EUCTR2015-001546-28-Outside-EU/EEA进行中（未招募）不适用
Open, multi-centric, post-marketing surveillance (PMS) to evaluate the reactogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine, Rotarix™ when administered according to a 0, 2 month schedule to Sri Lankan infants aged at least 6 weeks at the time of first vaccination. - Rota-069 PMS
Smithkline Beecham Pvt Limited0 个研究点目标入组 522 人开始时间: 2015年6月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 522
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 .
- •A male or female at least 6 weeks of age at the time of the first vaccination.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 522
- •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
- •History of allergic disease or reactions likely to be exac-erbated by any component of the vaccine.
- •Acute disease at the time of enrolment.
- •Any history of uncorrected congenital malformation of the gastrointestinal tract that would predispose for intussusception.
- •Any contraindication as stated in the updated and approved Prescribing Information
研究者
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