A Phase III Randomized, Double-blind, Placebo-Controlled Three-Lot Consistency Study in Healthy Adult Volunteers 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
Phase of Trial: Phase III
Latest Information Update: 06 Jan 2018
At a glance
- Drugs PXVX 0200 (Primary)
- Indications Cholera
- Focus Pharmacodynamics; Registrational
- Sponsors PaxVax
- 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.
- 15 Jul 2015 Status changed from active, no longer recruiting to completed as per ClinicalTrials.gov record.