Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391391
Status:
COMPLETED
Last Update Posted:
2011-12-01
First Post:
2006-10-23
Brief Title:
Study of Inactivated Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Infants and Children
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity and Safety of a Split Inactivated Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone in Healthy Infants and Young Children
Status:
COMPLETED
Status Verified Date:
2011-11
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:
Primary Objective
To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years
Secondary Objectives
To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years
To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years
To evaluate for each influenza strain the non-inferiority of Investigational Fluzone vaccine to the standard Fluzone vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years
Secondary Objectives
To describe the immunogenicity of of Investigational Fluzone vaccine to the standard Fluzone vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years
To describe the safety of of Investigational Fluzone vaccine to the standard Fluzone vaccine in healthy subjects aged 6 to 35 months or 3 to 8 years
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