At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 600 enrolled
Drug / intervention
Heat-Labile Enterotoxin of E. coli (LT) +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Gender-Stratified, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Two Vaccination Regimen With the Travelers' Diarrhea Vaccine System in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating Heat-Labile Enterotoxin of E. coli (LT) and Placebo for Diarrhea. Completed, enrolled 600 participants across 5 sites.
Detailed Summary
The purpose of this study is to evaluate and compare the safety and immune responses following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or Placebo, with or without alcohol swabbing
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiarrhea
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2010
First PostedFeb 2010
Primary CompletionSep 2010
Study CompletionMar 2012
TodayJul 2026
First PostedFeb 12, 2010
Enrollment StartFeb 1, 2010
Primary CompletionSep 1, 2010
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 16.4 years ago
Interventions
Heat-Labile Enterotoxin of E. coli (LT)biological
Travelers' Diarrhea Vaccine System
Placebobiological
Travelers' Diarrhea Vaccine System