Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380211
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2006-09-21
Brief Title:
Safety and Immunogenicity of FluLaval TR and Fluarix Influenza Vaccines in Young and Older Adults
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-Blind Trial Evaluating the Safety and Immunogenicity of an Influenza Vaccine With Reduced Preservative FluLaval TR and a Standard Influenza Vaccine Fluarix in Subjects Between 18-60 and Over 60 Years of Age
Status:
COMPLETED
Status Verified Date:
2016-10
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:
The purpose of this trial is to describe the immunogenicity the safety and tolerability of FluLaval TR and Fluarix the latter serving as active comparator The results will be compared to a standard immune response criteria for both young and elderly populations
Detailed Description:
This randomized trial will assess the immune protection offered at Day 21 by FluLaval TR Fluarix being the comparator In both groups immune response will be assessed through a blood test before and 21 days following vaccination The safety and tolerability of the study vaccine will be contrasted to the comparator vaccine over a period of 42 days following vaccination
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