Sheila Isanaka|Ousmane Guindo|Céline Langendorf|Amadou Seck|Brian D. Plikaytis|Nathan Sayinzoga-Makombe|Monica McNeal|Nicole Meyer|Eric Adéhossi|A. Djibo|Bruno Jochum|Rebecca F. Grais
Efficacy of a Low-Cost, Heat-Stable Oral Rotavirus Vaccine in Niger
United Nations Children's Fund Niger|United Nations Children's Fund Niger|United Nations Children's Fund Niger|United Nations Children's Fund Niger|Biostatistical Consulting (United States)|United Nations Children's Fund Niger|Cincinnati Children's Hospital Medical Center|Cincinnati Children's Hospital Medical Center|National Hospital Niamey|Abdou Moumouni University|Médecins Sans Frontières|United Nations Children's Fund Niger
year rotavirus gastroenteritis responsible 37 deaths diarrhea among children younger 5 years age worldwide disproportionate effect subsaharan africawe conducted randomized placebocontrolled trial niger evaluate efficacy live oral bovine rotavirus pentavalent vaccine brvpv serum institute india prevent severe rotavirus gastroenteritis healthy infants received three doses vaccine placebo 6 10 14 weeks age episodes gastroenteritis assessed active passive surveillance graded basis score vesikari scale ranges 0 20 higher scores indicating severe disease primary end point efficacy three doses vaccine compared placebo first episode laboratoryconfirmed severe rotavirus gastroenteritis vesikari score 11 beginning 28 days dose 3among 3508 infants included perprotocol efficacy analysis 31 cases severe rotavirus gastroenteritis vaccine group 87 cases placebo group 214 644 cases per 100 personyears respectively vaccine efficacy 667 95 confidence interval ci 499 779 similar efficacy seen intentiontotreat analyses showed vaccine efficacy 691 95 ci 550 787 significant betweengroup difference risk adverse events reported 687 infants vaccine group 672 placebo group risk serious adverse events 83 vaccine group 91 placebo group 27 deaths vaccine group 22 placebo group none infants confirmed intussusceptionthree doses brvpv oral rotavirus vaccine efficacy 667 severe rotavirus gastroenteritis among infants niger funded mdecins sans frontires operational center kavli foundation clinicaltrialsgov number nct02145000