NCT01895855

Safety and Efficacy Challenge Study of Live Oral Cholera Vaccine Candidate,PXVX0200, to Prevent Cholera

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose Live Oral Cholera Vaccine, PXVX0200 CVD 103-HgR, in Preventing Cholera Following Challenge With Vibrio Cholerae 10 Days or 3 Months After Vaccination

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine if PXVX0200 is safe and effective in preventing cholera infection

Detailed description

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Efficacy Trial of a Single Dose of Live Oral Cholera Vaccine Candidate, PXVX0200 CVD 103-HgR Strain, in Preventing Cholera following Challenge with Vibrio cholerae O1 El Tor Inaba 10 Days or 3 Months after Vaccination in volunteers aged 18-45 years

Conditions

• Cholera

Interventions

Type	Name	Description
BIOLOGICAL	PXVX0200	Single dose; liquid suspension after reconstitution with buffer; 5x10\^8
BIOLOGICAL	placebo

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2013-07-11
• Last updated: 2023-06-28
• Results posted: 2021-04-01

Locations

3 sites across 1 country: United States