Phase 4
N=73
LT F-up Study 16-20 Yrs After Vaccine Dose of Hepatitis B With/Without HBIg in Newborns to HBeAg+ Mothers
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00240526 ↗Enrolled (actual)
73
Serious AEs
—
Results posted
Jul 2010
Primary outcome: Primary: Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). — 118.6; 14.8; 142.8; 24.2 mIU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Engerix™ -B (Biological); Hepatitis B immunoglobulin (HBIg) (Biological)
- Age
- Pediatric, Adult · 16+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by Enzyme-Linked Immunosorbent Assay (ELISA). |
118.6; 14.8; 142.8; 24.2; 119.3; 14.1 | — |
| PRIMARY Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration as Measured by ChemiLuminescence ImmunoAssay (CLIA). |
60.1; 5.8; 159.0; 11.7; 44.0; 5.1 | — |
| PRIMARY Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values Enzyme-Linked Immunosorbent Assay (ELISA). |
17; 7; 10; 11; 16; 4 | — |
| PRIMARY Adjusted Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations Above Pre-defined Cut-off Values as Measured by ChemiLuminescence ImmunoAssay (CLIA) |
13.0; 4.2; 6.0; 7.0; 12.0; 3.9 | — |
| PRIMARY Number of Subjects With Positive Results for Serological Markers for Hepatitis B Infection |
0; 1; 0; 3; 4; 7 | — |
| PRIMARY Number of Subjects With Different Hepatitis B Infection Statuses |
0; 0; 0; 4; 5; 5 | — |
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 comply with the FDA Amendment Act, Sep 2007.
No additional subjects will be recruited during this long-term follow-up study and no vaccine will be administered.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- None
Data sourced from ClinicalTrials.gov (NCT00240526). 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.