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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Autores principales: 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: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier Science 2018
Materias:
Article
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6288065/
https://www.ncbi.nlm.nih.gov/pubmed/30420116
http://dx.doi.org/10.1016/j.vaccine.2018.11.006

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