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A Phase 3 Lot to Lot Consistency Study of Live Oral Cholera Vaccine, PXVX0200 in Healthy Adults | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

NCT02094586•Bavarian Nordic

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•healthy men or women,
•age 18 to 45 years inclusive;
•normal medical history and physical examination
•Women must have a negative pregnancy test.

Exclusion Criteria

•travel to a cholera endemic area in the previous 5 years;
•abnormal stool pattern or regular use of laxatives;
•Currently active unstable or undiagnosed medical conditions
•current or recent antibiotic use;
•pregnancy or nursing;
•Previously received a licensed or investigational cholera vaccine
•History of cholera or enterotoxigenic E. coli infection
•History of Guillain-Barré Syndrome
•Received or plans to receive any other licensed vaccines, except for seasonal influenza
•Recipient of bone marrow or solid organ transplant
+3 more criteria

Locations (25)

Coastal Clinical Research

Mobile, Alabama, United States

Clinical Reseach Consortium Arizona

Phoenix, Arizona, United States

Avail Clinical Research

DeLand, Florida, United States

Miami Research Associates

Miami, Florida, United States

Palm Beach Research

West Palm Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

Johnson County Clin-Trials

Lenexa, Kansas, United States

Heartland Research Associates

Wichita, Kansas, United States

Central Kentucky Research

Lexington, Kentucky, United States

University of Kentucky

Lexington, Kentucky, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

February 1, 2015

Completion Date

June 1, 2015

Last Updated

June 28, 2023

Enrollment

3,146

ACTUAL participants

Conditions

Cholera

Interventions

PXVX0200 Lot A

BIOLOGICAL

PXVX0200 Lot B

BIOLOGICAL

PXVX0200 Lot C

BIOLOGICAL

Placebo

BIOLOGICAL

Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance

NCT04853186

Cholera

View study

COMPLETEDPHASE2/PHASE3

Next Generation ORS: Controlled Trial Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea

NCT05814042

DiarrheaCholera

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UNKNOWNPHASE3

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Impact Study of Cholera Vaccination in Endemic Areas - Clinical Surveillance

Next Generation ORS: Controlled Trial Comparing ORS With Calcium vs Standard ORS in Reducing Severity of Acute Watery Diarrhea

Co-administration Study of OCV, TCV and MR

Cholera Anti-Secretory Treatment Trial

Immunogenicity of Cholera Vaccine in Children With IBD

Cholera Vaccine Investment Strategy in Bangladesh