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A Phase 3, Randomized, Double-blind, Parallel-group Trial to Evaluate the Lot Consistency, Immunogenicity, and Safety of AV7909 for Postexposure Prophylaxis of Anthrax in Healthy Adults

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Trial Profile

A Phase 3, Randomized, Double-blind, Parallel-group Trial to Evaluate the Lot Consistency, Immunogenicity, and Safety of AV7909 for Postexposure Prophylaxis of Anthrax in Healthy Adults

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2024

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At a glance

  • Drugs Anthrax vaccine adsorbed adjuvanted Emergent BioSolutions (Primary) ; Anthrax vaccine
  • Indications Anthrax
  • Focus Adverse reactions; Pharmacodynamics; Registrational
  • Acronyms VELOCITY
  • Sponsors Emergent BioSolutions

    • Most Recent Events

    • 20 Jul 2023 According to an Emergent BioSolutions media release, the company has received U.S. FDA Approval of CYFENDUS vaccine based on data from this study.
    • 24 Jun 2022 According to an Emergent BioSolutions media release, the company announced that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for AV7909, the rolling BLA submission, completed in April 2022, is based on data from this study. The Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2023.
    • 09 Nov 2020 Status changed from active, no longer recruiting to completed.
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