OBSERVATIONAL STUDY OF ROTAVIRUS INFECTIONS IN INFANTS IN VADODARA, GUJARAT, INDIA TO PREPARE FOR A PLANNED ROTAVIRUS VACCINE TRIA
- Registration Number
- CTRI/2012/07/002824
- Lead Sponsor
- Serum Institute of India Ltd Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢ To determine the feasibility of recruiting infants and enrolling them into the study, following them up and retaining them in the study, and to detect cases of acute infantile diarrhea during the prospective observational study, over a 6 month period per child. <br/ ><br>â?¢ To develop, assess and train staff in appropriate operations and procedures to be employed in the proposed future rotavirus efficacy trial.Timepoint: For 6 Months
- Secondary Outcome Measures
Name Time Method 1.To ascertain community understanding, <br/ ><br>acceptance and support for the future efficacy <br/ ><br>trial. <br/ ><br>2.To understand the barriers and limitations for <br/ ><br>enrolling infants in the proposed rotavirus <br/ ><br>vaccine efficacy trial, and the primary causes of <br/ ><br>loss to follow-up of the infants.Timepoint: For 6 Months