Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00388583
Status:
COMPLETED
Last Update Posted:
2012-04-18
First Post:
2006-10-16
Brief Title:
Study of Inactivated Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
Immunogenicity and Safety of The Split Inactivated Trivalent Influenza Vaccine Administered by Intradermal Route in Comparison With Intramuscular Vaccination With Standard Fluzone in Ambulatory Elderly Subjects
Status:
COMPLETED
Status Verified Date:
2012-04
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:
As a result of the safety and immunogenicity data generated from earlier dose-ranging studies the present formulation has been selected for further development in the elderly
Primary Objective
To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone
Secondary Objectives
Immunogenicity
To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone
Safety
To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination
Primary Objective
To compare the immunogenicity in subjects receiving investigational Fluzone with those of subjects receiving standard Fluzone
Secondary Objectives
Immunogenicity
To describe the immunogenicity in subjects receiving investigational Fluzone and standard Fluzone
Safety
To evaluate and describe the safety profile of investigational Fluzone in terms of solicited- and unsolicited adverse events and serious adverse events post-vaccination
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