CTRI/2015/06/005856已完成4 期
A randomized, open label, multicenter study to evaluate the immunogenicity and safety of BBILs trivalent type 1, 2 & 3 oral polio vaccine - BioPolio
Bharath biotech Int Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Written and signed informed consent by subject parents or legally acceptable guardian.
- •Healthy male or female full term neonate aged less than three hours at time of enrollment.
- •The delivery was not high-risk
- •The APGAR score was greater than 7 when measure 1 minute after birth
- •Subjects should have been born after 36-week term and are not less than 2500 gms, at the time of inclusion.
- •Family does not plan to move during the study period, and housed not further that 50km away from the study site.
排除标准
- •Fever of any origin or infections.
- •Any confirmed or suspected immunosuppressive condition.
- •Any treatment with immunosuppressive or Immuno stimulant therapy
- •Use of any marketed or investigational medicine or non-registered drug or vaccine for polio.
- •Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
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