CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 49 enrolled
Drug / intervention
EngerixTM-Bbiological
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/NCT00774995
NCT00774995Phase 4Completed
CompareCT.gov

Study to Evaluate the Immune Response of Healthy Subjects Who Received Neonatal Vaccination Course With GSK Biologicals' Engerix™-B Vaccine, Approximately 20 Years Ago.

GlaxoSmithKline·interventional·Posted Oct 17, 2008·Updated Nov 2, 2016

In Brief

A Phase 4 clinical trial evaluating EngerixTM-B for Hepatitis B. Completed, enrolled 49 participants across 1 site.

Detailed Summary

This study will evaluate the immune response of healthy subjects who received neonatal vaccination course with GSK Biologicals' Engerix™-B vaccine, approximately 20 years ago. The presence of immune memory against hepatitis B surface antigen (HBsAg) in these subjects will be investigated by the administration of a challenge dose of hepatitis B vaccine and the comparison of their antibody concentration before and one month after vaccination. This protocol posting deals with objectives \& outcome measures of the booster phase. No new subjects will be recruited during this booster phase of the study.

Study Details

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

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 17, 2008
Enrollment StartNov 1, 2008
Primary CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.7 years ago

Interventions

EngerixTM-Bbiological

Intramuscular injection, one dose.