A Phase III Randomized, Double-blind, Placebo-controlled Study in Older Adults to Assess Immunogenicity and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

Trial Profile

A Phase III Randomized, Double-blind, Placebo-controlled Study in Older Adults to Assess Immunogenicity and Clinical Acceptability of a Single-dose of the Live Oral Cholera Vaccine Candidate PXVX0200 Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR

Completed
Phase of Trial: Phase III

Latest Information Update: 10 Jun 2016

At a glance

  • Drugs PXVX 0200 (Primary)
  • Indications Cholera
  • Focus Pharmacodynamics; Registrational
  • Sponsors PaxVax
  • Most Recent Events

    • 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.
    • 15 Jul 2015 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.
    • 02 Sep 2014 Status changed from recruiting to active, no longer recruiting as reported by ClinicalTrials.gov record.
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