Comparison of antibody response in children given 3 or 5 doses of an oral rotavirus vaccine

Phase 4

Completed

• Registration Number: CTRI/2012/02/002454
• Lead Sponsor: Christian Medical College

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: 90

Inclusion Criteria

: Child <7 weeks attending Well Baby Clinic at CMC for routine EPI immunization

Born after a gestational period of 36-42 weeks with birth weight >=2 kg;

Father, mother or other legally acceptable representative (guardian) properly informed about the study and having signed the informed consent form (ICF) and available for follow up

Exclusion Criteria

: Child not meeting criteria for routine EPI immunization

History of congenital abdominal disorders, intussusception, or abdominal surgery;

Known or suspected impairment of immunological function;

Known hypersensitivity to any component of the rotavirus vaccine;

Prior receipt of any rotavirus vaccine;

Fever, with axillary temperature >=38.1oC (>=100.5oF); measured by study staff.

History of known rotavirus disease, chronic diarrhea, or failure to thrive;

Clinical evidence of active gastrointestinal illness (infants with GERD can participate in the study so long as this condition is well controlled with or without medication);

Receipt of any IM, oral, or IV corticosteroid treatment in the past 30 days (infants on inhaled steroids may be permitted to participate in the study)

Study & Design

• Study Type: Interventional
• Study Design: Not specified