Clinical Trial: Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System
Brief 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.
Detailed Summary:
Sponsor: Intercell USA, Inc.
Current Primary Outcome: Incidence of cases with vaccine preventable outcome [ Time Frame: Day 17 (17 days after arrival in destination country) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- The incidence of moderate/severe diarrhea [ Time Frame: Day 17 (17 days after arrival in destination country) ]
- Total unformed stool frequency from diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ]
- Total duration of diarrheal episodes [ Time Frame: Day 17 (17 days after arrival in destination country) ]
Original Secondary Outcome: Same as current
Information By: Intercell USA, Inc.
Dates:
Date Received: October 8, 2009
Date Started: October 2009
Date Completion:
Last Updated: March 13, 2012
Last Verified: March 2012
