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A Randomized, Double-Blinded Phase 3 Study to Demonstrate Lot-to-Lot Consistency of Three Lots of a Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Adults Aged 18 to 45 Years

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Trial Profile

A Randomized, Double-Blinded Phase 3 Study to Demonstrate Lot-to-Lot Consistency of Three Lots of a Live-Attenuated Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Adults Aged 18 to 45 Years

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Nov 2023

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At a glance

  • Drugs VLA 1553 (Primary)
  • Indications Chikungunya virus infections
  • Focus Pharmacodynamics; Registrational
  • Sponsors Valneva

Most Recent Events

  • 09 Nov 2023 According to a Valneva media release, the U.S. Food and Drug Administration approved Ixchiq, chikungunya vaccine for individuals 18 years of age and older who are at increased risk of exposure to chikungunya virus.
  • 29 Aug 2023 According to a Valneva media release, the company intends to make additional regulatory submissions in 2023. A Biologic License Application (BLA) is currently under priority review1 by the U.S. Food and Drug Administration (FDA).
  • 29 Aug 2023 According to a Valneva media release, Health Canada accepts chikungunya vaccine license application for review. The New Drug Submission (NDS) application is sufficiently complete to permit a substantive review. Based on Health Canadas performance standard to process an NDS application, the Company believes the regulatory review could be completed by mid-2024.

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