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Sponsored by: |
U.S. Army Medical Research and Materiel Command |
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Information provided by: | U.S. Army Medical Research and Materiel Command |
ClinicalTrials.gov Identifier: | NCT00584454 |
The purpose of this study is to evaluate the safety of Q Fever vaccine, NDBR 105, and collect data on incidence of occupational Q Fever infection in at risk personnel.
Condition | Intervention | Phase |
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Q Fever |
Biological: Q-Fever Vaccine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety Study |
Official Title: | Continued Evaluation of the Safety of Q Fever Vaccine, Phase I, Inactivated, Freeze Dried, NDBR 105, in Those at Risk of Exposure to Coxiella Burnetii, A Phase 2 Study |
Estimated Enrollment: | 500 |
Study Start Date: | February 2006 |
Estimated Study Completion Date: | February 2011 |
Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
Study Objectives:
1. Continue to collect and assess safety data on Q Fever Vaccine, Phase I, Inactivated, Freeze-Dried, NDBR 105, and 2) Provide vaccine that potentially protects personnel at risk for occupational exposure to Q Fever and collect data on incidence of occupational Q Fever infection (subclinical and clinical) in immunized personnel.
Ages Eligible for Study: | 17 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, Maryland | |
U.S. Army Medical Research Institute of Infectious Diseases | |
Fort Detrick, Maryland, United States, 21702 |
Principal Investigator: | Robert Rivard, MD | USAMRIID Medical Division |
Responsible Party: | USAMRMC, USAMMDA ( Robert E. Miller, PhD, Sponsor Representative, Director, Division of Regulated Activities and Compliance ) |
Study ID Numbers: | A-13480, FY05-14 |
Study First Received: | December 20, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00584454 |
Health Authority: | United States: Food and Drug Administration |
Coxiella burnetti, Bacterial Infections, Rickettsia, Hepatits, Endocarditis |
Fever Bacterial Infections Signs and Symptoms Q Fever |
Q fever Gram-Negative Bacterial Infections Endocarditis |
Body Temperature Changes |