CompletedPhase 3

Phase III Study on Rotavirus Vaccine to Evaluate Lot-to-lot Consistency and Interference With Routine UIP Immunization

India1,500 participantsStarted 2015-11

Plain-language summary

This is a Phase 3, open-label, randomized study to evaluate lot-to-lot consistency in the manufacture of Bovine Rotavirus Pentavalent Vaccine (BRV-PV).

Who can participate

Age range6 Weeks – 8 Weeks

SexALL

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Inclusion criteria

✓. Healthy infants as established by medical history and clinical examination before entering the study.
✓. Age: 6-8 weeks at the time of enrollment.
✓. Parental ability and willingness to provide written informed consent.
✓. Parent who intends to remain in the area with the child during the study period.
✓. Receipt of birth dose of Hepatitis B vaccine and OPV.

Exclusion criteria

✕. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment (temporary exclusion).
✕. Presence of fever on the day of enrollment (temporary exclusion).
✕. Acute disease at the time of enrollment (temporary exclusion).
✕. Concurrent participation in another clinical trial at any point throughout the entire timeframe for this study.
✕. Presence of significant malnutrition or any systemic disorder as determined by medical history and / or physical examination which would compromise the subject's health or is likely to result in nonconformance to the protocol.
✕. History of congenital abdominal disorders, intussusception, or abdominal surgery.
✕. Known or suspected impairment of immunological function based on medical history and physical examination.
✕. Household contact with an immunosuppressed individual or pregnant woman.

What they're measuring

Rotavirus vaccine lots Immunogenicity

Timeframe: Four weeks after the third dose of vaccination

Immunogenicity of UIP vaccines

Timeframe: Four weeks after the third dose of vaccination

Trial details

NCT IDNCT02584816

SponsorSerum Institute of India Pvt. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-04

View on ClinicalTrials.gov More Rotavirus Gastroenteritis trials