Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00349141
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2006-07-05
Brief Title:
Safety and Immunogenicity Study 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:
A Phase III Dose Escalation Study of a Vero Cell-Derived Whole Virus H5N1 Influenza Vaccine in Healthy Volunteers Aged 18 to 45 Years
Status:
COMPLETED
Status Verified Date:
2007-10
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 objective of this study is to assess the safety and immunogenicity of 4 different doses of adjuvanted and non-adjuvanted mock-up pandemic influenza vaccine Subjects will be enrolled sequentially into 3 study cohorts with 4 escalating doses of H5N1 hemagglutininin antigen 375 µg adjuvanted 75 µg adjuvantednon-adjuvanted 15 µg adjuvantednon-adjuvanted 30 µg adjuvanted Starting with the lowest dose level subjects will receive 2 vaccinations 21 days apart at the dose to which they were assigned Subjects will be monitored for safety and for antibody response to the vaccine A data safety monitoring board will review and evaluate all the safety data obtained for a dose level before allowing administration of the next higher dose
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