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Keith S. Reisinger, Stanley L. Block, Allen Izu, Nicola Groth, Sandra J. Holmes, Subunit Influenza Vaccines Produced from Cell Culture or in Embryonated Chicken Eggs: Comparison of Safety, Reactogenicity, and Immunogenicity, The Journal of Infectious Diseases, Volume 200, Issue 6, September 2009, Pages 849–857, https://doi.org/10.1086/605506
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Abstract
BackgroundThis 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)
MethodsAdult subjects (n=613; 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
ResultsThere 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
ConclusionsThe safety, reactogenicity, and immunogenicity of the CCIV and the egg-based TIV are comparable