Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197288
Status:
COMPLETED
Last Update Posted:
2017-01-18
First Post:
2005-09-19
Brief Title:
Study Comparing the Immune Response of Fluarix and Fluzone Influenza Vaccines
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase III Observer-blind Randomized Study to Evaluate the Immunogenicity and Safety of Fluarix GlaxoSmithKline Biologicals Compared With Fluzone Aventis Pasteur Administered Intramuscularly in Adults 18 Years and Older in the US
Status:
COMPLETED
Status Verified Date:
2017-01
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:
The purpose of this study is to compare two licensed influenza vaccines Fluzone and Fluarix in terms of the immune response elicited and the safety any symptoms that may occur for up to six months after vaccination
Detailed Description:
Experimental design multi-center randomized 11 observer-blind active-controlled study in 2 parallel groups with approximately
Study vaccine full dose of Fluarix by IM administration
Control vaccine full dose of Fluzone by IM administration
Two scheduled visits per subject at days 0 visit 1 and 21visit 2 with blood sample collected at each visit to evaluate the immune response There will be a final contact with each subject 6 months after vaccination for safety follow up and study conclusion
Vaccination schedule one IM injection at day 0
Type of study Self contained
Study vaccine full dose of Fluarix by IM administration
Control vaccine full dose of Fluzone by IM administration
Two scheduled visits per subject at days 0 visit 1 and 21visit 2 with blood sample collected at each visit to evaluate the immune response There will be a final contact with each subject 6 months after vaccination for safety follow up and study conclusion
Vaccination schedule one IM injection at day 0
Type of study Self contained
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