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Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Consistency Study in Healthy Adult Volunteers to Assess Immunogenicity, and Clinical Acceptability of a Single-dose of Live Oral Cholera Vaccine Candidate PXVX0200, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

Trial Profile

Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Consistency Study in Healthy Adult Volunteers to Assess Immunogenicity, and Clinical Acceptability of a Single-dose of Live Oral Cholera Vaccine Candidate PXVX0200, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 13 Feb 2019

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At a glance

  • Drugs PXVX 0200 (Primary)
  • Indications Cholera
  • Focus Pharmacodynamics; Registrational
  • Sponsors 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
    • 06 Jan 2018 Results assessing immunogenicity and safety of a single-dose of the live oral cholera vaccine candidate PXVX 0200 in healthy adult subjects, were published in the Vaccine.
    • 10 Jun 2016 According to PaxVax media release, the company has announced that it 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 and also vaxchora is expected to be commercially available in Q3 2016.
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