Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00465816
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2007-04-24
Brief Title:
Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals Meningococcal Vaccine 134612
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Non-inferiority of GSK Biologicals Meningococcal Vaccine 134612 Given Concomitantly With GSK Biologicals Twinrix Versus 134612 Alone and Twinrix Alone in Healthy Subjects Aged 11 Through 17 Years
Status:
COMPLETED
Status Verified Date:
2016-11
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:
This study will demonstrate the non-inferiority of GSK Biologicals meningococcal vaccine 134612 when given in an experimental co-administration versus vaccine 134612 alone and versus the experimental co-administration alone in healthy subjects aged 11 through 17 years There will be 3 groups in this study
Detailed Description:
All subjects of groups A and B will have 4 blood samples taken all subjects of group C will have 3 blood samples taken
The Protocol Posting has been updated in order to comply with the FDA Amendment Act September 2007
The Protocol Posting has been updated in order to comply with the FDA Amendment Act September 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