Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency… (NCT03474055) | Clinical Trial Compass
CompletedPhase 2/3
Study on Liquid Bovine Rotavirus Pentavalent Vaccine (LBRV-PV) to Evaluate Lot-to-Lot Consistency and to Compare Non-Inferiority With ROTASIIL (Lyophilized BRV-PV) in Healthy Infants in India
India1,500 participantsStarted 2017-10-30
Plain-language summary
This study has been designed to compare the liquid formulation of BRV-PV (LBRV-PV) with the lyophilized formulation (ROTASIIL) by testing the vaccine in infants (three doses administered 4 weeks apart, starting at 6-8 weeks of age) in order to demonstrate the non-inferiority in the induction of specific anti-rotavirus IgA antibodies by these vaccines. The study will also evaluate lot-to-lot consistency in the manufacture of LBRV-PV by demonstrating equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots.
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 informed consent.
✓. Parent who intends to remain in the area with the child during the study period.
Exclusion criteria
✕. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrollment.
✕. Acute disease at the time of enrollment (temporary exclusion)
✕. Concurrent participation in another clinical trial at any point throughout the entire time frame for this study
✕. History of congenital abdominal disorders, intussusception, or abdominal surgery.
✕. Known or suspected impairment of immunological function based on medical history and physical examination.
. History of any neurologic disorders or seizures.
✕. Any medical condition in the parents / infant which, in the judgment of the Investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parents' ability to give informed consent.