作者
Prasad S Kulkarni, Sajjad Desai, Tushar Tewari, Anand Kawade, Nidhi Goyal, Bishan Swarup Garg, Dinesh Kumar, Suman Kanungo, Veena Kamat, Gagandeep Kang, Ashish Bavdekar, Sudhir Babji, Sanjay Juvekar, Byomkesh Manna, Shanta Dutta, Rama Angurana, Deepika Dewan, Abhijeet Dharmadhikari, Jagdish K Zade, Rajeev M Dhere, Alan Fix, Maureen Power, Vidyasagar Uprety, Varsha Parulekar, Iksung Cho, Temsunaro R Chandola, Vikash K Kedia, Abhishek Raut, Jorge Flores, Hanif Shaikh, Lalit Gupta, Rakesh Patil, Mohd Aslam, Alok Arya, Farhana Rafiqi, Subodh S Gupta, Chetna H Maliye, PV Bahulekar, Kiran Bala, Tajali Nazir Shora, Shahid Hussain, Mihir Kumar Bhattacharya, Ashis K Mukhopadhyay, Dilip Kumar Pal, Jayanta Saha, Ranjitha S Shetty, Muralidhar M Kulkarni, Chythra V Raj
发表日期
2017/10/27
期刊
Vaccine
卷号
35
期号
45
页码范围
6228-6237
出版商
Elsevier
简介
Rotavirus is the most common cause of moderate-to-severe infant diarrhoea in developing countries, resulting in enormous morbidity, mortality, and economic burden. A bovine-human reassortant pentavalent rotavirus vaccine (BRV-PV) targeting the globally most common strains was developed in India and tested in a randomized, double-blind, placebo-controlled end-point driven Phase III efficacy clinical trial implemented at six sites across India. Infants 6 to 8 weeks of age were randomized (1:1) to receive three oral doses of BRV-PV or placebo at 6, 10, and 14 weeks of age along with routine vaccines. Home visit surveillance was conducted to detect severe rotavirus gastroenteritis (SRVGE) and safety outcomes until the children reached two years of age. A total of 3749 infants received BRV-PV while 3751 received placebo. At the time of the primary end-point (when the minimum number of cases needed for …
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PS Kulkarni, S Desai, T Tewari, A Kawade, N Goyal… - Vaccine, 2017