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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: | NCT00582088 |
The study is designed to assess the safety and immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination.
Condition | Intervention | Phase |
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Venezuelan Equine Encephalomyelitis |
Biological: VEE C-84 |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Site Phase 2 Open-Label, Safety and Immunogenicity Study of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205 When Used as a Booster After TC-83 Primary Immunization in Healthy Adults At Risk for Exposure to Virulent Venezuelan Equine Encephalomyelitis Virus |
Estimated Enrollment: | 500 |
Study Start Date: | January 2008 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Study Objectives:
Primary:
To assess safety of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series, and To assess immunogenicity of Venezuelan Equine Encephalomyelitis Vaccine, Inactivated, Dried, C-84, TSI GSD 205, as a booster vaccination as a single dose or a three-dose series
Secondary:
To assess incidence of VEE infection in C-84 boosted personnel.
Ages Eligible for Study: | 17 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Ellen Boudreau | 301-619-4639 | ellen.boudreau@amedd.army.mil |
Contact: Diane Ullman | 301-619-4828 | diane.ullman@amedd.army.mil |
United States, Maryland | |
U.S. Army Medical Research Institute of Infectious Diseases | Recruiting |
Fort Detrick, Maryland, United States, 21702 |
Principal Investigator: | Ellen F Boudreau, 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-14350, FY06-27 |
Study First Received: | December 19, 2007 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00582088 |
Health Authority: | United States: Food and Drug Administration |
Encephalitis, Viral Infections, Neurologic diseases, Alphavirus Infections, VEE |
Virus Diseases Central Nervous System Infections Encephalomyelitis, Equine Central Nervous System Diseases Encephalomyelitis Healthy |
Arbovirus Infections Brain Diseases Encephalomyelitis, Venezuelan Equine Togaviridae Infections Encephalitis |
Encephalitis, Viral RNA Virus Infections Nervous System Diseases Alphavirus Infections Central Nervous System Viral Diseases |