Status:
COMPLETED
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
16-20 years
Phase:
PHASE4
Brief Summary
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 comp...
Detailed Description
The primary study was to evaluate the reactogenicity, immunogenicity and protective efficacy of a hepatitis B vaccine in healthy neonates of HBeAg positive mothers if administered with or without a do...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00240526
Start Date
October 1 2003
End Date
March 1 2010
Last Update
December 7 2016
Active Locations (1)
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1
GSK Investigational Site
Bangkok, Thailand, 10330