Trials / Completed
CompletedNCT00993681
Travelers' Diarrhea (TD) Vaccine Pivotal Efficacy Study
A Phase Three, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of the Travelers' Diarrhea Vaccine System
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,036 (actual)
- Sponsor
- Intercell USA, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TD Vaccine System | heat labile enterotoxin of E. coli (LT) |
| BIOLOGICAL | TD Vaccine System | placebo |
Timeline
- Start date
- 2009-10-01
- Primary completion
- 2010-11-01
- Completion
- 2011-04-01
- First posted
- 2009-10-12
- Last updated
- 2012-03-14
Locations
20 sites across 4 countries: Germany, Guatemala, Mexico, United Kingdom
Source: ClinicalTrials.gov record NCT00993681. Inclusion in this directory is not an endorsement.