At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 301 enrolled
Drug / intervention
Engerix™-B Kinderbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 4 clinical trial evaluating Engerix™-B Kinder for Hepatitis B Vaccine. Completed, enrolled 301 participants across 35 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Vaccine
CountriesGermany
Collaborators--
Timeline
Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 2007
Enrollment StartAug 2007
Primary CompletionDec 2007
TodayJul 2026
First PostedAug 22, 2007
Enrollment StartAug 31, 2007
Primary CompletionDec 31, 2007
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 18.9 years ago
Interventions
Engerix™-B Kinderbiological
Intramuscular injection, 1 dose