Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321373
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2006-03-16
Brief Title:
Study to Evaluate an Influenza Vaccine Candidate
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Study to Demonstrate the Non-Inferiority of Influenza Vaccine Candidate Compared With Fluarix Administered Intramuscularly in Elderly Aged 60 Years Old and Above
Status:
COMPLETED
Status Verified Date:
2016-09
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 evaluate the immune response and safety of influenza vaccine candidate with or without adjuvant compared to Fluarix administered intramuscularly in elderly aged 60 years old and above
Detailed Description:
Subjects will be randomized into 3 groups and will be followed for 6 months with 4 scheduled contacts per subjects The immune response will be evaluated at days 0 21 and 180 after vaccination The safety evaluation will involve follow-up of solicited local and general signs and symptoms unsolicited adverse events and serious adverse events
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 107191 | OTHER | GSK | None |