Status:
COMPLETED
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
Lead Sponsor:
Serum Institute of India Pvt. Ltd.
Conditions:
Rotavirus Gastroenteritis
Eligibility:
All Genders
6-8 years
Phase:
PHASE2
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 25 2018
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT03474055
Start Date
October 30 2017
End Date
June 25 2018
Last Update
September 10 2018
Active Locations (8)
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1
Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,
Udupi, Karnataka, India, 576104
2
KEM Hospital Research Centre
Pune, Maharashtra, India, 411028
3
Bharati Vidyapeeth Medical College and Hospital, Pune
Pune, Maharashtra, India, 411043
4
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
Wardha, Maharashtra, India, 442102