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Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System

NCT01777295 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-01-04

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

EngerixTM-B

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

BIOLOGICAL

Placebo

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

Sponsors & Collaborators

  • Region of Wallonia

    collaborator UNKNOWN

  • Public Private Partnership with Institute for Medical Immunology (Universite Libre de Bruxelles)

    collaborator UNKNOWN

  • GlaxoSmithKline

    lead INDUSTRY

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-02-25
Primary Completion
2016-05-17
Completion
2016-09-13

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01777295 on ClinicalTrials.gov