E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
hepatitis B pre-dialysis, peritoneal dialysis and haemodialysis patient from 15 year of age |
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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 evaluate persistence of anti-HBs antibodies at Months 12, 24 and 36, elicited by primary vaccination with HB-AS02V vaccine in comparison to that elicited by primary vaccination with Fendrix vaccine. |
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E.2.2 | Secondary objectives of the trial |
·To evaluate the quality of the immune response elicited at Months 12, 24 and 36 in a subset of subjects using a competitive RF1 ELISA.
·To describe serious adverse events (SAE) reported retrospectively at each of the long-term time points (i.e Months 12, 24 and 36). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
·Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol (e.g., return for follow-up visits) should be enrolled in the study.
·Written informed consent obtained from the subject/ from the parent/ guardian of the subject at the first long-term time point that the subject comes back to participate in this study.
·Subjects who completed the full course of primary vaccination (three doses of HBV-AS02V vaccine or four doses of Fendrix vaccine) in the study 105757 (HN014/HBV-001) and return at any of the long-term time points (i.e. 12, 24 or 36 months) after the first dose of the primary vaccination.
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E.4 | Principal exclusion criteria |
·Immunosuppression caused by the administration of parenteral steroids or chemotherapy.
·Any confirmed or suspected human immunodeficiency virus (HIV) infection.
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E.5 End points |
E.5.1 | Primary end point(s) |
Observed variable · Anti-HBs antibody concentrations at Months 12, 24 and 36. Derived variable · Anti-HBs seroprotection rate (percentage of subjects with anti-HBs antibody concentrations ³ 10 mIU/ml) at Months 12, 24 and 36.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
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 | 13 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 23 |
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
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |