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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 O1 Serotype Inaba Strain CVD 103-HgR

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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 O1 Serotype Inaba Strain CVD 103-HgR

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2023

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At a glance

  • Drugs PXVX 0200 (Primary)
  • Indications Cholera
  • Focus Pharmacodynamics; Registrational
  • 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
    • 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.

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