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NCT00057525 · ClinicalTrials.gov registry record · Phase 1
A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults
A Phase 1 study, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT00057525 is a Phase 1 study that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 70 participants.
The verdict
NCT00057525, a Phase 1 study, has completed, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with phosphate-buffered saline (PBS) or adsorbed to Alhydrogel.
Interventions
- BIOLOGICAL Anthrax
- BIOLOGICAL Alhdryogel or PBS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2003-04 |
| Est. Completion | 2004-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00057525
The ClinicalTrials.gov registry entry for NCT00057525 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is DynPort Vaccine Company LLC, A GDIT Company, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Anthrax is the first listed.
NCT00057525 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00057525 about?
NCT00057525 is a clinical study titled "A New Anthrax Vaccine Administered by the Intramuscular (IM) Route in Healthy Adults". This study will provide preliminary safety and comparative immunogenicity data for the E.coli derived rPA vaccine administered by intramuscular (IM) injection at Day 0 and Month 1.Doses will range from 5 μg to 100 μg rPA, and at each dose-level, rPA will either be combined with phosphate-buffered sa...
What is the current status of trial NCT00057525?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2003-04. Estimated completion is 2004-08.
What interventions are being tested in trial NCT00057525?
The interventions under investigation include: Anthrax (BIOLOGICAL), Alhdryogel or PBS (BIOLOGICAL).
Who is sponsoring clinical trial NCT00057525?
This trial is sponsored by DynPort Vaccine Company LLC, A GDIT Company, which has 7 total clinical trials registered on ClinicalTrials.gov.
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