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).
The study is designed to evaluate lot-to-lot consistency in the manufacturing of Rotavirus vaccine by testing the vaccine in infants in order to demonstrate equivalence in the induction of specific anti-rotavirus IgA antibodies across three production lots. The study will also examine the potential interference of vaccine with UIP vaccines that will be administered concurrently by assessing non-inferiority in the immune responses to those vaccines when administered with / without the study vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
1,500
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
Gandhi Medical College and Gandhi Hospital
Hyderabad, Andhra Pradesh, India
King George Hospital
Visakhapatnam, Andhra Pradesh, India
JSS Medical College and Hospital
Mysore, Karnataka, India
Rotavirus vaccine lots Immunogenicity
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the BRV-PV to demonstrate equivalence in lot consistency among three lots.
Time frame: Four weeks after the third dose of vaccination
Immunogenicity of UIP vaccines
Time frame: Four weeks after the third dose of vaccination
Immediate adverse events and Solicited post -vaccination reactogenicity
Time frame: AEs within 30 minutes post-vaccination and post vacc reactogenicity during 7 days after each vaccination
Rotavirus Immunogenicity:
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs and proportion of subjects with post-vaccination IgA antibody concentration ≥20 U/ml for the comparison of BRV-PV vaccine and licensed rotavirus vaccine.
Time frame: Four weeks after the third dose of vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)
T. N. Medical College and B. Y. L. Nair Charitable
Mumbai, Maharashtra, India
Seth G S Medical College & KEM Hospital
Mumbai, Maharashtra, India
Bharati Vidyapeeth Medical College and Hospital
Pune, Maharashtra, India
KEM Hospital and Research Centre, Vadu
Pune, Maharashtra, India
Sri Ramachandra Medical Centre
Chennai, Tamil Nadu, India
Institute of Child Health
Kolkata, West Bengal, India
Maulana Azad Medical College
New Delhi, India