Last updated: 11/02/2018 23:05:15
Long Term Follow-Up Study 16-20 Years After Hepatitis B Vaccination in Newborns of Mothers Who Were Seropositive for hepatitis B envelope antigen (HBeAg) & hepatitis B surface antigen (HBsAg)
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Number of subjects seropositive for anti-hepatitis B surface antigen (anti-HBs) antibodies
Timeframe: At Years 16, 17, 18, 19 and 20 after primary vaccination
Number of subjects who tested positive for markers of infection with hepatitis B virus
Timeframe: At Years 16, 17, 18,19 and 20 after primary vaccination
Number of subjects with chronic and with clinical HBV infection
Timeframe: From year 16 through to year 20
Secondary outcomes:
Not applicable
Interventions:
Procedure/surgery: Blood sampling
Enrollment:
36
Observational study model:
Not applicable
Primary completion date:
2008-25-07
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.
Poovorawan Y et al. Persistence of anti-HBs antibodies and immune memory 20-years after hepatitis B vaccination among children in Thailand. Abstract presented at the 9th International Congress of Tropical Pediatrics (ICTP). Bangkok, Thailand. 18-20 October 2011.
Medical condition
Hepatitis B
Product
SKF103860
Collaborators
Not applicable
Study date(s)
October 2003 to July 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
16 - 20 years
Accepts healthy volunteers
Yes
- Inclusion Criteria:
- Subjects who had participated in the primary study.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who had participated in the primary study.
- Written informed consent obtained from the subject.
Inclusion Criteria:
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
2008-25-07
Actual study completion date
2008-25-07
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.
Additional information about the trial
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