CTRI/2012/05/002706已完成未知
PROSPECTIVE OBSERVATIONAL STUDY OF ROTAVIRUS INFECTION IN INFANTS IN PALWAL, HARYANA, INDIA TO PREPARE FOR A PROPOSED ROTAVIRUS VACCINE EFFICACY TRIA
Serum Institute of India Ltd Pune0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •For all participants:
- •1. Healthy infants as established by medical history and clinical
- •examination before entering into the study.
- •2. Parental / legal guardian ability and willingness to provide
- •informed consent.
- •3. Parent / legal guardian who will remain in the area during the
- •study period.
- •Additional criteria for cohort 1:
- •4. Age: 6-8 weeks at the time of enrollment.
- •Additional criteria for cohort 2:
- •5. Age: 8-12 months at the time of enrollment.
排除标准
- •1. Presence of diarrhea or vomiting in the previous 24 hours or on
- •the day of enrolment (temporary exclusion).
- •2. Presence of high fever on the day of enrolment (temporary
- •exclusion).
- •3. History of congenital abdominal disorders, intussusception,
- •abdominal surgery or any other congenital disorder.
- •4. Known or suspected impairment of immunological function based
- •on medical history and physical examination.
- •5. Subjects who have received rotavirus vaccine.
- •6. History of chronic diarrhea (defined as diarrhea more than 14
- •7. Subject parents who will not be available or willing for active
- •weekly follow-up by the study staff.
- •8. Chronic administration (defined as more than 14 days) of
- •immunosuppressants including corticosteroids since birth. Infants on
- •inhaled or topical steroids may be permitted to participate in the
- •9. History of any neurologic disorders or seizures.
- •10. Any medical condition in the parents / legal guardian / infants
- •that, in the judgment of the investigator, would interfere with or
- •serves as a contraindication to protocol adherence or a participantâ??s
- •ability to give informed consent.
研究者
相似试验
已完成
不适用
OBSERVATIONAL STUDY OF ROTAVIRUS INFECTIONS IN INFANTS IN VADODARA, GUJARAT, INDIA TO PREPARE FOR A PLANNED ROTAVIRUS VACCINE TRIACTRI/2012/07/002824Serum Institute of India Ltd Pune200
已完成
不适用
PROSPECTIVE OBSERVATIONAL STUDY OF ROTAVIRUS INFECTION IN INFANTS IN SANGAM VIHAR, DELHI, INDIA TO PREPARE FOR A PROPOSED ROTAVIRUS VACCINE EFFICACY TRIACTRI/2012/06/002715Serum Institute of India Ltd Pune200
已完成
不适用
PROSPECTIVE OBSERVATIONAL STUDY OF ROTAVIRUS INFECTION IN INFANTS IN SEWAGRAM, MAHARASHTRA, INDIA TO PREPARE FOR A PROPOSED ROTAVIRUS VACCINE EFFICACY TRIACTRI/2012/05/002675Serum Institute of India Ltd Pune800
已完成
3 期
ong-term Persistence of Rotavac@birth phase 3 study in neonates and infantsCTRI/2020/10/028458Bharat Biotech International Limited
已完成
不适用
Prospective Study in Respiratory Syncytial Virus Infected Japanese Adults, in Outpatient and Inpatient Settingsacute respiratory infectionJPRN-UMIN000019120Janssen Pharmaceutica NV100