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A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination

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Trial Profile

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 30 Jun 2023

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At a glance

  • Drugs PXVX 0200 (Primary)
  • Indications Cholera
  • Focus Registrational; Therapeutic Use
  • Sponsors Bavarian Nordic; Emergent BioSolutions; PaxVax

    • Most Recent Events

    • 13 Feb 2019 Results assessing age related immunogenicity and reactogenicity of live oral cholera vaccine CVD 103-HgR in the Older Adult Study, the Lot Consistency Study and the Challenge Study, published in the Vaccine
    • 11 Apr 2018 Results assessing the association between memory B cell responses and protection against challenge administered published in the Vaccine
    • 10 Jun 2016 According to a PaxVax media release, the company has received marketing approval from the United States (U.S.) Food and Drug Administration (FDA) for Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. Data from this and other two safety and immunogenicity trials (Profile 242534 and 242926) supported the approval.
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