Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine

H Keipp Talbot, 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, H Keipp Talbot, 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

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.

Figures

Figure 1
Figure 1
Flow Chart of Subject Disposition

Source: PubMed

3
Subscribe