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NCT01382095 · ClinicalTrials.gov registry record · Phase 1
Safety Study of Recombinant Vaccine to Prevent ETEC Diarrhea
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT01382095: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
NCT01382095 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01382095, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if immunization with a recombinant E. coli protein, dscCfaE, is safe and immunogenic when administered through the skin using a patch.
Primary Outcome
Adverse event monitoring will survey and specifically inquire about fever (oral temperature \> 100.4 o F), malaise, headache, rash, pain, diarrhea, abdominal pain, extremity pain or swelling. Clinical definitions will be used to grade severity of symptoms in accordance to the severity scale below: Grade 0 = None Grade 1= Barely noticeable Grade 2= Noticeable, does not interfere with daily activities Grade 3=Interferes with daily activities Grade 4=Prevents daily activities
Interventions
- BIOLOGICAL Recombinant fimbrial adhesin dscCfaE
- BIOLOGICAL Modified E. coli heat labile enterotoxin LTR192G
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01382095 record still lists
NCT01382095 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Recombinant fimbrial adhesin dscCfaE is the first listed.
NCT01382095 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01382095 about?
NCT01382095 is a clinical study titled "Safety Study of Recombinant Vaccine to Prevent ETEC Diarrhea". The purpose of the study is to determine if immunization with a recombinant E. coli protein, dscCfaE, is safe and immunogenic when administered through the skin using a patch.
What is the current status of trial NCT01382095?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2011-07. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01382095?
The interventions under investigation include: Recombinant fimbrial adhesin dscCfaE (BIOLOGICAL), Modified E. coli heat labile enterotoxin LTR192G (BIOLOGICAL).
Who is sponsoring clinical trial NCT01382095?
This trial is sponsored by U.S. Army Medical Research and Development Command, which has 77 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01382095's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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