Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years.

Trial Profile

Lot Consistency, Immunogenicity, and Safety Study of Three Lots of Fluzone Vaccine Administered by Intradermal Route in Comparison With Standard Fluzone Administered Intramuscularly in Adult Subjects Aged 18 to 64 Years.

Completed
Phase of Trial: Phase III

Latest Information Update: 04 Apr 2014

At a glance

  • Drugs Influenza virus vaccine (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Sanofi
  • Most Recent Events

    • 11 Mar 2013 Primary endpoint 'Seroconversion-rate' has not been met.
    • 11 Mar 2013 Primary endpoint 'Geometric-mean-antibody-titre' has been met.
    • 26 Oct 2010 Data on study FID31 were presented at the 48th Annual Meeting of the Infectious Diseases Society of America (IDSA 2010), according to a sanofi-pasteur media release.
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