Phase 4
Completed N=109
Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers
Source: ClinicalTrials.gov NCT00240500 ↗Enrolled (actual)
109
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations — 87.6; 43.8; 143.4; 34.4 mIU/mL
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 vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations |
87.6; 43.8; 143.4; 34.4; 90.9; 10.6 | — |
| PRIMARY Prevalence of Serological Markers for Hepatitis B Infection |
100; 93.7; 100; 100; 96.3; 100 | — |
| PRIMARY Clinical Review for Hepatitis B Infection Status |
0; 1; 1; 0; 0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00240500). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.