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临床试验/ISRCTN54186735
ISRCTN54186735已完成不适用

A phase-IV randomised, double blind comparative evaluation of immunogenicity of Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1) versus trivalent OPV (tOPV): four-armed study

Panacea Biotec Limited (India)0 个研究点目标入组 720 人开始时间: 2007年9月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
720

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

性别
All

入选标准

  • 1. Healthy infants (greater than or equal to 2.5 kg birth weight, apgar score at 5 minutes greater than or equal to 9)
  • 2. Born at study sites (maternity hospitals)
  • 3. Residing less than 30 km away from study site
  • 4. Not planning to travel during entire study period (birth to 2 months)

排除标准

  • 1. Newborns requiring hospitalisation
  • 2. Birth weight less than 2.5 kg
  • 3. Apgar score at 5 minutes less than 9
  • 4. Residence greater than 30 km from study sites
  • 5. Families expecting to be absent during the 60 day study period
  • 6. A diagnosis or suspicion of immunodeficiency disorder (either in participant or immediate family member)

研究者

发起方
Panacea Biotec Limited (India)

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