Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197119
Status:
COMPLETED
Last Update Posted:
2017-04-20
First Post:
2005-09-14
Brief Title:
Long-Term Follow-Up Studies at Year 6 7 8 9 10 2 Formulations of Combined Hepatitis AB Vaccine Compared in Subjects Aged 12-15 Years
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate Persistence of Immune Response of GSK Biologicals TWINRIX Vaccine Administered According to 06 Month Schedule Versus TWINRIX JUNIOR Administered According to 016 Month Schedule in Subjects Aged 12-15 Years at Time of First Vaccine Dose
Status:
COMPLETED
Status Verified Date:
2017-03
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:
To evaluate the persistence of anti-hepatitis A virus anti-HAV and anti-hepatitis B surface antigen anti-HBs antibodies up to 6 7 8 9 and 10 years after administration of the first dose of the study vaccine
Detailed Description:
Open randomized long-term antibody persistence studies Immune persistence was compared between subjects who received one of the two formulations of GlaxoSmithKline Biologicals combined hepatitis A and hepatitis B vaccine according to a two-dose or three-dose schedule These long-term follow-up studies involved taking blood samples at approximately 6 7 8 9 and 10 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence and a retrospective safety follow-up
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
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 |
|---|---|---|---|
| 100570 | OTHER | GSK | None |
| 100567 | OTHER | None | None |
| 100568 | OTHER | None | None |
| 100569 | OTHER | None | None |