Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2026-01-03 @ 9:31 PM
Study NCT ID:
NCT01266993
Status:
COMPLETED
Last Update Posted:
2020-11-23
First Post:
2010-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Persistence and Booster Study of GSK Biologicals' Meningococcal Vaccine (GSK134612) in Healthy Children
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Persistence of Antibodies After Vaccination With a Dose of GSK Biologicals' Meningococcal Vaccine GSK134612 in Healthy Children and Safety and Immunogenicity of a Booster Dose at 68 Months Post-primary Vaccination
Status:
COMPLETED
Status Verified Date:
2020-11
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 the study is to evaluate the persistence of the immune response of GSK134612 vaccine up to 68 months after vaccination in the primary vaccination study (NCT number = NCT00674583) of 2 to 10 year old subjects. This study will also evaluate the safety and immunogenicity of a booster dose of GSK134612 vaccine subjects who were primed in the primary vaccination study with either GSK134612 vaccine or Menjugate®.
This protocol posting deals with objectives \& outcome measures of the persistence and booster epochs. The objectives \& outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)
This protocol posting deals with objectives \& outcome measures of the persistence and booster epochs. The objectives \& outcome measures of the primary epoch are presented in a separate protocol posting (NCT number = NCT00674583)
Detailed Description:
Subjects were previously vaccinated at 2 to 10 years of age with GSK134612 or with Menjugate®. The persistence phase starts 32 months after the primary vaccination and blood samples will be taken at 32, 44, 56 and 68 months after primary vaccination. All subjects will receive a booster dose of GSK134612 at 68 months after primary vaccination and a blood sample will be taken 1 month after administration of the booster dose.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2010-018730-51 | EUDRACT_NUMBER | None | View |