Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258817
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2005-11-24
Brief Title:
Phase IV Trial to Collect Safety Data and Sera in Healthy Children Given Fluzone Vaccine
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving 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 provide serum to the Food and Drug Administration FDA for use by FDA the Centers for Disease Control and Prevention CDC and the World Health Organization WHO for characterization of circulating influenza strains
Observational Objectives
To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine given in the two-dose schedule in accordance with the Package Insert in children aged 6 months to 36 months
To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine administered in a two-dose schedule in accordance with the Package Insert in children aged 6 months to 36 months
Observational Objectives
To describe the safety of the 2005-2006 pediatric formulation of Fluzone vaccine given in the two-dose schedule in accordance with the Package Insert in children aged 6 months to 36 months
To describe the immunogenicity of the 2005-2006 pediatric formulation of Fluzone vaccine administered in a two-dose schedule in accordance with the Package Insert in children aged 6 months to 36 months
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