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Human Vaccines & Immunotherapeutics Volume 14, 2018 - Issue 7
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Research Papers

A Phase 4, multicentre, randomized, single-blind clinical trial to evaluate the immunogenicity of the live, attenuated, oral rotavirus vaccine (116E), ROTAVAC®, administered simultaneously with or without the buffering agent in healthy infants in India

Raches EllaBharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, India
,
Radhika BobbaBharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, India
,
Sanjay MuralidharBharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, India
,
Sudhir BabjiDivision of Gastrointestinal Sciences, Christian Medical College, Vellore, Tamil Nadu, India
,
Krishna Mohan VadrevuBharat Biotech International Limited, Genome Valley, Shameerpet, Hyderabad, IndiaCorrespondence[email protected]
&
Maharaj Kishan BhanIndian Institute of Technology, Government of India, Delhi, India
Pages 1791-1799 | Received 03 Nov 2017, Accepted 07 Mar 2018, Published online: 12 Apr 2018

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Krishna Kumari P, Siddharth Reddy Chiteti, Vinay K. Aileni, Sudhir Babji$suffix/text()$suffix/text(), William C. Blackwelder, Ashok Kumar, Jayant Vagha, Uma Nayak, Monjori Mitra, Narayanaappa D, Sonali Kar, Sangeeta Yadav, Swamy Naidu, Niranjan Mahantshetti, Vasant Khalatkar, Satyajit Mohapatra, P. K. Purthi, Pawan Sharma, A. Kannan, Ramchandra Keshav Dhongade, Sai D. Prasad, Raches Ella & Krishna Mohan Vadrevu. (2023) 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. Human Vaccines & Immunotherapeutics 19:3.
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Annika Skansberg, Molly Sauer, Marissa Tan, Mathuram Santosham & Mary Carol Jennings. (2021) Product review of the rotavirus vaccines ROTASIIL, ROTAVAC, and Rotavin-M1. Human Vaccines & Immunotherapeutics 17:4, pages 1223-1234.
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Yuxiao Wang, Jingxin Li, Pei Liu & Fengcai Zhu. (2021) The performance of licensed rotavirus vaccines and the development of a new generation of rotavirus vaccines: a review. Human Vaccines & Immunotherapeutics 17:3, pages 880-896.
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Pooja Dewan & H. P. S. Sachdev. (2021) Research for Improving Patient Care. Indian Pediatrics 58:4, pages 377-382.
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Jason M. Mwenda, Inácio Mandomando, Khuzwayo C. Jere, Nigel A. Cunliffe & A. Duncan Steele. (2019) Evidence of reduction of rotavirus diarrheal disease after rotavirus vaccine introduction in national immunization programs in the African countries: Report of the 11th African rotavirus symposium held in Lilongwe, Malawi. Vaccine 37:23, pages 2975-2981.
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