Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00383526
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2006-09-29
Brief Title:
Study of Inactivated Split-Virion Influenza Vaccine Compared With the Reference Vaccine Vaxigrip in the Elderly
Sponsor:
Sanofi Pasteur a Sanofi Company
Organization:
Sanofi
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-01
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:
Vaccination against influenza is a high priority for the elderly population who present the highest morbidity and mortality rate However due to their weak antibody response an improvement of the immune response to influenza vaccination remains an unmet medical need The purpose of an investigational influenza vaccine candidate administered by an alternate route is to improve immune responses to the vaccine in the elderly population which could provide additional reductions in influenza-associated morbidity and mortality in this population
Primary Objective
To demonstrate that the investigational vaccine induces a better immunogenicity than the reference vaccine in terms of seroprotection rate after the first vaccination
Secondary Objectives
Immunogenicity
To describe the antibody persistence induced by both vaccines at 3 6 and 12 months after the first vaccination in a subset of subjects
To describe the immunogenicity of the investigational vaccine after each vaccination using parameters defined in the European Medicines Agency EMEA Note for Guidance CPMPBWP21496 specific to elderly subjects
Safety
To demonstrate the tolerance of the investigational vaccine after the first vaccination in terms of pre-defined solicited systemic reactions
To describe the safety profile after each vaccination To describe the effect of repetitive injections on the safety profile
Primary Objective
To demonstrate that the investigational vaccine induces a better immunogenicity than the reference vaccine in terms of seroprotection rate after the first vaccination
Secondary Objectives
Immunogenicity
To describe the antibody persistence induced by both vaccines at 3 6 and 12 months after the first vaccination in a subset of subjects
To describe the immunogenicity of the investigational vaccine after each vaccination using parameters defined in the European Medicines Agency EMEA Note for Guidance CPMPBWP21496 specific to elderly subjects
Safety
To demonstrate the tolerance of the investigational vaccine after the first vaccination in terms of pre-defined solicited systemic reactions
To describe the safety profile after each vaccination To describe the effect of repetitive injections on the safety profile
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