EUCTR2016-000598-19-FI进行中（未招募）1 期
Immunogenicity and safety study of two formulations of GlaxoSmithKline (GSK) Biologicals’ human rotavirus (HRV) vaccine (444563), in healthy infants starting at age 6-12 weeks. - ROTA-081
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,600
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’ parent(s)/LAR(s) who, in the opinion of the investigator can and will comply with the requirements of the protocol.
- •Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- •A male or female infant between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first study vaccination.
- •Born full-term (i.e., between a gestation period of 37 weeks 0 days and 41 weeks 6 days).
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 1600
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Child in care
- •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-29 to Day 0), or planned use during the study period.
- •Chronic administration of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone (0.5 mg/kg/day, or equivalent). Inhaled and topical steroids are allowed.
- •Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •Administration of long-acting immune-modifying drugs at any time during the study period.
- •Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose of vaccine administration and ending at Visit 3, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study and other licensed routine childhood vaccinations.
- •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.
- •Uncorrected congenital malformation of the gastrointestinal tract that would predispose for Intussusception (IS).
- •History of IS.
- •Family history of congenital or hereditary immunodeficiency.
- •Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •Major congenital defects or serious chronic illness.
- •Previous vaccination against RV.
- •Previous confirmed occurrence of RVGE.
- •GE within 7 days preceding the study vaccine administration.
- •History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
- •Hypersensitivity to latex.
- •Acute disease and/or fever at the time of enrolment.
- •-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, the axilla and the rectum.
- •-Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator
研究者
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