Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2026-02-20 @ 11:19 AM
Study NCT ID:
NCT00514904
Status:
COMPLETED
Last Update Posted:
2020-10-27
First Post:
2007-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 2-10 Year Old Subjects
Sponsor:
GlaxoSmithKline
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2012-000283-23 | EUDRACT_NUMBER | None | View |