EUCTR2012-005671-14-GB进行中（未招募）1 期
A phase III, randomised, open-label, multicentre clinical trial to assess the safety and immunogenicity of GSK Biologicals’ HZ/su candidate vaccine when administered subcutaneously as compared to intramuscularly according to a 0,2-month schedule in adults aged 50 years and older. - ZOSTER-032
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,082
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
- •Subject who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Subject, if residing in Japan, is of Japanese ethnic origin, defined as having been born in Japan with four ethnic Japanese grandparents and able to speak Japanese.
- •Subject, if not residing in Japan, may be of any ethnic origin.
- •Subject has provided written informed consent.
- •Subject, male or female, who is 50 YOA or older at the time of the first vaccination.
- •Subject, if female, of non-childbearing potential may be enrolled in the study.
- •-Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
- •Subject, if female, of childbearing potential may be enrolled in the study, if the subject:
- •-has practiced adequate contraception for 30 days prior to vaccination, and
- •-has a negative pregnancy test on the day of vaccination, and
- •-has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series (i.e., for 2 months after Month 2).
- •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 650
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 432
排除标准
- •Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- •Concurrently participating or planned participation 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).
- •Administration or planned administration of a live vaccine within 30 days prior to the first study vaccination through 30 days after the second study vaccination.
- •Administration or planned administration of a non-replicating vaccine within 8 days prior to or within 14 days after either dose of study vaccine.
- •Planned administration, during the study, of an HZ or varicella vaccine (including an investigational or non-registered vaccine) other than the study vaccine.
- •Administration of immunoglobulins and/or any blood products within the three (3) months preceding the first dose of study vaccine or planned administration during the study period.
- •Chronic administration (defined as > 14 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- •-For corticosteroids, a prednisone dose of < 20 mg/day, or equivalent, is allowed.
- •-Inhaled, topical, and intra-articular corticosteroids are allowed.
- •Administration or planned administration of long-acting immune-modifying drugs (e.g., infliximab) within six months prior to the first vaccine dose through the duration of the study period.
- •History of HZ.
- •Previous vaccination against HZ or varicella (registered or investigational product).
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine or study material and equipment.
- •Significant underlying illness that, in the opinion of the investigator, would be expected to prevent completion of the study (e.g., life-threatening disease likely to limit survival to less than 1 year).
- •Any other condition that, in the opinion of the investigator, might interfere with the evaluations required by the study.
- •Acute disease and/or fever at the time of vaccination:
- •-Fever is defined as temperature = 37.5°C (99.5°F) for oral, axillary, or tympanic route, or = 38.0°C/100.4°F for rectal route. The preferred route for recording temperature in this study will be oral.
- •-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator.
- •Pregnant or lactating female.
- •Female planning to become pregnant or planning to discontinue contraceptive precautions (if of childbearing potential) through Month 4 (i.e., 2 months after the second dose of study vaccine).
研究者
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