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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

BACKGROUND: A heat-stable bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was developed in India. In this study, the vaccine was tested for safety, immunogenicity and clinical lot-to-lot consistency. METHODS: This was a Phase III, open label, randomized, equivalence design...

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Detalhes bibliográficos
Publicado no:Vaccine
Main Authors: 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
Formato: Artigo
Idioma:Inglês
Publicado em: Elsevier Science 2018
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC6288065/
https://ncbi.nlm.nih.gov/pubmed/30420116
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1016/j.vaccine.2018.11.006
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