NCT02094586

A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults

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: Phase 3
• Study type: Interventional
• Enrollment: 3,146 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The primary goal of this Phase III study is to compare 3 lots for consistency of manufacture.

Detailed description

The primary goal of this Phase III study is to compare three lots for consistency of manufacture.

Conditions

• Cholera

Interventions

Type	Name	Description
BIOLOGICAL	PXVX0200 Lot A	Lot P700-1CA03
BIOLOGICAL	PXVX0200 Lot B	Lot P700-3CA03
BIOLOGICAL	PXVX0200 Lot C	Lot P700-6BA03
BIOLOGICAL	Placebo	Placebo

Timeline

• Start date: 2014-05-01
• Primary completion: 2015-02-01
• Completion: 2015-06-01
• First posted: 2014-03-24
• Last updated: 2023-06-28
• Results posted: 2021-07-15

Locations

25 sites across 2 countries: United States, Australia