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NCT00565461 · ClinicalTrials.gov registry record · Phase 2
LT Vaccine Patch Self-Administration Study
A Phase 2 study, sponsored by Intercell USA.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT00565461: Completed Phase 2 study, sponsored by Intercell USA.
NCT00565461 is a Phase 2 study that has completed, run by Intercell USA. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00565461, a Phase 2 study, has completed, sponsored by Intercell USA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study 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.
Primary Outcome
The primary endpoint of this trial was to compare the immunogenicity (i.e., GMTs, GMFRs and seroconversion rates for LT IgG and IgA) of subject self-administered \[second\] vaccination with clinician-administered \[second\] vaccination, using the deltoid/thigh (Vaccination 1/Vaccination 2) treatment regimen. GMT: geometric mean titer
Interventions
- BIOLOGICAL heat-labile enterotoxin of E. coli (LT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2007-11 |
| Est. Completion | 2008-08 |
| Phase | Phase 2 |
What the finished NCT00565461 record still lists
NCT00565461 is an interventional study that assigns participants to a tested intervention. The registered 160 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 (20% higher).
The record links to 0 conditions, and to 1 intervention - of which heat-labile enterotoxin of E. coli (LT) is the first listed.
NCT00565461 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00565461 about?
NCT00565461 is a clinical study titled "LT Vaccine Patch Self-Administration Study". 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.
What is the current status of trial NCT00565461?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2007-11. Estimated completion is 2008-08.
What interventions are being tested in trial NCT00565461?
The interventions under investigation include: heat-labile enterotoxin of E. coli (LT) (BIOLOGICAL).
Who is sponsoring clinical trial NCT00565461?
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 NCT00565461's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 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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