A phase III, multicentric, multinational, controlled, randomised, open study comparing the immunogenicity, reactogenicity and safety of Henogen’s new adjuvanted hepatitis B vaccine, HB-AS02V, administered according to 0, 1, 6 months schedule to that of GlaxoSmithKline Biologicals’ adjuvanted hepatitis B vaccine, Fendrix®, administered according to 0, 1, 2, 6 months schedule, in hepatitis B naïve pre-dialysis, peritoneal dialysis and haemodialysis patients (above or equal to 15 years of age). - HN014/HBV-001
- Conditions
- hepatitis B naïve pre-dialysis, peritoneal dialysis and haemodialysis patients from 15 years of age
- Registration Number
- EUCTR2005-004053-10-BE
- Lead Sponsor
- Henogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 300
A male or female subject above or equal to 15 years of age at the time of the first vaccination.
Seronegative for anti-HBs antibodies, anti-HBc antibodies and for HBsAg at screening.
Pre-dialysis patients, peritoneal dialysis patients or haemodialysis patients. Pre-dialysis patient is defined as a patient with a documented creatinine clearance of less or equal to 30ml/min as estimated by the Cockroft-Gault formula.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Use of any registered vaccine within 7 days before the first dose of study vaccine.
Previous vaccination against hepatitis B (whether or not the subject responded to the vaccine).
History of hepatitis B infection.
Known exposure to hepatitis B virus within 6 months.
Use of immunoglobulins within six months preceding the first study vaccination.
Immunosuppression caused by the administration of parenteral steroids or chemotherapy (oral steroids are allowed).
Any confirmed or suspected human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
Pregnant or lactating female
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method