Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227422
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-09-26
Brief Title:
Assess the Non-inferiority of GSK Biologicals Mencevax ACWY Manufactured by a New Process vs Mencevax ACWY the Already Existing Vaccine in the Market When Given as a Single Dose to Subjects Aged 2-30 Yrs
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase IV Partially Double-blind Study to Demonstrate Non-inferiority of GSK Biologicals Mencevax ACWY New Process Versus Mencevax ACWY Current Process When Administered as a Single Dose to Subjects Aged 2-30 Yrs
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 that the vaccine produced with the new process and administered as a single dose is at least as good as the existing Mencevax ACWY vaccine in terms of immunogenicity safety and reactogenicity in healthy subjects aged 2-30 years
Detailed Description:
Randomized study with four groups to receive one of the following vaccination regimens - One of the 3 lots of GSK Biologicals Mencevax ACWY vaccine manufactured by the new process 3 different groups - GSK Biologicals already existing Mencevax ACWY
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