ACTRN12611001212943已完成2 期
A Phase IIa double-blind, randomised, placebo controlled study of the immunogenicity, safety, tolerability and reactogenicity of three doses of oral RV3-BB Rotavirus Vaccine, with the first dose of vaccine administered either at birth (0-5 days of age) or in infancy.
Murdoch Children's Research Institute (MCRI)0 个研究点目标入组 93 人开始时间: 2011年11月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 93
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- Days 至 5 Days（—）
- 性别
- All
入选标准
- •healthy, full-term infant, 0-5 days of age.
排除标准
- •Moderate or severe illness, major congenital malformations or genetically determined disease, known or suspected disease of the immune system, household member with severe immunosuppression, exposure to the following in the 4 weeks prior to enrolment (including gestation): glucocorticosteroids, cytotoxic drugs or blood products.
- •Intent to immunise with an investigational vaccine (during the study), or other rotavirus vaccine.
研究者
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