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Phase 2a, Single Center, Randomized, Double-blind, Study to Evaluate the Immunogenicity and Safety of One Single Administration of OVX836 Influenza Vaccine At Two Dose Levels (180µg or 480??g) Given Intramuscularly (IM), Either As a Booster or a Primary Vaccination in Healthy Adults Previously Administered with OVX836, Influvac Tetra® or Placebo in the OVX836-002 (EudraCT Number: 2019-002939-28) and OVX836-003 (EudraCT Number: 2021-002535-39) Studies.

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Trial Profile

Phase 2a, Single Center, Randomized, Double-blind, Study to Evaluate the Immunogenicity and Safety of One Single Administration of OVX836 Influenza Vaccine At Two Dose Levels (180µg or 480??g) Given Intramuscularly (IM), Either As a Booster or a Primary Vaccination in Healthy Adults Previously Administered with OVX836, Influvac Tetra® or Placebo in the OVX836-002 (EudraCT Number: 2019-002939-28) and OVX836-003 (EudraCT Number: 2021-002535-39) Studies.

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 09 Jan 2025

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At a glance

  • Drugs OVX-836 (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions
  • Sponsors OSIVAX

    • Most Recent Events

    • 31 Dec 2024 Primary endpoint focusing on pharmacodynamic and efficacy parameters cancelled and new primary endpoint focusing safety has been added newly.
    • 31 Dec 2024 Planned number of patients changed from 214 to 220.
    • 31 Dec 2024 Planned End Date changed from 1 Aug 2025 to 1 Jun 2025.

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