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.
Persistence of Hepatitis B Antibodies, Immunogenicity and Safety of GSK Biologicals' Hepatitis B Vaccine Engerix™-B Kinder (SKF103860) Challenge Dose in Adolescents Vaccinated With Four Doses of Infanrix™ Hexa (SB217744) During Infancy
In Brief
A Phase 4 clinical trial evaluating Engerix™-B Kinder for Hepatitis B. Completed, enrolled 301 participants across 11 sites.
Detailed Summary
The purpose of this study is to assess the long-term persistence of immunity to hepatitis B in adolescents aged 12-13 years who were vaccinated with four doses of Infanrix™-Hexa in infancy and to assess the anamnestic response, immunogenicity, safety and reactogenicity of a single challenge dose of the hepatitis B vaccine Engerix™-B Kinder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesGermany
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartFeb 2014
Primary CompletionSep 2014
TodayJul 2026
First PostedFeb 3, 2014
Enrollment StartFeb 18, 2014
Primary CompletionSep 23, 2014
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 12.4 years ago
Interventions
Engerix™-B Kinderbiological
Single dose administered intramuscularly in deltoid region of non-dominant arm.