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临床试验/ACTRN12623001320640
ACTRN12623001320640尚未招募Unknown

Impact of IPV on mucosal immunity: A randomized controlled trial comparing nasopharyngeal and intestinal poliovirus shedding after bOPV challenge in IPV recipients with those not receiving IPV

World Health Organization0 个研究点目标入组 400 人开始时间: 2023年12月15日最近更新:

试验速览

阶段
Unknown
状态
尚未招募
入组人数
400

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Prevention
盲法
Open (masking not used)

入排标准

年龄范围
6 Months 至 8 Months(—)
性别
All

入选标准

  • 1.Healthy infants born June-August 2023 (i.e, 6-8 months of age at time of enrolment in February 2024) residing in Camaguey province of Cuba
  • 2.Over the 3rd percentile for height and weight
  • 3.Resident of the study locality for more than or at least 5 months, with no plans to move
  • 4.Previously received one dose of fIPV in primary series at 4 months of age
  • 5.Parent/guardian consent for participation in the study and for samples collection

排除标准

  • 1.Infant not fulfilling inclusion criteria
  • 2.Contraindication for venepuncture
  • 3.Having received bOPV or 2nd fIPV dose before enrolment
  • 4.Acutely sick child or child requiring hospitalization. These children will be referred to the nearest medical facility equipped to handle the case at their own expense.
  • 5.Diagnosis or suspicion in the subject or an immediate family member of congenital medical conditions (e.g., Down Syndrome); primary immunodeficiency disorder; chronic medical illness (e.g., renal, cardiac)
  • 6.Infants of mothers below the legal age (<18 years) or with mental incapacity will not be eligible to participate.

研究者

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