PROSPECTIVE OBSERVATIONAL STUDY OF ROTAVIRUS INFECTION IN INFANTS IN SANGAM VIHAR, DELHI, 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: 2021年11月24日

试验速览

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•For all participants:
•healthy infants as established by medical history and clinical examination before entering into the study.
•Parental / legal guardian ability and willingness to provide informed consent.
•Parental / legal guardian who will remain in the area during the study period.
•Additional criteria for cohort 1:
•Age: 6-8 weeks at the time of enrollment.
•Additional criteria for cohort 2:
•Age: 8-12 months at the time of enrollment.

•Presence of diarrhea or vomiting in the previous 24 hours or on the day of enrolment (temporary exclusion).
•Presence of high fever on the day of enrolment (temporary exclusion).
•History of congenital abdominal disorders, intussusception, abdominal surgery or any other congenital disorder.
•Known or suspected impairment of immunological function based on medical history and physical examination.
•Subjects who have received rotavirus vaccine.
•History of chronic diarrhea (defined as diarrhea more than 14 days).
•Subject parents who will not be available or willing for active weekly follow-up by the study staff.
•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 study.
•History of any neurologic disorders or seizures.
•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.

发起方

Serum Institute of India Ltd Pune