Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-27 @ 10:51 PM
Study NCT ID:
NCT00584194
Status:
COMPLETED
Last Update Posted:
2020-01-03
First Post:
2007-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Immunogenicity Study of Rift Valley Fever Vaccine
Sponsor:
U.S. Army Medical Research and Development Command
Organization:
Study Overview
Official Title:
Parts A&B: Evaluation of the Safety and Immunogenicity of Rift Valley Fever Vaccine, Inactivated, Dried (TSI-GSD 200), A Phase 2 Study
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RVF
Brief Summary:
This study is designed to determine the safety and immunogenicity of a Rift Valley Fever (RVF) Vaccine
Detailed Description:
Study Objectives:
The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.
The objectives of this two-part, primary immunization and booster dose, study are to continue to collect safety data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200); and, to continue to collect immunogenicity data on Rift Valley Fever (RVF) Vaccine, Inactivated (TSI-GSD 200) and analyze interim data to determine whether a 6-month dose is indicated; and, to provide potential protection for personnel at risk for occupational exposure to the RVF virus and collect data on incidence of occupational RVF infection (subclinical and clinical) in immunized personnel.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| FY03-05 | OTHER | SIP | View |