hepatitis B naïve pre-dialysis, peritoneal dialysis and haemodialysis patients from 15 years of age
Conditions
Interventions
Product Name: new adjuvanted HBsAg vaccine
Product Code: HB-AS02V
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: HBsAg
Other descriptive nam
Sponsors
Henogen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superiority of HB-AS02V vaccine compared to Fendrix® vaccine in terms of anti-HBs seroprotection rates (percentage of subjects with anti-HBs antibody concentrations above or equal to 10 mIU/ml) at Month 2.;Secondary Objective: To explore the superiority of HB-AS02V vaccine (at Month 2) compared to Fendrix® vaccine (at Month 3) in terms of anti-HBs seroprotection rates and in terms of anti-HBs geometric mean concentrations (GMC). To explore the superiority of HB-AS02V compared to Fendrix® vaccine in terms of anti-HBs seroprotection rates at Months 1, 3, 6 and 7 and in terms of anti-HBs GMC achieved. To describe the immunogenicity of HB-AS02V and Fendrix® vaccines in terms of anti-HBs seropositivity rate, seroprotection rates, the percentage of subjects with anti-HBs antibody concentrations above or equal to 100 mIU/ml and GMCs at Months 1, 2, 3, 6 and 7. To evaluate the quality of the immune response elicited one month after a full course of primary vaccination in a subset of subjects using a competitive RF1 ELISA. To evaluate the safety and reactogenicity of the HB-AS02V vaccine and of Fendrix® vaccine after each dose and per subject.;Primary end point(s): Observed variable : Anti-HBs antibody concentrations at Month 2 Derived variable : Anti-HBs seroprotection (SP) rate at Month 2. | — |
Countries
Czech Republic, Hungary
Outcome results
None listed