At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 160 enrolled
Drug / intervention
heat-labile enterotoxin of E. coli (LT)biological
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, Open-Label Study to Compare the Immunogenicity and Safety of a Self-Administered LT Vaccine Patch With an LT Vaccine Patch Administered by a Clinician
In Brief
A Phase 2 clinical trial evaluating heat-labile enterotoxin of E. coli (LT) for Prevention of Travelers' Diarrhea. Completed, enrolled 160 participants across 3 sites.
Detailed Summary
To evaluate the immune responses achieved following self-administered heat-labile enterotoxin of E. coli (LT) vaccination by transcutaneous immunization compared to the immune responses achieved by clinician-administered vaccination.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevention of Travelers' Diarrhea
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedNov 2007
Primary CompletionJul 2008
Study CompletionAug 2008
TodayJul 2026
First PostedNov 30, 2007
Enrollment StartNov 1, 2007
Primary CompletionJul 1, 2008
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 18.6 years ago
Interventions
heat-labile enterotoxin of E. coli (LT)biological
37.5ug patch applied on either the deltoid or the thigh