ISRCTN80143849已完成不适用
Comparative evaluation of immunogenicity of Monovalent Type 1 Oral Poliovirus Vaccine (mOPV1) versus trivalent OPV (tOPV): a randomised double-blind trial set in India (Panacea Biotec Ltd mOPV1 study)
Panacea Biotec Ltd (India)0 个研究点目标入组 600 人开始时间: 2006年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 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
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Healthy newborns (greater than or equal to 2.75 kg birth weight, apgar score at 5 minutes, greater than or equal to 9) at the study site(s) (large maternity hospitals)
- •2. Residing within a relatively short and easily accessible distance (less than 30 km)
- •3. Not planning to travel away during entire the study period (birth - 2 months)
排除标准
- •1. Newborns requiring hospitalisation
- •2. Birth weight below 2.75 kg
- •3. Apgar score at 5 minutes less than 9
- •4. Residence greater than 30 km from study site
- •5. Families expecting to be absent during the 60-day study period
- •6. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study
研究者
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