Giuseppe
Emeritus
J Infect Dis. 2009 Aug 12. [Epub ahead of print]
Subunit Influenza Vaccines Produced from Cell Culture or in Embryonated Chicken Eggs: Comparison of Safety, Reactogenicity, and Immunogenicity.
Reisinger KS, Block SL, Izu A, Groth N, Holmes SJ. - Primary Physician's Research, Pittsburgh, Pennsylvania; 2Kentucky Pediatric/Adult Research, Bardstown, Kentucky; 3Global Clinical Research and Development, Novartis Vaccines and Diagnostics, Cambridge, Massachusetts; 4Global Clinical Research and Development, Novartis Vaccines and Diagnostics, Siena, Italy.
Background.
This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV).
Methods.
Adult subjects ([Formula: see text]; 18 to <50 years of age) were randomized (1:1) to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines were assessed on the basis of solicited indicators and other adverse events (AEs) within 7 days of vaccination. All serious AEs and those AEs resulting in withdrawal were recorded throughout the study. Antibody titers were determined by the hemagglutination inhibition assay, using egg- and cell-derived antigens. Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and seroconversion rates.
Results.
There was no clinically relevant difference between the safety and reactogenicity profiles of the 2 vaccines. The immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, seroprotection rates, and seroconversion rates were comparable between the 2 vaccines.
Conclusions.
The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.
PMID: 19673652 [PubMed - as supplied by publisher]
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Subunit Influenza Vaccines Produced from Cell Culture or in Embryonated Chicken Eggs: Comparison of Safety, Reactogenicity, and Immunogenicity.
Reisinger KS, Block SL, Izu A, Groth N, Holmes SJ. - Primary Physician's Research, Pittsburgh, Pennsylvania; 2Kentucky Pediatric/Adult Research, Bardstown, Kentucky; 3Global Clinical Research and Development, Novartis Vaccines and Diagnostics, Cambridge, Massachusetts; 4Global Clinical Research and Development, Novartis Vaccines and Diagnostics, Siena, Italy.
Background.
This study assessed the safety, reactogenicity, and immunogenicity of an injectable cell culture-derived influenza vaccine (CCIV), compared with those of an injectable egg-based trivalent inactivated influenza vaccine (TIV).
Methods.
Adult subjects ([Formula: see text]; 18 to <50 years of age) were randomized (1:1) to receive either CCIV or TIV. The safety and reactogenicity of the 2 vaccines were assessed on the basis of solicited indicators and other adverse events (AEs) within 7 days of vaccination. All serious AEs and those AEs resulting in withdrawal were recorded throughout the study. Antibody titers were determined by the hemagglutination inhibition assay, using egg- and cell-derived antigens. Immunogenicity was assessed on the basis of the ratio of postvaccination (day 22) geometric mean titers (GMTs) between the 2 vaccines, seroprotection rates, and seroconversion rates.
Results.
There was no clinically relevant difference between the safety and reactogenicity profiles of the 2 vaccines. The immunogenicity of CCIV was demonstrated to be noninferior to that of TIV on the basis of the ratio of postvaccination GMTs between the 2 vaccines. GMTs, seroprotection rates, and seroconversion rates were comparable between the 2 vaccines.
Conclusions.
The safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable.
PMID: 19673652 [PubMed - as supplied by publisher]
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