Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00318149
Status:
COMPLETED
Last Update Posted:
2018-08-08
First Post:
2006-04-25
Brief Title:
Safety Study of Four Candidate Influenza Vaccines to Prevent Influenza Disease in the Elderly Population
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Demonstrate the Non-inferiority in Term of Cellular Mediated Immune Response of GSK Biologicals Influenza Candidate Vaccines Containing Various Adjuvants Administered in Elderly Population Aged 65 Years Amp Older vs Fluarix Known as Alpha-Rix in Belgium Administered in Adults 18-40 Years
Status:
COMPLETED
Status Verified Date:
2018-02
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:
As influenza vaccine efficacy is reported to be lower in elderly subjects compared to healthy adults probably as a result of immunosenescence there is a desire to devise ways to increase the current vaccines efficacy for this target population Adjuvants are known to boost immune responses thus representing one way to increase the efficacy of the current GlaxoSmithKline Fluarix influenza vaccine in elderly subjects The purpose of this study is to evaluate the immunogenicity and the reactogenicity of a vaccination with four different adjuvanted GlaxoSmithKline influenza vaccines administered to elderly subjects For immunogenicity and safety evaluations healthy adults aged 18 to 40 years old and elderly aged 65 years and older will receive Fluarix and form the control groups of this trial
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