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NCT01122784 · ClinicalTrials.gov registry record · Phase 2
Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant
A Phase 2 study of Plague Vaccine, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 402
- Enrollment target
- 11
- Study locations
NCT01122784 is a Phase 2 study of Plague Vaccine that has completed, run by DynPort Vaccine Company LLC, A GDIT Company. The registered enrollment target is 402 participants. The trial reports 11 study locations across 9 states.
The verdict
NCT01122784, a Phase 2 study of Plague Vaccine, has completed, sponsored by DynPort Vaccine Company LLC, A GDIT Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 402 participants
- Enrollment target
- 11
- Study locations
Study Summary
Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vaccinated at two different three-dose schedules (Days 0, 56 and 182 or Days 0, 56 and 121).
Conditions Studied
Interventions
- BIOLOGICAL rF1V vaccine (with Adjuvant)
- BIOLOGICAL rF1V vaccine (without Adjuvant)
Study Locations (11)
California
- Benchmark Research - San Francisco
- Apex Research Institute - Santa Ana
Kansas
- Johnson County Clinical Trials - Lenexa
- Heartland Reseach Assoicates, LLC - Wichita
Kentucky
- Central Kentucky Research Associates - Lexington
Maryland
- WRAIR Clinical Trials Center - Silver Spring
Missouri
- Center for Pharmceutical Research - Kansas City
New York
- Rochester Clinical Research - Rochester
North Carolina
- Wake Research Associates - Raleigh
South Carolina
- Coastal Carolina Research Center - Mt. Pleasant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 402 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01122784
The ClinicalTrials.gov registry entry for NCT01122784 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 402 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 1 condition, with Plague Vaccine appearing as the primary indexed condition, and to 2 interventions - of which rF1V vaccine (with Adjuvant) is the first listed.
NCT01122784 reports 11 study locations spanning 9 distinct geographic areas - top geographies include California, Kansas, Kentucky.
Frequently Asked Questions
What is clinical trial NCT01122784 about?
NCT01122784 is a clinical study titled "Randomized Single-Blinded Study to Evaluate Safety and Immunogenicity of Recombinant Plague Vaccine With and Without Adjuvant". Multicenter, randomized, single-blinded comparison of two formulations of the rF1V vaccine at a single dosage of 80 µg and two 3-dose schedules in 400 healthy, adult volunteers in four parallel cohorts. Two rF1V vaccine cohorts (N=160 each) and two rF1V antigen-only cohorts (N=40 each) will be vacci...
What is the current status of trial NCT01122784?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 402 participants. The study started on 2010-07. Estimated completion is 2012-07.
What conditions does trial NCT01122784 study?
This clinical trial studies the following conditions: Plague Vaccine.
What interventions are being tested in trial NCT01122784?
The interventions under investigation include: rF1V vaccine (with Adjuvant) (BIOLOGICAL), rF1V vaccine (without Adjuvant) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01122784?
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 NCT01122784 being conducted?
This trial has 11 study locations across California, Kansas, Kentucky, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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