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...

وصف كامل

محفوظ في:
التفاصيل البيبلوغرافية
الحاوية / القاعدة:Vaccine
المؤلفون الرئيسيون: 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
التنسيق: Artigo
اللغة:Inglês
منشور في: Elsevier Science 2018
الموضوعات:
Article
الوصول للمادة أونلاين: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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