Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine
Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT00197171
Collaborator
(none)
143
2
3
71.5
23.9
Study Details
Study Description
Brief Summary
To evaluate the persistence of immune response 5 years and 6 years after the first vaccine dose.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Study Type:
Interventional
Actual Enrollment
:
143 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Evaluate the Persistence of Immune Response of GSK Biologicals' TWINRIX™ ADULT, Administered According to 0,6 Month Schedule and 0,12 Month Schedule, in Volunteers Aged 12-15 Years Inclusive at the Time of First Vaccine Dose
Study Start Date
:
Sep 1, 2003
Actual Primary Completion Date
:
Dec 1, 2003
Actual Study Completion Date
:
Dec 1, 2003
Outcome Measures
Primary Outcome Measures
- Immune persistence in terms of anti-HAV and anti-HBs antibodies and GMCs, 5 and 6 years after administration of first vaccine dose. An additional dose of the study vaccine will be given (between 6 to 12 months after the Year 6 time point) to subjects who []
Secondary Outcome Measures
- To record the SAEs that was reported since the last time point. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
12 Years
to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Subjects who received GSK Biologicals' combined hepatitis A and B vaccine in the primary study (HAB-082). Subjects were aged 12 to 15 years at the time of the first vaccination.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | GSK Investigational Site | Paramatta | New South Wales | Australia | 2124 |
| 2 | GSK Investigational Site | Melbourne | Victoria | Australia | 3001 |
Sponsors and Collaborators
- GlaxoSmithKline
Investigators
- Study Director: GSK Clinical Trials, GlaxoSmithKline
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00197171
Other Study ID Numbers:
- 100386 (EXT Y5)
- 100387
First Posted:
Sep 20, 2005
Last Update Posted:
Sep 7, 2016
Last Verified:
Sep 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms: