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Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Single Administration of OVX836 Influenza Vaccine at Two Dose Levels (300μg and 480μg) Given Intramuscularly (IM), in Comparison to OVX836 Influenza Vaccine at 180μg and Placebo Given IM in Healthy Subjects Aged 18-55 Years and in Healthy Subjects Aged 65 Years and Older

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Trial Profile

Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Single Administration of OVX836 Influenza Vaccine at Two Dose Levels (300μg and 480μg) Given Intramuscularly (IM), in Comparison to OVX836 Influenza Vaccine at 180μg and Placebo Given IM in Healthy Subjects Aged 18-55 Years and in Healthy Subjects Aged 65 Years and Older

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 23 May 2024

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At a glance

  • Drugs OVX-836 (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics
  • Acronyms OVX836-003
  • Sponsors OSIVAX

    • Most Recent Events

    • 01 Dec 2023 Results (n=137; between Nov 15, 2021, and Feb 1, 2022) assessing the immunogenicity, safety, and preliminary efficacy of OVX836, published in The Lancet Infectious Diseases.
    • 27 Jul 2023 According to an OSIVAX media release, a separate cohort of 100 older adults (65 years old and older) was vaccinated (same doses and randomisation ratio as younger subjects) and will be reported separately, with full results expected by Q4 2023.
    • 27 Jul 2023 Results presented in the OSIVAX Media Release.

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