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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00485134
The ClinicalTrials.gov registry entry for NCT00485134 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 113 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is U.S. Army Medical Research and Development Command, which has 77 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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