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A Phase 3, Randomized, Observer-blinded, Active-controlled Trial to Evaluate Immunogenicity & Safety of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With Matrix-M1 Adjuvant Against Fluzone Quadrivalent in Clinically Stable Adults ≥ 65 Years of Age

Trial Profile

A Phase 3, Randomized, Observer-blinded, Active-controlled Trial to Evaluate Immunogenicity & Safety of a Recombinant Quadrivalent Nanoparticle Influenza Vaccine (Quad-NIV) With Matrix-M1 Adjuvant Against Fluzone Quadrivalent in Clinically Stable Adults ≥ 65 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 May 2023

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At a glance

  • Drugs Seasonal-influenza-nanoparticle-vaccine-Novavax (Primary) ; Influenza virus vaccine
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Novavax
  • Most Recent Events

    • 11 Apr 2023 The protocol has been amended as above- 1) New primary endpoint has been added -Mean Difference in the Seroconversion Rate (SCR) HAI Antibody Responses. Time frames of adverse events has been differentiated.2)status has been completed.
    • 11 Apr 2023 Status changed from active, no longer recruiting to completed.
    • 20 Apr 2022 According to a Novavax media release, data were presented at the World Vaccine Congress (WVC).
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