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NCT00097396 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V
A Phase 1 study of Pneumonic Plague and Preventive Therapy, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT00097396 is a Phase 1 study of Pneumonic Plague and Preventive Therapy that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 40 participants. The trial reports 1 study location across 1 state.
The verdict
NCT00097396, a Phase 1 study of Pneumonic Plague and Preventive Therapy, has completed, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and tolerability of a third intramuscular (IM) dose of 160 ug rF1V in healthy volunteers who have previously been vaccinated with the same concentration of rF1V vaccine.
Conditions Studied
Interventions
- BIOLOGICAL rF1V vaccine
Study Locations (1)
Kentucky
- University of Kentucky - Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2004-11 |
| Est. Completion | 2006-09 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00097396
The ClinicalTrials.gov registry entry for NCT00097396 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 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 2 conditions, with Pneumonic Plague appearing as the primary indexed condition, and to 1 intervention - of which rF1V vaccine is the first listed.
NCT00097396 reports 1 study location spanning 1 distinct geographic area - top geographies include Kentucky.
Frequently Asked Questions
What is clinical trial NCT00097396 about?
NCT00097396 is a clinical study titled "Safety, Tolerability & Immunogenicity of the Recombinant Plague Vaccine rF1V". The purpose of this study is to evaluate the safety and tolerability of a two-dose schedule of the recombinant plague vaccine rF1V in healthy volunteers when given as an intramuscular (IM) injection at four ascending dose-levels. The purpose of the Cohort 4 Extension is to evaluate the safety and to...
What is the current status of trial NCT00097396?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2004-11. Estimated completion is 2006-09.
What conditions does trial NCT00097396 study?
This clinical trial studies the following conditions: Pneumonic Plague, Preventive Therapy.
What interventions are being tested in trial NCT00097396?
The interventions under investigation include: rF1V vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT00097396?
This trial is sponsored by DynPort Vaccine Company LLC, A GDIT Company, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00097396 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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