CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 359 enrolled
Drug / intervention
EngerixB, GlaxoSmithKline Vaccinesbiological
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/NCT02169674
NCT02169674Phase 4Completed

Sustaining Protection Against Hepatitis B From Infancy to Adulthood: Assessing the Case for a Booster Dose in Adolescence

University of British Columbia·interventional·Posted Jun 23, 2014·Updated Mar 21, 2019

In Brief

A Phase 4 clinical trial evaluating EngerixB, GlaxoSmithKline Vaccines for Hepatitis B. Completed, enrolled 359 participants across 1 site.

Detailed Summary

This study looks at protection in 10-11 and 15-16 year olds, immunized as infants with Hepatitis B (HB) vaccine to see if they still have residual protection against Hepatitis B disease. Adolescents will be invited to have a blood test and those without a minimal level of protection (antibody titer) will be offered a "test" vaccination to see if they still have capacity to recall an immune response. About one month later they will get another blood test to see if a booster response occurred. A few participants will have lost protection (no booster response) and will be offered a second HB vaccination to restore protection. Results of this study could influence the way in which children in British Columbia (BC) are immunized against HB disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesCanada

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 23, 2014
Enrollment StartSep 1, 2014
Primary CompletionAug 1, 2015
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 12.0 years ago

Interventions

EngerixB, GlaxoSmithKline Vaccinesbiological