Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-30 @ 5:11 AM
Study NCT ID:
NCT00606359
Status:
COMPLETED
Last Update Posted:
2014-01-14
First Post:
2008-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine in Renal Transplant Subjects
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Immunogenicity of the Inactivated Split-Virion Influenza Vaccine Administered by the Intradermal Route in Renal Transplant Subjects
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:
Primary Objective:
To describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®).
Secondary Objective:
To describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine
To describe the immunogenicity of an injection of the investigational inactivated, split-virion influenza vaccine 21 days after vaccination in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine (Vaxigrip®).
Secondary Objective:
To describe the safety of an injection of the investigational inactivated, split-virion influenza vaccine in 18 to 60 years old renal transplant subjects identified as non-responder to previous vaccination with the IM reference vaccine
Detailed Description:
The trial is a multicenter, randomized, controlled trial in renal transplant subjects aged 18 to 60 years who are non-responders to vaccination with the reference vaccine. Subjects will be randomized to receive either the 2007-2008 15 µg investigational vaccine or the 2007-2008 IM reference vaccine.
Study Oversight
Has Oversight DMC:
True
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?: