Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00390143
Status:
COMPLETED
Last Update Posted:
2016-10-25
First Post:
2006-10-17
Brief Title:
Study in AdolescentsAdults to Evaluate the Persistence up to 35 Yrs of GSK Biologicals Meningococcal Vaccine 134612
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Assess Long Term Persistence of a Primary Dose of GSK Biologicals Meningococcal Vaccine 134612 Versus One Dose of Mencevax ACWY in Healthy AdolescentsYoung Adults 15 to 19 Years at Vaccination
Status:
COMPLETED
Status Verified Date:
2016-10
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:
This study will investigate the long-term protection offered by GSK Biologicals meningococcal vaccine 134612 up to 35 years after vaccination Subjects were vaccinated at 15 to 19 years of age This extension phase starts 18 months after vaccination and part of the subjects who were vaccinated in the primary study will be enrolled in this extension phase No new subjects will be enrolled This protocol posting deals with objectives outcome measures of the extension phase 18 30 and 42 months after vaccination The objectives outcome measures of the primary phase are presented in a separate protocol posting NCT00126945 The Protocol Posting has been updated in order to comply with the FDA Amendment Act September 2007
Detailed Description:
Subjects were previously vaccinated at 15 to 19 years of age with GSK Biologicals meningococcal vaccine 134612 or with Mencevax ACWY This extension phase starts 18 months after vaccination and part of the subjects will be enrolled in this extension phase No additional vaccines will be administered during this study and no new subjects will be enrolled The subjects will have three blood samples taken at 18 30 and 42 months 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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 108598 | OTHER | GSK | None |
| 108596 | OTHER | None | None |