EUCTR2005-004057-98-CZ进行中（未招募）不适用
A phase III, single centre, double blind, randomised study evaluating the consistency of three lots of Henogen’s new adjuvanted hepatitis B vaccine HB-AS02V, when administered according to a 0, 1 month schedule in healthy volunteers aged 18 years to 40 years. - HN016/HBV-002
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Henogen
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •·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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·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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