Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2026-02-27 @ 10:06 AM
Study NCT ID:
NCT00508261
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2007-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa™ Versus Individual Administration of Each Vaccine
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix Hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children
Status:
COMPLETED
Status Verified Date:
2017-05
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 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 co-administered with Infanrix hexa™, compared to each vaccine administered individually and to licensed meningococcal vaccine Meningitec™.
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 4 parallel groups. One group will receive GSK134612 co-administered with Infanrix hexa™, two groups will receive sequential administration of GSK134612 and Infanrix hexa™ and the final group will receive Meningitec™.
For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination.
For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.
For subjects in Groups B and C, three blood samples will be taken: prior to first vaccination and 1 month after each vaccination.
For subjects in Groups A and D, two blood samples will be taken: prior to and 1 month after vaccination.
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?: