Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine.
(Clinical Trial, Phase III;Journal Article;Multicenter Study)
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, HK; Keitel, W; Cate, TR; Treanor, J; Campbell, J; Brady, RC; Graham, I; Dekker, CL; Ho, D; Winokur, P; Walter, E; Bennet, J; Formica, N; Hartel, G; Skeljo, M; Edwards, KM
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