Phase 4 N=109 Prevention

Follow-up Study 16-20 Years After Primary Vaccination Against Hepatitis B of Newborns From HBeAg+ & HBsAg+ Mothers

Hepatitis B

Bottom Line

View on ClinicalTrials.gov: NCT00240500 ↗

Enrolled (actual)

109

Serious AEs

—

Results posted

May 2009

Primary outcome: Primary: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations — 87.6; 43.8; 143.4; 34.4 mIU/mL

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Engerix™-B (Biological)
Age: Pediatric, Adult · 16+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Nov 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	—

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.

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

View full record on ClinicalTrials.gov →

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.