Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study

Travelers' Diarrhea Clinical Trial

Official title:
A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of the Travelers' Diarrhea Vaccine System to actively immunize against Enterotoxigenic Escherichia coli disease in a field setting.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00993681
Study type	Interventional
Source	Intercell USA, Inc.
Contact
Status	Completed
Phase	Phase 3
Start date	October 2009
Completion date	April 2011

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT00564863` - Dose-Finding Study of CS19 Expressing ETEC Challenge Strains	Phase 1
Completed	`NCT00564577` - Dose-Finding Study of WS6788A and LSN03-016011/A Enterotoxigenic E. Coli ETEC Challenge Strains That Express CS17	Phase 1
Terminated	`NCT01005849` - Probiotics and the Prevention of Traveler's Diarrhea	Phase 4
Completed	`NCT02498301` - Trial Evaluating Chemoprophylaxis Against Travelers' Diarrhea - Prevent TD	N/A
Withdrawn	`NCT00875875` - Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea	Phase 4
Completed	`NCT00292344` - Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea	Phase 4
Completed	`NCT00524004` - Safety and Efficacy of Bovine Milk Immunoglobulin Against CS17 and CsbD	Phase 2
Terminated	`NCT02920242` - A Study Comparing Two Rifaximin Tablets in Patients With Travelers' Diarrhea.	Phase 3