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, to that of Aventis Pasteur MSD’s hepatitis B vaccine, HBVAXPRO®, administered according to a 0, 1 months schedule, in pre-dialysis, peritoneal dialysis and haemodialysis patients (above or equal to 15 years of age), who did not respond to previous hepatitis B vaccination. NOTE: Age at enrolment will be above or equal to 18 years for subjects in Poland. - HN017/HBV-003
- Conditions
- pre-dialysis, peritoneal dialysis and haemodialysis patients (above or equal to 18 years of age), who did not respond to previous hepatitis B vaccination.MedDRA version: 9.1Level: SOCClassification code 10042613Term: Surgical and medical proceduresMedDRA version: 9.1Level: HLGTClassification code 10025309Term: Haematological and lymphoid tissue therapeutic proceduresMedDRA version: 9.1Level: HLTClassification code 10052724Term: Haematological therapeutic procedures NECMedDRA version: 9.1Level: PTClassification code 10061105Term: DialysisMedDRA version: 9.1Level: LLTClassification code 10061105Term: DialysisMedDRA version: 9.1Level: SOCClassification code 10038359Term: Renal and urinary disordersMedDRA version: 9.1Level: HLGTClassification code 10038430Term: Renal disorders (excl nephropathies)MedDRA version: 9.1Level: HLTClassification code 10038443Term: Renal failure and impairmentMedDRA version: 9.1Level: PTClassification code 10038444Term: Renal failure chronic
- Registration Number
- EUCTR2005-004058-28-PL
- Lead Sponsor
- Henogen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 300
A male or female subject above or equal to 18 years of age at the time of the first vaccination.
Seronegative for anti-HBc antibodies and HBsAg at screening.
Pre-dialysis, peritoneal dialysis or haemodialysis patients. Pre-dialysis patient is defined as a patient with a documented creatinine clearance of less than or equal to 30 ml/min as estimated by the Cockroft-Gault formula.
Documented evidence of previous hepatitis B vaccination with at least one full primary vaccination course of minimum four injections of licensed vaccine. The last dose should have been administered at least two months before the planned first dose of study vaccine in this study.
Documented evidence of non-response to previous hepatitis B vaccination (non-response defined as anti-HBs antibody < 10mIU/ml) after at least one to maximum three months after the full course of licensed vaccine / or the last booster dose
Are the trial subjects under 18? no
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
Subjects who have been included in the HN014/HBV-001 study.
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 preceding the first dose of study vaccine.
History of hepatitis B infection or known exposure to hepatitis B virus within 6 months at the exception of the dialysis procedure.
Use of immunoglobulins within six months preceding the first dose of study vaccine.
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