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NCT01150695 · ClinicalTrials.gov registry record · Phase 2
Phase II Tularemia Vaccine Comparison
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 228
- Enrollment target
NCT01150695 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 228 participants.
The verdict
NCT01150695, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 228 participants
- Enrollment target
Study Summary
The purpose of this study is to compare 2 experimental vaccines that could provide protection from the disease, tularemia. This research will compare the ability of the vaccines to cause the body to develop an immune (protective) response and obtain more information on side effects of the vaccines. About 220 male and non-pregnant female volunteers 18 to 45 years will participate. Volunteers will be assigned to 1 of 2 vaccine groups by chance. About half of the volunteers will be placed in the DVC-LVS vaccine group and half of volunteers will be placed in the USAMRIID-LVS vaccine group. Additionally, both groups will receive an injection of placebo (inactive salt water). Study procedures include physical exam and blood and urine samples. Evaluation of the vaccination sites will be performed as well as blood samples to measure the body's response to the vaccine. Participants will be involved in the study for about 6 months.
Interventions
- OTHER Placebo
- BIOLOGICAL Undiluted Francisella tularensis live attenuated vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 228 participants |
| Start Date | 2010-09 |
| Est. Completion | 2012-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01150695
The ClinicalTrials.gov registry entry for NCT01150695 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 228 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01150695 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01150695 about?
NCT01150695 is a clinical study titled "Phase II Tularemia Vaccine Comparison". The purpose of this study is to compare 2 experimental vaccines that could provide protection from the disease, tularemia. This research will compare the ability of the vaccines to cause the body to develop an immune (protective) response and obtain more information on side effects of the vaccines. ...
What is the current status of trial NCT01150695?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 228 participants. The study started on 2010-09. Estimated completion is 2012-01.
What interventions are being tested in trial NCT01150695?
The interventions under investigation include: Placebo (OTHER), Undiluted Francisella tularensis live attenuated vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT01150695?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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