Trials / Completed
CompletedNCT01847430
Evaluation of the Long-term Persistence of Immunity to Hepatitis B, in Adolescents Vaccinated in Infancy With Engerix™-B Kinder
Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Challenge Dose of GSK Biologicals' Hepatitis B Virus Vaccine, Engerix™-B Kinder (SKF103860), in 15-16 Years Old Adolescents, Vaccinated in Infancy With Engerix™-B Kinder
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 303 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 15 Years – 16 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 15-16 years who were vaccinated with Engerix™-B Kinder in infancy. The study will also assess the immune response to a challenge dose of Engerix™-B Kinder in these subjects.
Detailed description
This MDD has been updated following the Protocol Amendment 1, dated 20 June 2013. The Protocol was amended because GSK replaced its in-house Enzyme-Linked ImmunoSorbent Assay (ELISA) that was used to measure anti-HBs (antibodies to Hepatitis B surface antigen) antibody concentrations with ChemiLuminescence ImmunoAssay (CLIA). Additionally, the threshold level of prednisone was modified to reflect the dosage normally prescribed to adolescents.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Engerix™-B Kinder | Single dose administered intramuscularly in the deltoid region of non-dominant arm at Day 0. |
Timeline
- Start date
- 2013-07-19
- Primary completion
- 2014-02-21
- Completion
- 2014-02-21
- First posted
- 2013-05-06
- Last updated
- 2018-08-20
- Results posted
- 2016-03-02
Locations
10 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT01847430. Inclusion in this directory is not an endorsement.