CTRI/2012/02/002454已完成4 期
Comparison of immunogenicity of a 3 dose and a 5 dose schedule of oral rotavirus vaccine in south Indian infants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 90
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
- •: Child <7 weeks attending Well Baby Clinic at CMC for routine EPI immunization
- •Born after a gestational period of 36-42 weeks with birth weight >=2 kg;
- •Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF) and available for follow up
排除标准
- •: Child not meeting criteria for routine EPI immunization
- •History of congenital abdominal disorders, intussusception, or abdominal surgery;
- •Known or suspected impairment of immunological function;
- •Known hypersensitivity to any component of the rotavirus vaccine;
- •Prior receipt of any rotavirus vaccine;
- •Fever, with axillary temperature >=38.1oC (>=100.5oF); measured by study staff.
- •History of known rotavirus disease, chronic diarrhea, or failure to thrive;
- •Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);
- •Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study)
研究者
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