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A Randomized, Double-blind, Multicenter Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of a Freeze-dried Formulation of MVA-BN Smallpox Vaccine in Healthy, Vaccinia-naive Subjects

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Trial Profile

A Randomized, Double-blind, Multicenter Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of a Freeze-dried Formulation of MVA-BN Smallpox Vaccine in Healthy, Vaccinia-naive Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jun 2024

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At a glance

  • Drugs Modified vaccinia Ankara (Primary)
  • Indications Smallpox
  • Focus Pharmacodynamics; Registrational
  • Sponsors Bavarian Nordic
  • Most Recent Events

    • 31 May 2024 According to a Bavarian Nordic media release, Following a standard review time of 10 months for the sBLA, approval of the freeze-dried formulation could be obtained in the first quarter of 2025.
    • 31 May 2024 According to a Bavarian Nordic media release, based on clinical data from a Phase 3 lot consistency study and data from a Phase 2 study, today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of a freeze-dried formulation of JYNNEOS for prevention of smallpox and mpox disease in adults 18 years of age and older.
    • 29 Nov 2022 Results assessing the immunogenicity and safety of 3 consecutively produced lots of freeze-dried MVA-BN vaccine in healthy adults, published in the Vaccine.

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