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
在健康婴儿中开展 III 期随机临床研究,以评估 ROTAVAC® 液体制剂(ROTAVAC 5C 和 5D)的免疫原性、批间一致性和安全性,并与已获许可的 ROTAVAC®(冷冻制剂)进行非劣效性比较。
期刊:Human Vaccines & Immunotherapeutics
影响因子:3.5
doi:10.1080/21645515.2023.2278346
P, Krishna Kumari; Chiteti, Siddharth Reddy; Aileni, Vinay K; Babji, Sudhir (late); Blackwelder, William C; Kumar, Ashok; Vagha, Jayant; Nayak, Uma; Mitra, Monjori; D, Narayanaappa; Kar, Sonali; Yadav, Sangeeta; Naidu, Swamy; Mahantshetti, Niranjan; Khalatkar, Vasant; Mohapatra, Satyajit; Purthi, P K; Sharma, Pawan; Kannan, A; Dhongade, Ramchandra Keshav; Prasad, Sai D; Ella, Raches; Vadrevu, Krishna Mohan