Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00464815
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2007-04-23
Brief Title:
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax in 11-17 Year-Old Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Primary Vaccination Study in Subjects Aged 11-17 Years to Demonstrate the Non-inferiority of GSK Biologicals Meningococcal Vaccine GSK134612 Vaccine Versus Mencevax ACWY
Status:
COMPLETED
Status Verified Date:
2018-03
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 demonstrate in 11-17 year old subjects the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax
Detailed Description:
Multicentre study with 2 treatment groups Each subject will have 2 blood samples taken for immunogenicity analyses one prior to vaccination and one taken 30 days later
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