At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 303 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.
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
In Brief
A Phase 4 clinical trial evaluating Engerix™-B Kinder for Hepatitis B. Completed, enrolled 303 participants across 10 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesGermany
Collaborators--
Timeline
Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartJul 2013
Primary CompletionFeb 2014
TodayJul 2026
First PostedMay 6, 2013
Enrollment StartJul 19, 2013
Primary CompletionFeb 21, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 13.2 years ago
Interventions
Engerix™-B Kinderbiological
Single dose administered intramuscularly in the deltoid region of non-dominant arm at Day 0.