CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 306 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.

Search/NCT00984139
NCT00984139Phase 4Completed
CompareCT.gov

Long-term Persistence of Hepatitis B Antibodies and Immune Response to a Hepatitis B Vaccine Challenge in 12-13 Year Old Adolescents, Vaccinated in Infancy With GlaxoSmithKline (GSK) Biologicals' HBV Vaccine (Engerix™-B)

GlaxoSmithKline·interventional·Posted Sep 25, 2009·Updated Aug 20, 2018

In Brief

A Phase 4 clinical trial evaluating Engerix™-B Kinder for Hepatitis B. Completed, enrolled 306 participants across 24 sites.

Detailed Summary

This phase IV open study will evaluate the persistence of humoral antibodies against hepatitis B as well as the immune response to a challenge dose of hepatitis B vaccine in adolescents aged 12-13 years, who received three consecutive doses of GSK Biologicals' recombinant hepatitis B vaccine (Engerix™-B) in infancy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesGermany
Collaborators--

Timeline

Phase 4CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 25, 2009
Enrollment StartOct 12, 2009
Primary CompletionApr 7, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 16.8 years ago

Interventions

Engerix™-B Kinderbiological

Intramuscular, one dose.