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A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age

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Trial Profile

A Phase 3 Safety and Immunogenicity Trial of the VLP-Based Chikungunya Virus Vaccine PXVX0317 in Adults ≥65 Years of Age

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Mar 2024

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At a glance

  • Drugs VRC-CHKVLP059-00-VP (Primary) ; Aluminium hydroxide
  • Indications Chikungunya virus infections
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Sponsors Bavarian Nordic

    • Most Recent Events

    • 06 Mar 2024 According to a Bavarian Nordic media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated assessment for the upcoming Marketing Authorisation Application (MAA) for CHIKV VLP.
    • 23 Feb 2024 According to a Bavarian Nordic media release, company is on track and plans to submit its MAA for CHIKV VLP to the EMA during H1 2024. Company also plans to submit our biologics license application (BLA) for vaccine candidate to the U.S. Food and Drug Administration later this year.
    • 08 Sep 2023 Status changed from active, no longer recruiting to completed.
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