Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00517517
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2007-08-16
Brief Title:
Safety and Immunogenicity Study of Two Doses of an Inactivated H5N1 Influenza Vaccine Whole Virion Vero Cell Derived
Sponsor:
Resilience Government Services Inc
Organization:
Resilience Government Services Inc
Study Overview
Official Title:
An Open-Label Phase III Study to Assess the Safety and Immunogenicity of Two Doses of a Vero Cell Derived Whole Virus Clade 2 H5N1 Influenza Vaccine in Healthy Volunteers Aged 21 to 45 Years
Status:
COMPLETED
Status Verified Date:
2011-09
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 objectives of this Phase III study are to assess the safety and immunogenicity of two different dose levels of a non-adjuvanted H5N1 influenza vaccine in a healthy young adult population Subjects will be randomized 11 to receive two intramuscular injections 21 days apart of the vaccine containing either 375 µg or 75 µg H5N1 hemagglutinin HA antigen in a non-adjuvanted formulation Subjects will be monitored for safety and for antibody response to the vaccine A data safety monitoring board will review the safety data after the first and second vaccination
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None