EUCTR2017-001220-22-DE进行中（未招募）1 期
A Phase IIIB, randomized, open-label, multicenter clinical trial to assess the immunogenicity and safety of GSK Biologicals’ Herpes Zoster vaccine GSK1437173A when co-administered with Prevenar13 in adults aged 50 years and older. - ZOSTER-059 PRI
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 912
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, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the subject prior to performance of any study specific procedure.
- •A male or female, aged >= 50 YOA at the time of the first vaccination with the study vaccine(s).
- •Female subjects of non-childbearing potential may be enrolled in the study.
- •Female subjects 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 vac-cination, and
- •?has agreed to continue adequate contraception during the entire treatment period and for 2 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 514
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 398
排除标准
- •Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -30 to Day 1), or planned use during the study period.
- •Any medical condition that in the judgment of the investigator would make intramuscular (IM) injection unsafe.
- •Use or anticipated use of immunosuppressants or other immune-modifying drugs during the period starting six months prior to study start and during the whole study period. This includes chronic administration of cortico-steroids (>14 consecutive days of prednisone at a dose of = 20 mg/day [or equivalent]), long-acting immune modifying agents or immunosuppressive/cytotoxic therapy. Inhaled, topical and intra-articular corticosteroids are allowed.
- •Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration. This includes any type of vaccine such as (but not limited to) live, inactivated and subunit vaccines.
- •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 vaccine/product.
- •Previous and/or planned administration of an HZ or VZV vaccine other than the study vaccine during the study period.
- •History of HZ.
- •History of documented pneumococcal infection within 5 previous years.
- •Prior receipt of any pneumococcal vaccine or planned use during the study period, other than the study vaccines.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Acute disease and/or fever at the time of enrollment.
- •?Fever is defined as temperature >= 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity.
- •?Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
- •Administration of immunoglobulins and/or any blood products during the period starting 3 months before 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 before 2 months after the last dose of study vaccine.
- •Any person with cerebrospinal fluid (CSF) leaks, cochlear implants, chronic renal failure, nephrotic syndrome and functional or anatomic asplenia.
- •Any medical condition that in the judgment of the investigator would prevent the subject from participating in the study.
研究者
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