Lindblad N, Van Belle P, Peeters M, Innis BL, Devaster JM. - The Vaccination and Travel Medicine Center and 2Department of Infectious Diseases, University Hospital, Hradec Kralove, Czech Republic; 3Vaccine Research Center, University of Tampere, Finland; GlaxoSmithKline Biologicals, 4Rixensart, Belgium, and 5King of Prussia, Pennsylvania.
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 ([Formula: see text]) or placebo ([Formula: see text]). Influenza-like illnesses (ILI) (defined as at least 1 systemic symptom [fever {oral temperature, 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%; [Formula: see text]) and to any strain was 61.6% (95% CI, 46.0%-72.8%; [Formula: see text]).
Conclusion.
TIV is efficacious against culture-confirmed influenza in healthy adults.
Trial Registration. ClinicalTrials.gov identifier: NCT00363870 .
PMID: 19909082 [PubMed - as supplied by publisher]
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