CTRI/2018/08/015317招募中4 期
Immunogenicity and Safety of Rotavac® and Rotasiil® Administered in an Interchangeable Dosing Schedule among Healthy Indian Infants: A Multicentric, Phase IV, Open-Labeled, Randomized, Controlled Trial - RVICS
试验速览
- 阶段
- 4 期
- 状态
- 招募中
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
- •1.Healthy infants, as established by medical history and clinical examination before entering the study.
- •2.Age: 6-8 weeks at the time of enrollment.
- •3.Parental ability and willingness to provide informed consent.
- •4.Parent who intends to remain in the area with the child during the study period.
排除标准
- •1.Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
- •2.Presence of fever on the day of enrollment (temporary exclusion).
- •3.Acute disease at the time of enrollment (temporary exclusion).
- •4.Concurrent participation in another clinical trial throughout the entire timeframe for this study.
- •5.Presence of significant malnutrition (weight-for-height z-score <-3SD median) or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the subjectâ??s health or is likely to result in nonconformance to the protocol.
- •6.History of congenital abdominal disorders, intussusception or abdominal surgery
- •7.Known or suspected impairment of immunological function based on medical history and physical examination.
- •8.Prior receipt of rotavirus vaccine.
- •9.History of persistent diarrhea (defined as diarrhea more than 14 days).
- •10.Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
- •11.History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study.
- •12.Any medical condition in the parents/infant which, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participantâ??s parents ability to give informed consent.
研究者
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