Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00508261
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2007-07-26
Brief Title:
Co-Administration of Meningococcal Vaccine GSK134612 With Infanrix Hexa Versus Individual Administration of Each Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
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:
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