Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine.
To augment the available influenza vaccine supply, a phase III study was conducted to evaluate the immunogenicity, safety, and consistency of a new trivalent inactivated influenza vaccine manufactured by CSL Limited. Healthy adults (ages 18-64) were randomized to receive either a single dose of TIV from multi-dose vials with thimerosal, TIV from pre-filled syringes without thimerosal, or placebo. Of the TIV recipients, 97.8% achieved a post-vaccination titer > or =40 against H1N1, 99.9% against H3N2 component, and 94.2% against influenza B. Few local or systemic adverse events were noted after vaccination with either TIV presentation. TIV was well tolerated and immunogenic.
Talbot
H Keipp
HK
Vanderbilt University School of Medicine and Pediatrics, Vanderbilt University Medical Center, 1161 21st Avenue South, Nashville, TN 37232, USA. keipp.talbot@vanderbilt.edu
Keitel
Wendy
W
Cate
Thomas R
TR
Treanor
John
J
Campbell
James
J
Brady
Rebecca C
RC
Graham
Irene
I
Dekker
Cornelia L
CL
Ho
Dora
D
Winokur
Patricia
P
Walter
Emmanuel
E
Bennet
Jillian
J
Formica
Neil
N
Hartel
Gunter
G
Skeljo
Maryanne
M
Edwards
Kathryn M
KM
D000328:Adult; D004311:Double-Blind Method; 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 / Q000008:administration & dosage / Q000276:immunology* / Q000592:standards*; D007251:Influenza, Human / Q000517:prevention & control*; D008297:Male; D008875:Middle Aged; D013849:Thimerosal; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
D007252:Influenza Vaccines; D015164:Vaccines, Inactivated; D013849:Thimerosal