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.
P KK, Chiteti SR, Aileni VK, Babji S (late), Blackwelder WC, Kumar A, Vagha J, Nayak U, Mitra M, D N, Kar S, Yadav S, Naidu S, Mahantshetti N, Khalatkar V, Mohapatra S, Purthi PK, Sharma P, Kannan A, Dhongade RK, Prasad SD, Ella R, Vadrevu KM.
P KK, et al.
Hum Vaccin Immunother. 2023 Dec 15;19(3):2278346. doi: 10.1080/21645515.2023.2278346. Epub 2023 Nov 15.
Hum Vaccin Immunother. 2023.
PMID: 37968237
Free PMC article.
Clinical Trial.
As it was separately established that buffers are not required for ROTAVAC, in Study-2, the safety and immunogenicity of ROTAVAC 5D (with excipients) were compared with ROTAVAC and lot-to-lot consistency was assessed in another study. All lots elicited consistent immune re …
As it was separately established that buffers are not required for ROTAVAC, in Study-2, the safety and immunogenicity of ROTAVAC 5D ( …