A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants
一项 III 期开放标签、随机、活性对照临床研究,旨在评估牛-人重组五价轮状病毒疫苗在印度婴儿中的安全性、免疫原性和批间一致性。
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doi:10.1016/j.vaccine.2018.11.006
Rathi, Niraj; Desai, Sajjad; Kawade, Anand; Venkatramanan, Padmasani; Kundu, Ritabrata; Lalwani, Sanjay K; Dubey, A P; Venkateswara Rao, J; Narayanappa, D; Ghildiyal, Radha; Gogtay, Nithya; Venugopal, P; Palkar, Sonali; Munshi, Renuka; Kang, Gagandeep; Babji, Sudhir; Bavdekar, Ashish; Juvekar, Sanjay; Ganguly, Nupur; Niyogi, Prabal; Ghosh Uttam, Kheya; Rajani, H S; Kondekar, Alpana; Kumbhar, Dipti; Mohanlal, Smilu; Agarwal, Mukesh C; Shetty, Parvan; Antony, Kalpana; Gunale, Bhagwat; Dharmadhikari, Abhijeet; Tang, Yuxiao; Kulkarni, Prasad S; Flores, Jorge