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A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Quadrivalent Influenza Vaccine

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Trial Profile

A Phase II, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial to Assess the Safety, Reactogenicity and Immunogenicity of Two Doses of Multimeric-001 (M-001) Followed by Seasonal Quadrivalent Influenza Vaccine

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 04 Dec 2023

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At a glance

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

    • Most Recent Events

    • 18 Mar 2023 Results assessing the safety and immunogenicity of one such candidate, Multimeric-001 (M-001), when used as a priming vaccine prior to administration of quadrivalent inactivated influenza vaccine (IIV4), published in the Vaccine.
    • 10 Jun 2020 Results published in the BiondVax Pharmaceuticals Media Release.
    • 10 Jun 2020 According to an BiondVax Pharmaceuticals media release, this NIAID-supported Phase 2 trial was conducted under an FDA Investigational New Drug application (IND), and NIAID's Division of Microbiology and Infectious Diseases (DMID) has submitted the final CSR to the FDA. NIAID has communicated to BiondVax that the study's lead investigator may prepare a manuscript for publication sometime in the future.

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