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A Randomized, Open-label Phase III Non-inferiority Trial to Compare Indicators of Efficacy for MVA-BN Smallpox Vaccine to ACAM2000 in 18-40 Year Old Healthy Vaccinia-naive Subjects

Trial Profile

A Randomized, Open-label Phase III Non-inferiority Trial to Compare Indicators of Efficacy for MVA-BN Smallpox Vaccine to ACAM2000 in 18-40 Year Old Healthy Vaccinia-naive Subjects

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Sep 2019

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At a glance

  • Drugs Smallpox vaccine (Primary) ; ACAM 2000
  • Indications Smallpox
  • Focus Pharmacodynamics; Registrational
  • Sponsors Bavarian Nordic
  • Most Recent Events

    • 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.
    • 11 Mar 2019 According to a Bavarian Nordic media release, the U.S. FDA review of the BLA for the liquid-frozen formulation of the MVA-BN for active immunization against smallpox will be extended by three months. The FDA now requires more time and has extended the target PDUFA action date to September 2019. This submission is based on the comprehensive development program, comprising 22 clinical studies, including POX-MVA006 and POX-MVA013 studies.
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