At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 300 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 Antibody Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine (Engerix-B Kinder) Challenge in Children Previously Vaccinated With Infanrix Hexa Vaccine
In Brief
A Phase 4 clinical trial evaluating Engerix-B™ Kinder for Hepatitis B. Completed, enrolled 300 participants across 12 sites.
Detailed Summary
This study will evaluate the persistence of immunity to hepatitis B in healthy children aged 7 to 8 years, after previous vaccination with Infanrix hexa™ in the first two years of life, and also their ability to mount an immune response to the challenge dose of Engerix-B™ Kinder.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesGermany
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2011
Enrollment StartApr 2011
Primary CompletionSep 2011
TodayJul 2026
First PostedApr 12, 2011
Enrollment StartApr 26, 2011
Primary CompletionSep 28, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 15.2 years ago
Interventions
Engerix-B™ Kinderbiological
Intramuscular, single dose