Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00197171
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2005-09-14
Brief Title:
Long Term FU Studies at Y56 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A B Vaccine
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate the Persistence of Immune Response of GSK Biologicals TWINRIX ADULT Administered According to 06 Month Schedule and 012 Month Schedule in Volunteers Aged 12-15 Years Inclusive at the Time of First Vaccine Dose
Status:
COMPLETED
Status Verified Date:
2016-09
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 immune response 5 years and 6 years after the first vaccine dose
Detailed Description:
Open randomised long-term antibody persistence studies conducted in 2 centers Immune persistence was compared between subjects who received two doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine at either 0 6 month schedule or 0 12 month schedule These long-term follow-up studies involved taking blood samples at approximately 5 and 6 years after the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence and a retrospective safety follow-up
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 |
|---|---|---|---|
| 100387 | None | None | None |