Phase 4
N=36
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)
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00240539 ↗Enrolled (actual)
36
Serious AEs
—
Results posted
Nov 2009
Primary outcome: Primary: Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies — 0; 22; 2; 21 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Blood sampling (Procedure)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Seropositive for Anti-hepatitis B Surface Antigen (Anti-HBs) Antibodies |
0; 22; 2; 21; 1; 20 | — |
| PRIMARY Number of Subjects Who Tested Positive for Markers of Infection With Hepatitis B Virus |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Subjects With Chronic and With Clinical HBV Infection |
0; 0; 1; 0; 0; 0 | — |
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, Engerix-B™. No new subjects will be recruited in this long-term follow-up study.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Eligibility Criteria
Inclusion Criteria
- Subjects who had participated in the primary study.
- Written informed consent obtained from the subject.
Data sourced from ClinicalTrials.gov (NCT00240539). 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.