CTRI/2017/02/007793尚未招募4 期
Comparative evaluation of immunogenicity of various schedules and delivery options to provide fractional Dose Inactivated Poliovirus Vaccine in routine immunization in the post tOPV-bOPV period: A multi-centric open label randomized controlled trialâ??(India fractional dose IPV study) - WHO fIPV study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 800
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.All infants visiting study site immunization clinic for OPV1/Penta1 immunization
- •2.The infant should be 6-7 completed weeks of age at OPV1/Penta1 contact
- •3.Infants with documentary evidence having taken birth dose of bOPV
- •4.Weight at enrolment visit of >= 3.2 Kgs
- •5.Judged to be healthy by the investigator for study participation
- •6.Parents judged to be able to attend all scheduled study visits and comply with the study procedures
- •7.Parent or Legally Acceptable Representative (LAR) 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.Taken any polio vaccine/s other than birth dose of bOPV
- •3.Any diagnosed/suspected medical condition which requires active management or hospitalization; as judged by the investigator
- •4.A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family)
- •5.Thrombocytopenia or a bleeding disorder
研究者
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