Ignite Creation Date:
2024-05-05 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296829
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2006-02-24
Brief Title:
Immunogenicity of Two Dosages of Inactivated Split-Virion Influenza Vaccine Given by an Alternate Route 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:
All marketed influenza vaccines are injected by the intramuscular route This study will test whether an influenza vaccine is effective when injected by other route than into the muscle In order to prove this the amount of antibodies in the blood will be measured before and after vaccination In addition the safety of both influenza vaccines will be tested by evaluating all serious reactions occurring after vaccination The vaccine injected in this study is similar to the sponsors marketed intramuscular influenza vaccine Vaxigrip
Primary Objective
To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine
Secondary Objectives
To compare the immune response 21 days after vaccination between each investigational group versus intramuscular group for each influenza strain
To describe the safety profile after the vaccination in each study group
To describe the compliance of the two dosages of the vaccine administered by the alternate route with the European Medicine Agency
Observational Objectives
To describe the safety profile during the 21-day period following an intramuscular revaccination in each group and the possibility of any reaction at the first injection site
To describe the pain at the injection site with a Visual Analog Scale and the acceptability of the injection using a questionnaire in each group
To describe the leakage appearing at the injection site immediately after the alternate route injection and to explore the relationship with immunogenicity
To evaluate the cellular mediated immune response in a subset of subjects
Primary Objective
To demonstrate and compare the immune response of two dosages of influenza vaccine administered by an alternate route to the intramuscular administration of the vaccine
Secondary Objectives
To compare the immune response 21 days after vaccination between each investigational group versus intramuscular group for each influenza strain
To describe the safety profile after the vaccination in each study group
To describe the compliance of the two dosages of the vaccine administered by the alternate route with the European Medicine Agency
Observational Objectives
To describe the safety profile during the 21-day period following an intramuscular revaccination in each group and the possibility of any reaction at the first injection site
To describe the pain at the injection site with a Visual Analog Scale and the acceptability of the injection using a questionnaire in each group
To describe the leakage appearing at the injection site immediately after the alternate route injection and to explore the relationship with immunogenicity
To evaluate the cellular mediated immune response in a subset of subjects
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