Hepatitis B Clinical Trial
Official title:
Long-term Follow-Up Studies at Years 16-20, to Evaluate the Persistence of Immune Response of GSK Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers in Comparison With a Historical Control Group
Verified date | December 2009 |
Source | GlaxoSmithKline |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ministry of Public Health |
Study type | Interventional |
This study is performed to evaluate the persistence of anti-hepatitis B surface antigen
(HBs) antibodies up to 16, 17, 18, 19 and 20 years after administration of the first dose of
the study vaccine, Engerix-B™. No new subjects will be recruited in this long-term follow-up
study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Status | Completed |
Enrollment | 36 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 16 Years to 20 Years |
Eligibility |
Inclusion Criteria: - Subjects who had participated in the primary study. - Written informed consent obtained from the subject. |
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 | Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies | At Years 16, 17, 18, 19 and 20 after primary vaccination | No | |
Primary | Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus | At Years 16, 17, 18,19 and 20 after primary vaccination | No | |
Primary | Number of Subjects With Chronic and With Clinical HBV Infection | From year 16 through to year 20 | No |
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