Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474266
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2007-05-15
Brief Title:
Safety Immunogenicity Study of Meningococcal Vaccine GSK134612 Given With Priorix-Tetra to 12-23 Month-Old Children
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Immunogenicity Safety Study of GSK Biologicals Meningococcal Vaccine GSK134612 When Co-Administered With GSK Biologicals MMRV Vaccine Priorix-Tetra in Healthy 12 to 23-Month-Old Children
Status:
COMPLETED
Status Verified Date:
2019-11
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 month old children the non-inferiority of the meningococcal vaccine 134612 given with Priorix-Tetra
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:
Open multicentre study with 4 treatment groups Two groups will receive the 134612 vaccine with Priorix-Tetra either at the same or different visits followed by a second Priorix-Tetra vaccination at 84 days
Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days
For all subjects two blood samples will be taken prior to and 42 days after the first vaccination In a subset 30 of subjects in Groups A en C from selected study centres additional sample 42 days after second Priorix-Tetra dose
Two control groups will receive Priorix-Tetra and Meningitec at different visits followed by a second Priorix-Tetra vaccination at 84 days
For all subjects two blood samples will be taken prior to and 42 days after the first vaccination In a subset 30 of subjects in Groups A en C from selected study centres additional sample 42 days after second Priorix-Tetra dose
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 |
|---|---|---|---|
| 2006-006580-23 | EUDRACT_NUMBER | None | None |