Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-30 @ 10:26 PM
Study NCT ID:
NCT00389857
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2006-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial to Collect Safety Data and Sera for Immunogenicity Testing
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Fluzone® Influenza Virus Vaccine (2006-2007 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 Centers for Biologics Evaluation and Research (CBER) with sera collected from healthy children receiving the 2006-2007 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Center for Disease Control and Prevention (CDC) and World Health Organization (WHO).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: