CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A. +2 morebiological
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/NCT01777295
NCT01777295Phase 2Completed
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Development of Read-outs to Detect and Characterise the Early and Adaptive Immune Responses in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen in Combination With a GSK Biologicals' Adjuvant System

GlaxoSmithKline·interventional·Posted Jan 28, 2013·Updated Jan 4, 2019

In Brief

A Phase 2 clinical trial evaluating Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A., EngerixTM-B, and 1 other intervention for Hepatitis B. Completed, enrolled 81 participants across 1 site.

Detailed Summary

This study aims to develop innovative immunological read-outs and new technologies in order to further characterise the early immune response and its kinetics as well as the adaptive immune responses to adjuvanted vaccines. This study will also evaluate the reactogenicity in healthy, hepatitis B virus naive adults vaccinated with the hepatitis B surface antigen in combination with a GSK Biologicals' Adjuvant System.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B
CountriesBelgium
CollaboratorsRegion of Wallonia, Public Private Partnership with Institute for Medical Immunology (Universite Libre de Bruxelles)

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJan 28, 2013
Enrollment StartFeb 25, 2013
Primary CompletionMay 17, 2016
Study CompletionSep 13, 2016
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.4 years ago

Interventions

Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.biological

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

EngerixTM-Bbiological

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.

Placebobiological

Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.