Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00391053
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
2006-10-20
Brief Title:
Immunogenicity of High-dose Inactivated Split-virion Influenza Vaccine Versus Standard Fluzone Vaccine in the Elderly
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
Phase III Lot Consistency Immunogenicity and Safety Study of Three Lots of Fluzone High Dose Vaccine Compared With One Lot of Standard Fluzone in Adults 65 Years of Age
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:
Compared to young adults the elderly mount a lower antibody response to vaccination Thus improvement of the immune response to influenza vaccination in this age group which is at higher risk for influenza-related morbidity and mortality represents an important unmet need
Primary Objectives
Immunogenicity
To demonstrate lot consistency of the Fluzone High Dose Fluzone HD manufacturing process through evaluation of the immune responses elicited by three different lots
To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone vaccine
Secondary Objectives
Immunogenicity
To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone vaccine
Safety
To describe the safety profile of Fluzone HD in terms of solicited - unsolicited adverse and serious adverse events post-vaccination
To describe clinical information on some additional defined criteria during the six months following vaccination
Primary Objectives
Immunogenicity
To demonstrate lot consistency of the Fluzone High Dose Fluzone HD manufacturing process through evaluation of the immune responses elicited by three different lots
To demonstrate the superiority of Fluzone HD vaccine compared to standard-dose Fluzone vaccine
Secondary Objectives
Immunogenicity
To describe the seroprotection of Fluzone HD compared to that of standard dose Fluzone vaccine
Safety
To describe the safety profile of Fluzone HD in terms of solicited - unsolicited adverse and serious adverse events post-vaccination
To describe clinical information on some additional defined criteria during the six months following 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