Last updated: 11/06/2018 23:21:56
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Long-Term Follow Up Study at Years 16-20, to Evaluate the Persistence of Immune Response of GlaxoSmithKline Biologicals' Hepatitis B Vaccine in Newborns of HBeAg+ and HBsAg+ Mothers
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations
Timeframe: Years 17, 18, 19 and 20.
Prevalence of serological markers for hepatitis B infection
Timeframe: Years 17, 18, 19 and 20.
Clinical review for hepatitis B infection status
Timeframe: Over the entire 4 year follow up period (17 - 20 years)
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Engerix™-B
Enrollment:
109
Observational study model:
Not applicable
Primary completion date:
2007-09-11
Time perspective:
Not applicable
Clinical publications:
Poovorawan Y et al. (2009) Long-term benefit of hepatitis B vaccination among children in Thailand with transient hepatitis B virus infection who were born to hepatitis B surface antigen–positive mothers. J Infect Dis. 200(1): 33-38.
Poovorawan Y et al. (2010) Persistence of antibodies and immune memory to hepatitis B vaccine 20 years after infant vaccination in Thailand. Vaccine. 28(3): 730-736.
Poovorawan Y et al. (2011) Evidence of protection against clinical disease and chronic hepatitis B infection 20 years after infant hepatitis B vaccination in a high endemicity region. J Viral Hepat. 18(5):369-375.
Medical condition
Hepatitis B
Product
SKF103860
Collaborators
Not applicable
Study date(s)
October 2003 to November 2007
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
16 - 20 years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- Subjects who had received at least one dose of the study vaccine in the primary study (103860/064)
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2007-09-11
Actual study completion date
2007-09-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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