Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-28 @ 10:14 PM
Study NCT ID:
NCT00775450
Status:
COMPLETED
Last Update Posted:
2013-12-31
First Post:
2008-10-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Influenza Vaccine Revaccination in Ambulatory Elderly Subjects
Sponsor:
Sanofi Pasteur, a Sanofi Company
Organization:
Study Overview
Official Title:
Safety and Immunogenicity of Revaccination With Influenza Vaccine in Ambulatory Elderly Subjects Previously Vaccinated With Fluzone ID, Fluzone HD, and Fluzone® IM
Status:
COMPLETED
Status Verified Date:
2013-12
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:
This is a multi-center study designed to evaluate the safety and immunogenicity of a Fluzone revaccination in elderly adults aged ≥ 65 years.
Primary Objective:
To describe the safety profile for all subjects.
Secondary Objective:
To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Primary Objective:
To describe the safety profile for all subjects.
Secondary Objective:
To describe immunogenicity 28 days following revaccination with one of three Fluzone formulations.
Detailed Description:
Subjects who previously participated in study FID29 will be invited to participate in this revaccination study. They will be assigned to 1 of 3 groups based on the group they were previously randomized to and the vaccine received in study FID29.
Study Oversight
Has Oversight DMC:
False
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?: