E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
pre-dialysis, peritoneal dialysis and haemodialysis patients (above or equal to 18 years of age), who did not respond to previous hepatitis B vaccination. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10042613 |
E.1.2 | Term | Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10025309 |
E.1.2 | Term | Haematological and lymphoid tissue therapeutic procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10052724 |
E.1.2 | Term | Haematological therapeutic procedures NEC |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061105 |
E.1.2 | Term | Dialysis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10061105 |
E.1.2 | Term | Dialysis |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038359 |
E.1.2 | Term | Renal and urinary disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10038430 |
E.1.2 | Term | Renal disorders (excl nephropathies) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10038443 |
E.1.2 | Term | Renal failure and impairment |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10038444 |
E.1.2 | Term | Renal failure chronic |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038444 |
E.1.2 | Term | Renal failure chronic |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the superiority of HB-AS02V compared to HBVAXPRO® (40 µg) in terms of seroprotection rates (defined as percentage of subjects with anti-HBs antibody concentrations above or equal to 10 mIU/ml) achieved at Month 2. |
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E.2.2 | Secondary objectives of the trial |
To explore the superiority of HB-AS02V vaccine compared to HBVAXPRO® (40 µg) vaccine in terms of seroprotection rates achieved at Month 1.
To describe the immunogenicity of HB-AS02V and HBVAXPRO® (40 µg) vaccines at all time points, in terms of anti-HBs seropositivity rate (defined as percentage of subjects with anti-HBs antibody concentrations above or equal to 3.3 mIU/ml), seroprotection rates, percentage of subjects with anti-HBs concentrations above or equal to 100 mIU/ml and GMCs.
To evaluate the safety and reactogenicity of the HB-AS02V and HBVAXPRO® (40 µg) vaccines after each dose and per subject.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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
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E.4 | Principal exclusion criteria |
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
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E.5 End points |
E.5.1 | Primary end point(s) |
Observed variable : Anti-HBs antibody concentrations at Month 2. Derived variable : Anti-HBs seroprotection (SP) rate at Month 2.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 29 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |