Hepatitis B Clinical Trial
Official title:
Long-Term F-U Study at Yrs 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers
Verified date | May 2009 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ministry of Public Health |
Study type | Interventional |
The purpose of this study is to evaluate the persistence of anti-hepatitis B surface antigen (anti-HBs) antibodies 16, 17, 18, 19 and 20 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.
Status | Completed |
Enrollment | 109 |
Est. completion date | November 2007 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years to 20 Years |
Eligibility |
Inclusion Criteria: - Subjects who had received at least one dose of the study vaccine in the primary study (103860/064) - Written informed consent obtained from each subject before each blood sampling visit |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Thailand | GSK Investigational Site | Bangkok |
Lead Sponsor | Collaborator |
---|---|
GlaxoSmithKline |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Anti-Hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations | Years 17, 18, 19 and 20. | No | |
Primary | Prevalence of Serological Markers for Hepatitis B Infection | Years 17, 18, 19 and 20. | No | |
Primary | Clinical Review for Hepatitis B Infection Status | Over the entire 4 year follow up period (17 - 20 years) | No |
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