CTRI/2010/091/000204已完成3 期
Comparative Study to Evaluate the Safety and Immunogenicity of Bharat Biotech Bivalent Oral Poliomyelitis Vaccine Type1 & 3, Live (Oral) Vs Reference Vaccine. (Non- inferiority trial)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 288
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Written and signed informed consent by subject parents or legally acceptable guardian.
- •2.Healthy male or female full term neonate aged less than three hours at time of enrollment.
- •3.The delivery was not high-risk
- •4.The APGAR score was greater than 7 when measure 1 minute after birth
- •5.Subjects should have been born after 36-week term and are not less than 2500 gms, at the time of inclusion.
- •6.Family does not plan to move during the study period, and housed not further that 50 km away from the study site.
排除标准
- •1)Fever of any origin or infections.
- •2)Any confirmed or suspected immunosuppressive condition.
- •3)Any treatment with immunosuppressive or immuno stimulant therapy
- •4)Use of any marketed or investigational medicine or non-registered drug or vaccine for polio.
- •5)Any criteria, which in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
研究者
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