Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258830
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2005-11-24
Brief Title:
Safety and Immunogenicity of the 2005-2006 Fluzone Vaccine
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Annual Study of Safety and Immunogenicity of Fluzone Influenza Virus Vaccine 2005-2006 Formulation
Status:
COMPLETED
Status Verified Date:
2016-04
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:
To describe the safety during Days 0 to 21 following injection of the 2005-2006 formulation of the inactivated split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged 60 years
To describe the immune response antibodies to hemagglutinin 21 days following injection of the 2005-2006 formulation of the inactivated split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged 60 years
To submit remaining available sera to the Center for Biologics Evaluation and Research CBER for further analysis by the Food and Drug Administration FDA Center for Disease Control and Prevention CDC and the World Health Organization WHO to support selection and recommendation of antigen strains for subsequent influenza vaccines
To describe the immune response antibodies to hemagglutinin 21 days following injection of the 2005-2006 formulation of the inactivated split-virion influenza vaccine Fluzone in subjects aged 18-59 years and subjects aged 60 years
To submit remaining available sera to the Center for Biologics Evaluation and Research CBER for further analysis by the Food and Drug Administration FDA Center for Disease Control and Prevention CDC and the World Health Organization WHO to support selection and recommendation of antigen strains for subsequent influenza vaccines
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