EUCTR2008-006083-11-CZ进行中（未招募）不适用
An open multicentre, multicountry study to evaluate long-term antibody persistence and immune memory between Years 11 and 15 after the primary study HAB-084 in which healthy adolescents were vaccinated with Twinrix™ Adult following a two-dose schedule or Twinrix™ Junior following a three-dose schedule. - HAB-084 EXT:Y11 to Y15 + BST
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 241
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
- •All subjects must satisfy the following criteria at entry into each of the time-points of the long-term follow-up phase:
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study HAB-084.
- •Written informed consent obtained from the subject.
- •All subjects must satisfy the following criteria at entry into the challenge dose phase:
- •A male or female who received the complete primary vaccination course according to his/her group allocation in the primary study HAB-084.
- •Subjects who participated in the long-term follow-up phase of the HAB-084 study and for whom the antibody concentrations were below 15 mIU/ml for anti-HAV antibodies and/ or 10 mIU/ml for anti-HBs antibodies at the last available follow-up time-points.
- •Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- •Written informed consent obtained from the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the challenge dose phase of this study.
- •If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam; Norplant® or DepoProvera®) for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination.
- •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 241
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The following criteria should be checked at each follow-up visit. If any apply at study entry, the subject must not be included at that long-term follow-up visit.
- •Use of any investigational or non-registered product (drug or vaccine) since the last blood sampling visit.
- •Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine since the primary vaccination course of the study HAB-084.
- •History of hepatitis A or hepatitis B infection.
- •Administration of hepatitis A or hepatitis B immunoglobulins and/or any blood products within 3 months prior to blood sampling.
- •The following criteria should be checked before the challenge dose phase. If any apply, the subject must not be included in the challenge dose phase:
- •Use of any investigational or non-registered product (drug or vaccine) within 30 days before the administration of the challenge dose or planned use during the study period outside the context of the study.
- •Administration of a hepatitis A, hepatitis B or hepatitis combination vaccine between the primary vaccination course of the study HAB-084 and the challenge dose visit.
- •History of hepatitis A or hepatitis B infection.
- •Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the challenge dose. (For corticosteroids, this will mean prednisone, or equivalent, ? 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- •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 temperature <37.5°C/ Axillary temperature <37.5°C).
- •Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the challenge dose or planned administration before the final blood sampling point (one month after the challenge dose).
- •Pregnant or lactating female.
研究者
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