This is a Phase 3 multicentre, randomized, double blind, placebo-controlled study to determine the effectiveness of the rotavirus vaccine.
The hypothesis is that a three dose series of BRV-PV administered orally to healthy Indian infants, with the initial dose given at 6-8 weeks of age and followed by vaccinations at monthly intervals, will significantly reduce the incidence of severe rotavirus gastroenteritis (SRVGE). Duration of follow-up is until aged 2 years of each enrolled child. The study is powered to detect vaccine efficacy significantly greater than 10% (95% confidence interval lower bound \> 10%) if the true vaccine efficacy is 50% or higher.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
7,500
Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10\^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent
Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents
Dr Dinesh Kumar Government Medical College, Jammu Department of Community Medicine, Government Medical College
Jammu, Jammu and Kashmir, India
Kasturba Medical College, Manipal
Manipal, Karnataka, India
KEM Hospital and Research Centre
Pune, Maharashtra, India
Dr. Sushila Nayar School of Public Health ,Mahatma Ghandi School of Medicine
occurrence of Severe Rotavirus Gastroenteritis
Laboratory confirmed cases of severe rotavirus gastroenteritis occurring in infants receiving the complete vaccination regimen occurring from 14 days after the third vaccine dose until 122 cases are accrued, or until all participating infants reach two years of age (per protocol analysis).
Time frame: Up to 2 years of age of participants
Safety
Occurrence of SAE * Solicited post-vaccination reactions * SAEs * Severe AEs * Unsolicited AEs * Intussusception * Death
Time frame: Until completion of 2 years age of participant
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sewāgrām, Maharashtra, India
Center for Health Research and Development (CHRD) -Society for applied studies (SAS)
New Delhi, National Capital Territory of Delhi, India
National Institute of Cholera & Enteric Diseases
Kolkata, West Bengal, India