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A Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Dose of OVX836 Influenza Vaccine at Two Dose Levels (90 µg and 180 μg), in Comparison to Influvac TetraTM, Quadrivalent Seasonal Influenza Sub-unit Vaccine, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years

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Trial Profile

A Phase 2a, Single Center, Randomized, Double-blind, Controlled Study to Evaluate the Immunogenicity and the Safety of One Dose of OVX836 Influenza Vaccine at Two Dose Levels (90 µg and 180 μg), in Comparison to Influvac TetraTM, Quadrivalent Seasonal Influenza Sub-unit Vaccine, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 08 Aug 2022

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At a glance

  • Drugs OVX-836 (Primary) ; Influenza vaccine quadrivalent Abbott Biologicals
  • Indications Influenza virus infections
  • Focus Pharmacodynamics
  • Acronyms OVX836-002
  • Sponsors OSIVAX

    • Most Recent Events

    • 21 Apr 2022 According to an OSIVAX media release, topline data from the study were announced previously in December of 2021 and also have been presented at the 2022 World Vaccine Congress.
    • 21 Apr 2022 Primary endpoint has been met. (NP-specific IFN T-cell increase measured by ELISPOT at Day 8 versus pre-injection baseline (Day 1) in the pooled age strata), according to an OSIVAX Media Release.
    • 21 Apr 2022 Results published in the OSIVAX Media Release.

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