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

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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