Ignite Creation Date:
2025-12-24 @ 1:39 PM
Ignite Modification Date:
2025-12-28 @ 3:30 PM
Study NCT ID:
NCT00711295
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2008-07-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 3 Study of a H5N1 Vaccine in Adults, Elderly and Specified Risk Groups
Sponsor:
Alachua Government Services, Inc.
Organization:
Study Overview
Official Title:
An Open-Label Phase 3 Study to Assess the Safety and Immunogenicity of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in an Adult and Elderly Population as Well as in Specified Risk Groups
Status:
COMPLETED
Status Verified Date:
2010-11
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:
None
Brief Summary:
The purpose of this study is to assess the safety and tolerability of, and the immune response to a non-adjuvanted H5N1 influenza vaccine in an adult and elderly population and in specified risk groups. Furthermore, persistence of H5N1 influenza antibodies after vaccination with this vaccine will be assessed.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: