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Clinical Trial
. 2008 Jul 29;26(32):4057-61.
doi: 10.1016/j.vaccine.2008.05.024. Epub 2008 Jun 2.

Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine

H Keipp Talbot  1 , Wendy Keitel, Thomas R Cate, John Treanor, James Campbell, Rebecca C Brady, Irene Graham, Cornelia L Dekker, Dora Ho, Patricia Winokur, Emmanuel Walter, Jillian Bennet, Neil Formica, Gunter Hartel, Maryanne Skeljo, Kathryn M Edwards
Affiliations
Clinical Trial

Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine

H Keipp Talbot et al. Vaccine. .

Abstract

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.

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Figures

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Figure 1
Flow Chart of Subject Disposition
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