Status:
COMPLETED
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)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Hepatitis B
Eligibility:
All Genders
16-20 years
Phase:
PHASE4
Brief Summary
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, ...
Detailed Description
The primary study was to evaluate the immunogenicity and protective efficacy of hepatitis B vaccine administered according to a 0, 1, 2, 12 month schedule in newborns of anti-hepatitis B envelope anti...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects who had participated in the primary study.
- Written informed consent obtained from the subject.
Exclusion
Key Trial Info
Start Date :
October 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00240539
Start Date
October 1 2003
End Date
July 1 2008
Last Update
December 8 2016
Active Locations (1)
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1
GSK Investigational Site
Bangkok, Thailand, 10330