Comparative evaluation of immunogenicity and reactogenicity of bivalent oral poliovirus vaccine (bOPV) and trivalent oral poliovirus vaccine (tOPV) in the standard EPI schedule, with or without inactivated polio vaccine (IPV) administration at DTP3 contact: A randomized controlled trial - WHO EPI Study

World health Organization0 个研究点目标入组 900 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Full term ( >37 weeks) healthy newborn delivered by a normal vaginal delivery or LSCS at the study site hospital
•2.Birth weight of >2.5 kg and Apgar score >9 at 5 min
•3.Residing within a relatively short and easily accessible distance ( < 30 km)
•4.Judged to be able to attend all scheduled study visits and comply with the study procedures
•5.Parent or Legally Acceptable Representative (LAR) provides written informed consent or oral witnessed consent for the babyâ??s inclusion

•1.Preterm (gestation age 37 weeks) baby or high risk delivery
•2.Birth weight 2.5 kg or Apgar score at 5 min 9
•3.Any diagnosed/suspected medical condition or congenital defect which requires active management or hospitalization; as judged by the investigator
•4.Residence 30 km from study site
•5.Baby and the family expected not to be available for the study visits during the study period
•6.Parent/LAR does not consent for their babyâ??s participation
•7.A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family)
•8.Thrombocytopenia or a bleeding disorder

发起方