Trials / Completed
CompletedNCT00519649
Long-term Persistence of Immunity Against Hepatitis B in 7-8 Years Old Children After Hepatitis B Vaccination.
An Open, Phase IV, Single-group, Multicentre Study to Assess the Long-term Persistence of Antibodies Against Hepatitis B and the Immune Response to a Hepatitis B (HBV) Vaccine Challenge in Children Aged 7-8 Years of Age and Previously Vaccinated in Infancy With GSK Biologicals' HBV Vaccine (Engerix™-B).
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 301 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 7 Years – 8 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to assess the persistence of immunity to hepatitis B in children who received three consecutive doses of HBV vaccine (EngerixTM-B) in infancy. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Engerix™-B Kinder | Intramuscular injection, 1 dose |
Timeline
- Start date
- 2007-08-31
- Primary completion
- 2007-12-31
- Completion
- 2007-12-31
- First posted
- 2007-08-22
- Last updated
- 2018-08-17
- Results posted
- 2009-05-27
Locations
35 sites across 1 country: Germany
Source: ClinicalTrials.gov record NCT00519649. Inclusion in this directory is not an endorsement.