E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Female and male pre-dialysis, peritoneal dialysis and haemodialysis subjects with documented seroprotection (anti- HBs antibody concentrations ≥ 10 mIU/ml) following previous hepatitis B vaccination (one full course of four injections of licensed vaccine, without any subsequent booster) but for whom antibody concentrations dropped below the seroprotection level. |
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MedDRA Classification |
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 superiority of HB-AS02V compared to HBVAXPRO® in terms of GMCs achieved at Month 1. |
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E.2.2 | Secondary objectives of the trial |
• To describe the immunogenicity of HB-AS02V and HBVAXPRO® in terms anti-HBs seropositivity rate (defined as percentage of subjects with anti-HBs antibody concentrations ≥ 3.3 mIU/ml), seroprotection rate (defined as percentage of subjects with anti-HBs antibody concentrations ≥ 10 mIU/ml) and percentage of subjects with anti-HBs antibody concentrations ≥ 100 mIU/ml, at Month 1. • To evaluate the safety and reactogenicity of the HBAS02V vaccine and of HBVAXPRO® after one injection. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Subjects whom the investigator believes that they can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study. • A male or female subject ≥ 15 years of age at the time of the study entry. • Written informed consent obtained from the subject/ subject’s parents or guardians. • Pre-dialysis patients, peritoneal dialysis patients and patients on haemodialysis. Predialysis patients is defined as a subject with a documented creatinine clearance of ≤ 30 ml/min. (as estimated by the Cockroft-Gault formula). • Seronegative for anti-HBc antibodies and for HBsAg at screening. • Documented previous hepatitis B vaccination with one full primary course of four injections of licensed vaccine, without any administration of subsequent booster. The last dose should have been administered at least two months before the planned dose of study vaccine in this study. • Documented response to previous hepatitis B vaccination (anti-HBs ≥ 10 mIU/ml after one full course of four injections of licensed vaccine, without subsequent boosters) but for whom there is a documented loss of anti-HBs antibody concentrations below 10 mIU/ml. • If the subject is female, she must be of non-childbearing potential, i.e., either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used medically-approved contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. |
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E.4 | Principal exclusion criteria |
who have participated in the HN014/HBV-001 study. • Use of any investigational or non-registered drug or vaccine within 30 days preceding the study vaccine administration, or planned use during the study period. • Use of any registered vaccine within 7 days preceding the study vaccine administration. • History of hepatitis B infection. • Known exposure to hepatitis B virus within six 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. • Acute disease at the time of enrolment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral/ axillary temperature < 37.5°C (or 37 °C in Czech Republic). • Oral/axillary temperature ≥ 37.5 °C (or 37 °C in Czech Republic). • 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 1. Derived variable • Anti-HBs geometric mean concentrations (GMCs) (calculated on all subjects) at Month 1. |
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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 | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | No |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 2 |