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Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Participants Aged 65 Years and Older

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Trial Profile

Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine Administered by Intramuscular Route in Participants Aged 65 Years and Older

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Dec 2019

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At a glance

  • Drugs Influenza virus vaccine (Primary)
  • Indications Influenza virus infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors Sanofi Pasteur

    • Most Recent Events

    • 04 Nov 2019 According to an Sanofi media release, the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for Fluzone High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. This FDA approval was based on data from this Phase 3 immunogenicity and safety study
    • 17 Aug 2019 Results assessing safety and immunogenicity of a quadrivalent formulation of the high-dose split-virion inactivated influenza vaccine in adults published in the Vaccine
    • 23 Apr 2018 Status changed from active, no longer recruiting to completed.
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