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A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults Greater Than or Equal to 18 to Less Than 65 Years of Age

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Trial Profile

A Phase III, Randomized, Double-Blinded, Placebo-Controlled, Multi-Center Study to Evaluate the Immunogenicity, Safety and Tolerability of CSL Limited Inactivated Influenza Vaccine in Adults Greater Than or Equal to 18 to Less Than 65 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Sep 2008

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At a glance

  • Drugs Influenza virus vaccine (Afluria) (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics

    • Most Recent Events

    • 03 Sep 2008 Results formed the basis of the licensing application, which was approved by the US FDA in September 2007, according to a CSL media release.
    • 29 Jul 2008 Secondary endpoint 'Haemagglutin inhibition antibody levels' has been met.
    • 29 Jul 2008 Primary endpoint 'Seroprotection rate' has been met.

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