Last updated: 11/06/2018 23:22:31
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Comparative study of the immunogenicity and protective efficacy of GlaxoSmithKline Biologicals’ rec-DNA hepatitis B vaccine with or without hepatitis B immunoglobulins (HBIg) in newborns of HBeAg+ mothers.
Trial description: To evaluate the persistence of anti-HBs antibodies up to 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.No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as measured by Enzyme-Linked Immunosorbent Assay (ELISA).
Timeframe: At Years 15, 16, 17, 18, 19 and 20
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as measured by ChemiLuminescence ImmunoAssay (CLIA).
Timeframe: At Years 19 and 20
Number of Subjects With Anti-hepatitis B surface antigen (anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA).
Timeframe: At Years 15, 16, 17, 18, 19 and 20
Adjusted number of Subjects With Anti-hepatitis B surface antigen (anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as measured by ChemiLuminescence ImmunoAssay (CLIA)
Timeframe: At Years 19 and 20
Number of subjects with positive results for serological markers for hepatitis B infection
Timeframe: At Years 15, 16, 17, 18, 19 and 20
Number of subjects with different hepatitis B infection statuses
Timeframe: Over the entire follow up period (Final assessment of clinical significance was analyzed after the Year 20 time point)
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: Engerix™ -B
Biological/vaccine: Hepatitis B immunoglobulin (HBIg)
Enrollment:
79
Observational study model:
Not applicable
Primary completion date:
2010-18-03
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. JID. 200 (1) 33-38.
Medical condition
Hepatitis B
Product
SKF103860
Collaborators
Not applicable
Study date(s)
October 2003 to March 2010
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
16 - 20 years
Accepts healthy volunteers
Yes
- Subjects who had received at least one dose of the study vaccine in the primary study
- Written informed consent obtained from each subject before each blood sampling visit
- None
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who had received at least one dose of the study vaccine in the primary study
- Written informed consent obtained from each subject before each blood sampling visit
Exclusion criteria:
- None
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
2010-18-03
Actual study completion date
2010-18-03
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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