NCT01777295View on ClinicalTrials.gov

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

PHASE2CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

February 25, 2013

Primary Completion Date

May 17, 2016

Study Completion Date

September 13, 2016

Conditions
Hepatitis B
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.

Trial Locations (1)

2060

GSK Investigational Site, Antwerp

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
collaborator

Region of Wallonia

UNKNOWN

collaborator

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

UNKNOWN

lead

GlaxoSmithKline

INDUSTRY

NCT01777295 - 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 | Biotech Hunter | Biotech Hunter