Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258934
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2005-11-24
Brief Title:
Immunogenicity Study of the Influenza Vaccine in Adults
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 IM route This study will test whether an influenza vaccine is effective when injected by a route other 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 In addition the safety of both influenza vaccines administered by different routes will be tested by evaluating all adverse events and especially all serious reactions
Primary Objective To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes
Secondary Objectives To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency EMEA after the first injection
Primary Objective To demonstrate and compare the immune response of an influenza vaccine after a single dose when administered by different routes
Secondary Objectives To describe the compliance of the immunogenicity of the vaccine with the European Medicine Agency EMEA after the first injection
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