Vaccine
Volume 27, Issue 43, Pages 5921-6102 (9 October 2009)
http://www.sciencedirect.com/science/journal/0264410X

Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: Randomised, double-blind, controlled study
Pages 5936-5941
K.B. Phua, F.S. Lim, Y.L. Lau, E.A.S. Nelson, L.M. Huang, S.H. Quak, B.W. Lee, Y.L. Teoh, H. Tang, I. Boudville, L.C. Oostvogels, P.V. Suryakiran, I.V. Smolenov, H.H. Han, H.L. Bock

Abstract
This study evaluates the safety and efficacy against severe rotavirus gastroenteritis of the oral live attenuated human rotavirus vaccine RIX4414 (Rotarix™) during the first 2 years of life in Asian infants from high-income countries. Healthy infants were enrolled to receive 2 doses of RIX4414 (N = 5359) or placebo (N = 5349). From 2 weeks post-dose 2 to 2 years of age, vaccine efficacy was 96.1% (95%CI:85.1%; 99.5%) against severe rotavirus gastroenteritis, 100% (95%CI:80.8%; 100%) against wild-type G1P[8] and 93.6% (95%CI:74.7%; 99.3%) against circulating non-G1 rotavirus types. No intussusception cases were reported within 31 days post-vaccination. RIX4414 shows a good safety profile and offers high protection during the first 2 years of life with potentially significant public health impact in this population.