E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prophylactic vaccination against infection with hepatitis B virus in renal predialysis and dialysis patients |
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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 | LLT |
E.1.2 | Classification code | 10038474 |
E.1.2 | Term | Renal insufficiency |
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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 |
Among dialysis patients and predialysis patients who receive 3 doses of either modified process hepatitis B vaccine or ENGERIX-B, to describe (1 month after the third dose of vaccine) the seroprotection rate (SPR) for the modified process hepatitis B vaccine and ENGERIX-B. |
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E.2.2 | Secondary objectives of the trial |
- Among dialysis patients and predialysis patients who receive 4 doses of either modified process hepatitis B vaccine or ENGERIX-B, to describe (1 month after the fourth dose of the vaccine) the SPR for the modified process hepatitis B vaccine and ENGERIX-B. - To describe the safety and tolerability of the modified process hepatitis B vaccine in dialysis and predialysis patients. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Male and female predialysis patients (defined as having a creatinine clearance <=30 mL/min as calculated according to the Cockroft-Gault formula) or patients currently receiving either hemodialysis or peritoneal dialysis. 2. Visit 1 (screening visit) blood sample with laboratory confirmed negative result for HBsAg, anti-HBc and anti-HBs. 3. At least 18 years of age. 4. For women, a negative urine pregnancy test just prior to vaccination on visit 2 (day 1) |
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E.4 | Principal exclusion criteria |
1. History of previous hepatitis B infection. 2. History of vaccination with any hepatitis B vaccine either alone or in combination. 3. Recent (<72 hours) history of febrile illness (oral temperature >=37.8ᄎC/>=100.0ᄎF). 4. Known or suspected hypersensitivity to any component of RECOMBIVAX HB or ENGERIX-B (e.g., aluminum, yeast). 5. Recent administration (within 3 months prior to first injection with the study vaccine)of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood derived product or plans to receive such products within the study period. 6. Receipt of licensed inactivated vaccines within 14 days prior to vaccination with the study vaccine. Receipt of licensed live virus vaccines within the 30 days prior to vaccination with the study vaccine or plans to receive licensed vaccines within 30 days following each dose of study vaccine. 7. Receipt of investigational drugs or other investigational vaccines within 3 months prior to first injection with the study vaccine or plans to receive investigational drugs or vaccines within the study period. 8. Known or suspected impairment of immunologic function (other than from renal disease) (e.g., HIV positivity, end-stage liver disease). 9. Recent use (within 3 months prior to first injection with the study vaccine) of systemic immunomodulatory medications (e.g., systemic corticosteroids). Does not include topical and inhaled steroids. 10. Pregnant women, nursing mothers, and women planning to become pregnant within the study period. 11. Currently abusing IV drugs. 12. Any condition that, in the opinion of the investigator, might interfere with the evaluation of the study objectives. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary purpose of this study is to estimate the SPR (percent of patients with an anti-HBs titer >= 10 mIU/mL) at 1 month after the third and fourth doses for the modified process hepatitis B vaccine and ENGERIX B |
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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 | 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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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.8.5 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 7 |
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 | 7 |