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
- Conditions
- Rotavirus Gastroenteritis
- Interventions
- Biological: Liquid Rotavirus Vaccine
- Registration Number
- NCT03474055
- Lead Sponsor
- Serum Institute of India Pvt. Ltd.
- 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, 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1500
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ROTASIIL Liquid Rotavirus Vaccine The study participants in this arm will receive ROTASIIL, the licensed lyophilized rotavirus vaccine in India. LBRV-PV Lot A Liquid Rotavirus Vaccine The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot A). LBRV-PV Lot C Liquid Rotavirus Vaccine The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot C). LBRV-PV Lot B Liquid Rotavirus Vaccine The study participants in this arm will receive one of the three liquid rotavirus vaccine lots (LBRV-PV Lot B).
- Primary Outcome Measures
Name Time Method Immunogenicity of rotavirus vaccine 28 days post dose 3 Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL
- Secondary Outcome Measures
Name Time Method Immunogenicity Endpoints 28 days post dose 3 Proportion of subjects achieving IgA antibody concentration ≥20 U/ml for the comparison of LBRV-PV and ROTASIIL.
Trial Locations
- Locations (8)
Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,
🇮🇳Udupi, Karnataka, India
Hakeem Abdul Hameed Centenary Hospital
🇮🇳New Delhi, Delhi, India
Sri Ramachandra Medical Centre, Chennai
🇮🇳Chennai, Tamil Nadu, India
Bharati Vidyapeeth Medical College and Hospital, Pune
🇮🇳Pune, Maharashtra, India
Post Graduate Institute of Medical Education and Research, Chandigarh
🇮🇳Chandigarh, India
KEM Hospital Research Centre
🇮🇳Pune, Maharashtra, India
Institute of Child Health, Kolkata
🇮🇳Kolkata, West Bengal, India
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
🇮🇳Wardha, Maharashtra, India