At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 120 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, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Immunogenicity and Safety of a Two Vaccination Regimen With an LT Vaccine Patch in Healthy Adults
In Brief
A Phase 2 clinical trial evaluating heat-labile enterotoxin of E. coli (LT) and Placebo for Prevention of Travelers' Diarrhea. Completed, enrolled 120 participants across 3 sites.
Detailed Summary
To evaluate and compare the immune responses and safety following a two vaccination regimen by transcutaneous immunization with heat-labile enterotoxin of E. coli (LT) patches or placebo patches.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevention of Travelers' Diarrhea
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2008
First PostedSep 2008
Primary CompletionNov 2009
TodayJul 2026
First PostedSep 12, 2008
Enrollment StartSep 1, 2008
Primary CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 17.8 years ago
Interventions
heat-labile enterotoxin of E. coli (LT)biological
Travelers' Diarrhea Vaccine System
Placebobiological
Travelers' Diarrhea Vaccine System