CTRI/2010/091/000591已完成3 期
COMPARATIVE EVALUATION OF IMMUNOGENICITY AND REACTOGENICITY OF BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from Sanofi Pasteur bulk) VERSUS PRE QUALIFIED BIVALENT ORAL POLIOVIRUS VACCINE (bOPV from PT BioFarma bulk): A RANDOMIZED DOUBLE-BLIND TRIA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 272
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
入选标准
- •Infants between 6 weeks to 10 weeks of age born healthy (2.50 kg birth weight,) and has received a single birth dose of tOPV at least 4 weeks before, residing within a relatively short and easily accessible distance ( <30 km), and not planning to travel away during the entire study period (birth-1 months)
排除标准
- •Newborns requiring hospitalization, birth weight below 2.50 kg, residence >30 km from study site, or families expecting to be absent during the 30-day study period. 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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