E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
No medical condition, healthy subjects |
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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 the lot-to-lot consistency of three manufacturing lots of HB-AS02V, in terms of anti-HBs seroprotection rates (anti-HBs antibody concentrations ³ 10 mIU/ml) at Month 2 . |
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E.2.2 | Secondary objectives of the trial |
-· To evaluate the lot-to-lot consistency of HB-AS02V, in terms of anti-HBs antibody GMC at Month 2. -· To evaluate the immunogenicity of HB-AS02V, in terms of seropositivity rates (percentage of subjects with anti-HBs antibody concentrations ³ 3.3 mIU/ml), seroprotection rates, GMCs and percentage of subjects with anti-HBs antibody concentrations ³ 100 mIU/ml at all time points. -· To evaluate the safety and reactogenicity of the HB-AS02V vaccine after each dose and per subject. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
· Subjects who 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 adult aged between 18 and 40 years, inclusive, of age at the time of the first vaccination. · Written informed consent obtained from the subject · Healthy subjects as established by medical history and clinical examination before entering into the study. · 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 |
· Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. · Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. (For corticosteroids, this will mean prednisone, or equivalent, superior or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed). · Planned administration/ administration of a vaccine not foreseen by the study protocol within 14 days (killed vaccine) or 30 days (attenuated/ live vaccine) before the first vaccine dose. · Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device). · Prior vaccination against hepatitis B. · History of hepatitis B infection. · Known exposure to hepatitis B virus within 6 months. · Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. · History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. · 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 °C. · Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. · Pregnant or lactating female. · Female planning to become pregnant or planning to discontinue contraceptive precautions.
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E.5 End points |
E.5.1 | Primary end point(s) |
· Anti-HBs seroprotection rates (percentage of subjects with anti-HBs antibody concentrations superior or equal to 10 mIU/ml) 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 | 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) | 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 | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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) | Information not present in EudraCT |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
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 | |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |