EUCTR2015-001545-81-Outside-EU/EEA进行中（未招募）不适用
A Phase IV, double-blind, randomised, placebo-controlled study to evaluate immunogenicity, reactogenicity and safety of GlaxoS-mithKline (GSK) Biologicals’ oral live attenuated HRV vaccine in healthy infants previously uninfected with HRV. - Rota-068 PRI
适应症
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
- 684
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 their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •-A male or female between, and including, 6 to 12 weeks of age at the time of the first dose of the vaccination.
- •-Written informed consent obtained from the parents or guardians of the subject.
- •-Healthy subjects as established by medical history and clinical examination before entering into the study.
- •-Born after a normal gestation period of between 37 and 41 weeks + 6 days inclusive.
- •-Subjects for whom the vaccination history is available from vaccination diary cards or medical charts.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 684
- •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
- •-Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the 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 since birth.
- •-Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine with the exception of the routine infant 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 product.
- •-Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- •-Any clinically significant history of chronic gastrointestinal disease including any uncorrected congenital malformation of the gastrointestinal tract or other serious medical condition as determined by the investigator.
- •-History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- •-Acute disease at the time of enrolment.
- •-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
- •-Gastroenteritis (GE) within 7 days preceding the study vaccine administration.
- •-Previous confirmed occurrence of RV GE.
- •-Previous vaccination with rotavirus vaccine or planned use during the study period.
研究者
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