Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study

摘要: Summary Background We aimed to assess the efficacy of oral live attenuated human rotavirus vaccine Rotarix (RIX4414) for prevention gastroenteritis in European infants during their first 2 years life. Methods 3994 study participants were enrolled from six countries and randomly assigned two doses either RIX4414 (n=2646) or placebo (n=1348), which coadministered with specific childhood vaccinations. Follow-up episodes was undertaken weeks post-dose through consecutive seasons following vaccinations (combined follow-up period; mean duration 17 months [SD 1·6]). Our primary endpoint against any severity period (2 end season). Stool specimens obtained tested by ELISA typed RT-PCR. Episodes scoring 11 greater on 20-point Vesikari scale classified as severe. Analysis according protocol. This is registered ClinicalTrials.gov, number NCT00140686 (eTrack102247). Findings 120 excluded according-to-protocol analysis. During (mean 5·7 1·2]), 24 2572 allocated versus 94 1302 given had severity, resulting a 87·1% (95% CI 79·6–92·1; p Interpretation In setting, vaccines provided high protection severe gastroenteritis, an overall reduction admissions over epidemic seasons.