Immunogenicity, safety and consistency of new trivalent inactivated influenza vaccine

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

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.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Double-Blind Method
  • Female
  • Humans
  • Influenza A Virus, H1N1 Subtype / immunology
  • Influenza A Virus, H3N2 Subtype / immunology
  • Influenza B virus / immunology
  • Influenza Vaccines / administration & dosage
  • Influenza Vaccines / immunology*
  • Influenza Vaccines / standards*
  • Influenza, Human / prevention & control*
  • Male
  • Middle Aged
  • Thimerosal
  • Vaccines, Inactivated / administration & dosage
  • Vaccines, Inactivated / adverse effects
  • Vaccines, Inactivated / immunology
  • Young Adult

Substances

  • Influenza Vaccines
  • Vaccines, Inactivated
  • Thimerosal