Subunit influenza vaccines produced from cell culture or in embryonated chicken eggs: comparison of safety, reactogenicity, and immunogenicity.
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 (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.


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.
Reisinger
Keith S
KS
Primary Physician's Research, Pittsburgh, PA, USA.
Block
Stanley L
SL
Izu
Allen
A
Groth
Nicola
N
Holmes
Sandra J
SJ
D000293:Adolescent; D000328:Adult; D000818:Animals; D000914:Antibodies, Viral / Q000096:biosynthesis / Q000097:blood; D002642:Chick Embryo; D004285:Dogs; D005260:Female; D006801:Humans; D053118:Influenza A Virus, H1N1 Subtype / Q000276:immunology*; D053122:Influenza A Virus, H3N2 Subtype / Q000276:immunology*; D009981:Influenza B virus / Q000276:immunology*; D007252:Influenza Vaccines / Q000009:adverse effects* / Q000276:immunology*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D022223:Vaccines, Subunit / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D000914:Antibodies, Viral; D007252:Influenza Vaccines; D022223:Vaccines, Subunit