THIS IS AN OBSERVATIONAL STUDY OF ROTAVIRUS INFECTION IN INFANTS IN PALWAL, HARYANA, INDIA AS A PREPARATION FOR A PROPOSED ROTAVIRUS VACCINE EFFICACY TRIAL.

Not Applicable

Completed

• Registration Number: CTRI/2012/05/002706
• Lead Sponsor: Serum Institute of India Ltd Pune

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

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.

Exclusion Criteria

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

days).

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

study.

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified