CTRI/2014/04/004548已完成4 期
Phase IV, multicenter, randomized, single-blind, study to evaluate the immunogenicity, reactogenicity & safety of the live attenuated rotavirus vaccine ROTAVAC® as a 3 dose series when administered simultaneously with or without the buffering agent following in healthy infants - ROTAVAC®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
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 of at least 3kg at birth.
- •4.Infants received EPI vaccines at birth.
- •5.Parental ability and willingness to provide informed consent and possible to contact on Phone.
- •6.Parent who intends to remain in the area with the child during the study period.
排除标准
- •1.Presence of diarrhoea 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.Acute disease at the time of enrolment (temporary exclusion).
- •4.Concurrent participation in another clinical trial throughout the entire timeframe of this study.
- •5.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.
- •6.History of congenital abdominal disorders, intussusception, abdominal surgery
- •7.Known or suspected impairment of immunological function based on medical history and physical examination.
- •8.Household contact with an immunosuppressed individual or pregnant woman.
- •9.Prior receipt of rotavirus vaccine.
- •10.A known sensitivity or allergy to any components of the study medication.
- •11.Major congenital or genetic defect.
- •12.History of persistent diarrhoea (defined as diarrhoea more than 14 days).
- •13.Participantâ??s parents not able, available or willing to accept active weekly follow-up by the study staff.
- •14.Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period.
- •15.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.
- •16.History of any neurologic disorders or seizures.
- •17.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 or a participantâ??s parentâ??s/legally acceptable representativeâ??s ability to give informed consent.
研究者
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