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Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years

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Trial Profile

Phase 2a, Randomized, Double-blind (Double-dummy), Double Placebo-controlled, Parallel-group Study to Evaluate the Immunogenicity and the Safety of the Concomitant Administration of OVX836 Influenza Vaccine and Quadrivalent Inactivated Influenza Vaccines (QIVs: Fluarix Tetra and Afluria Quad) Given Intramuscularly as 2 Separate Injections Into Opposite Arms, in Comparison to the Concomitant Administration of Quadrivalent Inactivated Influenza Vaccines and Placebo, and OVX836 and Placebo Given the Same Way in Healthy Subjects Aged 18 to 60 Years

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 28 Mar 2024

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At a glance

  • Drugs GSK 2321138A (Primary) ; Influenza vaccine (Optaflu) (Primary) ; OVX-836 (Primary)
  • Indications Influenza virus infections
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors OSIVAX

    • Most Recent Events

    • 26 Mar 2024 According to an Osivax media release, company announced that all participants have completed their final visit in this study. Topline results from this study are expected in the second half of 2024.
    • 24 Jan 2024 Status changed from active, no longer recruiting to completed.
    • 06 Sep 2023 Planned End Date changed from 3 Jan 2024 to 10 Jan 2024.

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