CTRI/2016/04/006826尚未招募4 期
â??Comparative evaluation of immunogenicity of bivalent oral poliovirus vaccine (bOPV) and monovalent oral poliovirus vaccine type 1 (mOPV1) when administered in the EPI schedule with a dose of inactivated polio vaccine (IPV) at week 14 and assessment of immunogenicity of IPV only schedule in the EPI: A multicentric open label randomized controlled trialâ?? - WHO mOPV1 study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •1.Full term more then 37weeks healthy newborn delivered by a normal vaginal delivery or LSCS at the study site hospital
- •2.Birth weight of ï?³ 2.5 kilograms
- •3.Apgar score ï?³ 9 at 5 minutes
- •4.Residing within a relatively short and easily accessible distance less then 30 km
- •5.Judged to be able to attend all scheduled study visits and comply with the study procedures
- •6.Parent or Legally Acceptable Representative provides written informed consent for the babyâ??s inclusion in the study
排除标准
- •1.Not fulfilling any of the inclusion criteria
- •2.Any diagnosed/suspected medical condition or congenital defect which requires active management or hospitalization; as judged by the investigator
- •3.A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family)
- •4.Thrombocytopenia or a bleeding disorder
研究者
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