Trial Profile
Phase 3 Randomized, Double-blind, Placebo-Controlled 3-Lot Study in Healthy Volunteers to Assess Immunogenicity, & Acceptability of a Single-dose of Live Oral Cholera Vaccine, Vibrio Cholerae O1 Serotype Inaba Vaccine Strain CVD 103-HgR
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 03 Jul 2023
Price :
$35
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At a glance
- Drugs PXVX 0200 (Primary)
- Indications Cholera
- Focus Pharmacodynamics; Registrational
- Sponsors Bavarian Nordic; Emergent BioSolutions; PaxVax
- 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.