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NCT00485134 · ClinicalTrials.gov registry record · Phase 1
Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection
A Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
- Completed
- Registry status
- Phase 1
- Development phase
- 113
- Enrollment target
NCT00485134: Completed Phase 1 study, sponsored by U.S. Army Medical Research and Development Command.
NCT00485134 is a Phase 1 study that has completed, run by U.S. Army Medical Research and Development Command. The registered enrollment target is 113 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00485134, a Phase 1 study, has completed, sponsored by U.S. Army Medical Research and Development Command.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 113 participants
- Enrollment target
Study Summary
The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.
Primary Outcome
Fecal samples were collected through day 77 or until discharge (all stools collected for weighing/grading; maximum of 3 stools/day for culture; rectal swab obtained if no stool provided).
Interventions
- BIOLOGICAL 240 µg Shigella flexneri 2a Invaplex 50 vaccine
- BIOLOGICAL 480 µg Shigella flexneri 2a Invaplex 50 vaccine
- BIOLOGICAL 690 Shigella flexneri 2a Invaplex 50 vaccine
- OTHER Shigella challenge strain
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 113 participants |
| Start Date | 2007-05 |
| Est. Completion | 2010-09 |
| Phase | Phase 1 |
What the finished NCT00485134 record still lists
NCT00485134 is an interventional study that assigns participants to a tested intervention. The registered 113 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 4 interventions - of which 240 µg Shigella flexneri 2a Invaplex 50 vaccine is the first listed.
NCT00485134 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00485134 about?
NCT00485134 is a clinical study titled "Shigella Flexneri 2a Invaplex 50 Vaccine Dose Finding and Assessment of Protection". The purpose of this study is to select a safe and immunogenic dose of Invaplex 50 intranasal vaccine, and to assess protection of Invaplex 50 intranasal vaccine against diarrhea, dysentery, and fever following challenge with the Shigella flexneri 2a 2457T strain.
What is the current status of trial NCT00485134?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 113 participants. The study started on 2007-05. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00485134?
The interventions under investigation include: 240 µg Shigella flexneri 2a Invaplex 50 vaccine (BIOLOGICAL), 480 µg Shigella flexneri 2a Invaplex 50 vaccine (BIOLOGICAL), 690 Shigella flexneri 2a Invaplex 50 vaccine (BIOLOGICAL), Shigella challenge strain (OTHER).
Who is sponsoring clinical trial NCT00485134?
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 NCT00485134's enrollment target sits among peer trials
113 508th of 2000 higher than 1,493 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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