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A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years)

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Trial Profile

A Pivotal Multi-center, Randomized, Modified Double-blind, Placebo-controlled Phase 3 Trial to Assess the Safety and Clinical Efficacy of M-001 Influenza Vaccine Administered Intra-muscularly Twice in Older Adults and Elderly (≥50 Years)

Status: Completed
Phase of Trial: Phase III

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; Registrational; Therapeutic Use
  • Sponsors BiondVax Pharmaceuticals; Scinai Immunotherapeutics

    • Most Recent Events

    • 29 Oct 2020 According to European Clinical Trials Database Record the trial is completed in Poland.
    • 23 Oct 2020 Results presented in a BiondVax Pharmaceuticals Media Release.
    • 23 Oct 2020 According to a BiondVax Pharmaceuticals media release, Primary endpoint (Clinical Efficacy: PCR and Culture Confirmed Influenza) has not been met.
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