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A Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE (MVA-BN) Smallpox Vaccine in Healthy, Vaccinia-Naive Subjects

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Trial Profile

A Randomized, Double-Blind, Placebo-Controlled Phase III Trial to Evaluate Immunogenicity and Safety of Three Consecutive Production Lots of IMVAMUNE (MVA-BN) Smallpox Vaccine in Healthy, Vaccinia-Naive Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Nov 2021

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At a glance

  • Drugs Modified vaccinia Ankara (Primary)
  • Indications Smallpox
  • Focus Registrational; Therapeutic Use
  • Sponsors Bavarian Nordic

    • Most Recent Events

    • 20 Feb 2020 According to a Bavarian Nordic media release, in Jan 2020, the company completed the sale of the Priority Review Voucher, granted by the FDA in connection with the approval of JYNNEOS in 2019.
    • 24 Sep 2019 According to a Bavarian Nordic media release, concurrent with the approval, FDA granted Bavarian Nordic a Priority Review Voucher (PRV) under the Material Threat Medical Countermeasure PRV program.
    • 24 Sep 2019 According to a Bavarian Nordic media release, based on the results of 22 clinical studies including POX-MVA013 and POX-MVA006, U.S. Food and Drug Administration (FDA) has approved JYNNEOS (Smallpox and Monkeypox Vaccine, Live, Non-replicating) (MVA-BN, liquid-frozen) for prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high risk for smallpox or monkeypox infection.

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