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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,500
Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine
Centre for Vaccine Studies, Prasanna School of Public Health, Manipal University, Manipal,
Udupi, Karnataka, India
KEM Hospital Research Centre
Pune, Maharashtra, India
Bharati Vidyapeeth Medical College and Hospital, Pune
Pune, Maharashtra, India
Department of community Medicine, Dr Sushila Nayar School of Public Health, Mahatma Gandhi Institute of Medical Sciences, Sewagram
Wardha, Maharashtra, India
Hakeem Abdul Hameed Centenary Hospital
New Delhi, National Capital Territory of Delhi, India
Sri Ramachandra Medical Centre, Chennai
Chennai, Tamil Nadu, India
Institute of Child Health, Kolkata
Kolkata, West Bengal, India
Post Graduate Institute of Medical Education and Research, Chandigarh
Chandigarh, India
Immunogenicity of rotavirus vaccine
Serum anti- rotavirus IgA antibody concentrations expressed as GMCs for the comparison of LBRV-PV vaccine and ROTASIIL
Time frame: 28 days post dose 3
Immunogenicity Endpoints
GMCs of serum anti- rotavirus IgA antibody among the LBRV-PV lots at four weeks after the third vaccination.
Time frame: 28 days post dose 3
Immunogenicity Endpoints
Proportion of subjects achieving IgA antibody concentration ≥20 U/ml for the comparison of LBRV-PV and ROTASIIL.
Time frame: 28 days post dose 3
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