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NCT01067781 · ClinicalTrials.gov registry record · Phase 2
Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch
A Phase 2 study, sponsored by Intercell USA.
- Completed
- Registry status
- Phase 2
- Development phase
- 600
- Enrollment target
NCT01067781: Completed Phase 2 study, sponsored by Intercell USA.
NCT01067781 is a Phase 2 study that has completed, run by Intercell USA. The registered enrollment target is 600 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (351% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01067781, a Phase 2 study, has completed, sponsored by Intercell USA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 600 participants
- Enrollment target
Study 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
Primary Outcome
Erythema, rash, pain, pruritus, hyperpigmentation, hypopigmentation and edema were solicited local AEs for the duration of the study. Fever, malaise, headache, and diarrhea were solicited systemic AEs for the first seven days following each vaccination; events reported outside this time frame were considered non-solicited.
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Heat-Labile Enterotoxin of E. coli (LT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2010-02 |
| Est. Completion | 2012-03 |
| Phase | Phase 2 |
What the finished NCT01067781 record still lists
NCT01067781 is an interventional study that assigns participants to a tested intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (351% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01067781 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01067781 about?
NCT01067781 is a clinical study titled "Safety and Immunogenicity Study of Traveler's Diarrhea Vaccine Patch". 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
What is the current status of trial NCT01067781?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 600 participants. The study started on 2010-02. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01067781?
The interventions under investigation include: Placebo (BIOLOGICAL), Heat-Labile Enterotoxin of E. coli (LT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01067781?
This trial is sponsored by Intercell USA, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01067781's enrollment target sits among peer trials
600 53rd of 2000 higher than 1,945 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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