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| Descriptive Information Fields | |||||
| Brief Title † | Safety Evaluation of a Q-Fever Vaccine | ||||
| 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 | ||||
| Brief Summary | 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. |
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety Study | ||||
| Primary Outcome Measure † | The adverse reaction and occupational illness endpoint measurements in this Q fever NDBR 105 vaccine study will be evaluated for all intent-to-treat volunteers. [ Time Frame: AEs recorded through day 28 after vaccination; SAEs recorded through duration of study; Confirmed occupational illness recorded through duration of study ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Q Fever | ||||
| Intervention † | Biological: Q-Fever Vaccine | ||||
| MEDLINE PMIDs | |||||
| Links | |||||
| Recruitment Information Fields | |||||
| Recruitment Status † | Suspended | ||||
| Enrollment † | 500 | ||||
| Start Date † | February 2006 | ||||
| Completion Date | February 2011 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 17 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00584454 | ||||
| Organization ID | A-13480 | ||||
| Secondary IDs †† | FY05-14 | ||||
| Study Sponsor † | U.S. Army Medical Research and Materiel Command | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | U.S. Army Medical Research and Materiel Command | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | December 20, 2007 | ||||
| Last Updated Date | December 20, 2007 | ||||