Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00514904
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2007-08-09
Brief Title:
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax in 2-10 Year Old Subjects
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Non-inferiority of GSK Biologicals Meningococcal Vaccine GSK134612 Versus Mencevax in Healthy Subjects Aged 2 Through 10 Years of Age
Status:
COMPLETED
Status Verified Date:
2020-09
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 demonstrate in 2-10 year old subjects the non-inferiority of meningococcal vaccine GSK134612 compared to licensed meningococcal vaccine Mencevax
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
Detailed Description:
Multicentre study with 2 treatment groups Two blood samples will be taken prior to and one month after vaccination from the first 75 enrolled subjects per country independent of the treatment group
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 |
|---|---|---|---|
| 2012-000283-23 | EUDRACT_NUMBER | None | None |