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NCT00332956 · ClinicalTrials.gov registry record · Phase 2
Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers
A Phase 2 study, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
NCT00332956 is a Phase 2 study that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 400 participants.
The verdict
NCT00332956, a Phase 2 study, has completed, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
Study Summary
This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center study to select a dosage and schedule of rF1V vaccine for further studies based on the immune response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be collected through Day 540. Selection of dosage and schedule will be based on GMCs and seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400 healthy adult volunteers will be enrolled (100 per group) in this study.
Interventions
- BIOLOGICAL rF1V vaccine
- BIOLOGICAL rFIV vaccine
- BIOLOGICAL rF1V vaccine 160 mcg given on Study Days 0, 56, 182
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2006-05 |
| Est. Completion | 2008-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00332956
The ClinicalTrials.gov registry entry for NCT00332956 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 400 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 3 interventions - of which rF1V vaccine is the first listed.
NCT00332956 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00332956 about?
NCT00332956 is a clinical study titled "Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers". This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center study to select a dosage and schedule of rF1V vaccine for further studies based on the immune response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be collected through Day 54...
What is the current status of trial NCT00332956?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2006-05. Estimated completion is 2008-10.
What interventions are being tested in trial NCT00332956?
The interventions under investigation include: rF1V vaccine (BIOLOGICAL), rFIV vaccine (BIOLOGICAL), rF1V vaccine 160 mcg given on Study Days 0, 56, 182 (BIOLOGICAL).
Who is sponsoring clinical trial NCT00332956?
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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