Phase III randomized clinical studies to evaluate the immunogenicity, lot-to-lot consistency, and safety of ROTAVAC® liquid formulations (ROTAVAC 5C & 5D) and non-inferiority comparisons with licensed ROTAVAC® (frozen formulation) in healthy infants

• Main Authors: Krishna Kumari P (Author), Siddharth Reddy Chiteti (Author), Vinay K. Aileni (Author), Sudhir Babji (Author), William C. Blackwelder (Author), Ashok Kumar (Author), Jayant Vagha (Author), Uma Nayak (Author), Monjori Mitra (Author), Narayanaappa D (Author), Sonali Kar (Author), Sangeeta Yadav (Author), Swamy Naidu (Author), Niranjan Mahantshetti (Author), Vasant Khalatkar (Author), Satyajit Mohapatra (Author), P. K. Purthi (Author), Pawan Sharma (Author), A. Kannan (Author), Ramchandra Keshav Dhongade (Author), Sai D. Prasad (Author), Raches Ella (Author), Krishna Mohan Vadrevu (Author)
• Format: Book
• Published: Taylor & Francis Group, 2023-12-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

ABSTRACTThe WHO pre-qualified rotavirus vaccine, ROTAVAC®, is derived naturally from the neonatal 116E rotavirus strain, and stored at −20°C. As refrigerator storage is preferable, immunogenicity and safety of liquid formulations kept at 2-8°C, having excipients to stabilize the rotavirus, with or w...