Nita Bhandari|Temsunaro Rongsen?Chandola|Ashish Bavdekar|Jacob John|Kalpana Antony|Sunita Taneja|Nidhi Goyal|Anand Kawade|Gagandeep Kang|Sudeep Singh Rathore|Sanjay Juvekar|Jayaprakash Muliyil|Alok Arya|Hanif Shaikh|Vinod Joseph Abraham|Sudhanshu Vrati|Michael A. Proschan|Robert Kohberger|Georges Thiry|Roger I. Glass|Harry B. Greenberg|George T. Curlin|Krishna Mohan|G.V.J.A. Harshavardhan|Sai Prasad|T. Srinivasa Rao|John W. Boslego|Maharaj Kishan Bhan
Efficacy of a monovalent human-bovine (116E) rotavirus vaccine in Indian infants: a randomised, double-blind, placebo-controlled trial
Society for Applied Studies|Society for Applied Studies|Christian Medical College & Hospital|Program for Appropriate Technology in Health|Society for Applied Studies|Society for Applied Studies|Christian Medical College & Hospital|Society for Applied Studies|Christian Medical College & Hospital|Society for Applied Studies|Christian Medical College & Hospital|Translational Health Science and Technology Institute|National Institutes of Health|National Institutes of Health|Stanford University|National Institutes of Health|Bharat Biotech (India)|Bharat Biotech (India)|Bharat Biotech (India)|Government of India|Program for Appropriate Technology in Health|Government of India|Ministry of Science and Technology
rotavirus common cause severe dehydrating gastroenteritis developing countries safe effective affordable rotavirus vaccines needed countries aimed assess efficacy tolerability monovalent humanbovine rotavirus vaccine severe rotavirus gastroenteritis lowresource urban rural settings indiawe randomised doubleblind placebocontrolled multicentre trial three sites delhi urban pune rural vellore urban rural march 11 2011 nov 5 2012 infants aged 67 weeks randomly assigned 21 via central interactive voice web response system block size 12 receive either three doses oral humanbovine natural reassortant vaccine 116e placebo ages 67 weeks 10 weeks 14 weeks infants families study investigators paediatricians referral hospitals laboratory staff committee members masked treatment allocation primary outcome incidence severe rotavirus gastroenteritis 11 vesikari scale efficacy outcomes adverse events ascertained active surveillance analysis intention treat per protocol trial registered clinical trial registryindia ctri2010091000102 clinicaltrialsgov nct013051094532 infants assigned receive 116e vaccine 2267 receive placebo 4354 96 2187 96 infants respectively included primary perprotocol efficacy analysis 71 events severe rotavirus gastroenteritis reported 4752 personyears infants vaccine group compared 76 events 2360 personyears placebo group vaccine efficacy severe rotavirus gastroenteritis 536 95 ci 350669 p00013 564 366701 p00001 first year life number infants needed immunised prevent one severe rotavirus gastroenteritis episode 55 95 ci 3797 incidence severe rotavirus gastroenteritis per 100 personyears 15 vaccine group 32 placebo group incidence rate ratio 046 95 ci 033065 prevalence immediate solicited serious adverse events similar groups one case urticaria vaccine group one acute gastroenteritis suspected sepsis placebo group regarded related study product recorded six cases intussusception vaccine group two placebo group happened third dose 25 1 infants vaccine group 17 1 placebo group died death regarded related study productmonovalent humanbovine 116e rotavirus vaccine effective well tolerated indian infantsdepartment biotechnology biotechnology industry research assistance council government india bill melinda gates foundation path usa research council norway uk department international development national institutes health bethesda usa bharat biotech international hyderabad india