Status:
COMPLETED
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
16-20 years
Phase:
PHASE4
Brief Summary
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 vacci...
Detailed Description
The primary study was designed to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine in newborns of HBeAg+ and HBsAg+ mothers in comparison with a historical control group. Th...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00240500
Start Date
October 1 2003
End Date
November 1 2007
Last Update
December 21 2016
Active Locations (1)
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1
GSK Investigational Site
Bangkok, Thailand, 10330