CTRI/2016/11/007481已完成3 期
A phase III, multicenter, randomized, open labeled study to evaluate the immunogenicity, reactogenicity and safety of ROTAVAC 5CM of the live attenuated rotavirus vaccine as a 3 dose series when compared with existing ROTAVAC® in healthy infants aged 6-8 weeks - ROTAVAC5CM
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
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
- •3.Weight: >=2.5 kgs at birth and >=4 kgs at the time of enrollment/randomization
- •4. Infants received age-appropriate UIP vaccines till enrolment and during the study.
- •5.Parental ability and willingness to provide informed consent.
- •6.Parent who intends to remain in the area with the subject during the study period.
排除标准
- •1.Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion).
- •2.Presence of fever on the day of enrolment (temporary exclusion).
- •3.Concurrent participation in another clinical trial.
- •4.Presence of significant malnutrition or any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, haematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the childâ??s health or is likely to result in non-conformance to the protocol.
- •5.History of congenital abdominal disorders, intussusception, abdominal surgery
- •6.Prior receipt of rotavirus vaccine.
- •7.A known sensitivity or allergy to any components of the study vaccines.
- •8.Major congenital or genetic defect.
- •9.History of persistent diarrhea (defined as diarrhea of more than 14 days).
- •10.Subjectâ??s parents not able, available or willing to accept active follow-up by the study staff.
- •11.Has received any immunoglobulin therapy and/or blood products since birth.
- •12.History of chronic administration (defined as more than 14 days) of immunosuppressantâ??s including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study, at the discretion of the principal investigator.
- •13.History of any neurologic disorders or seizures.
- •14.Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence.
- •15. Asubjectâ??s parentâ??s/legally acceptable representativeâ??s inability to give informed consent.
研究者
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