Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197184
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2005-09-15
Brief Title:
Long Term Follow-up Study at Years 2 3 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate the Persistence of Immune Response of GSK Biologicals Twinrix Vaccine Administered According to a 06 Month Schedule and a 016 Month Schedule in Healthy Children Aged Between 1-11 Years at the Time of First Vaccine Dose
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:
To evaluate the persistence of anti-hepatitis A virus HAV and anti-hepatitis B surface antigen HBs antibodies up to 2 3 4 and 5 years after administration of the first dose of the study vaccine
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 randomised self-contained multicentric multinational long-term antibody persistence studies Immune persistence was compared between subjects who received either two dose or three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine The long-term follow-up studies involved taking blood samples at approximately 2 3 4 and 5 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence No additional subjects will be recruited during the long term follow-up period
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 |
|---|---|---|---|
| 208127137 EXT Y5 | OTHER | GSK | None |
| 208127133 EXT Y3 | OTHER | None | None |
| 208127134 EXT Y4 | OTHER | None | None |