87% efficacy in the prevention of RGE of any severity1,2
Primary efficacy endpoint from 2 weeks after the second dose through 1 rotavirus season (95% CI: 80, 92) (P<0.001 vs placebo; according to protocol [ATP])
90% first-dose efficacy in the prevention of RGE of any severity1
Secondary efficacy endpoint immediately following dose 1 and prior to dose 2 (95% CI: 9, 100) (total vaccinated cohort)
100% efficacy in reducing hospitalizations for RGE1
Secondary efficacy endpoint through 1 rotavirus season (95% CI: 82, 100) (P<0.001; ATP)
A randomized, double-blind, placebo-controlled study was conducted in 6 European countries comparing ROTARIX (n=2572) vs placebo (n=1302). The first dose was given at 6-14 weeks of age, and the second dose was given at least 4 weeks after the first dose. The 2-dose series was completed by 24 weeks of age. Analysis of the ATP cohort included all infants in the efficacy cohort who received 2 doses of vaccine according to randomization.1,2
- Prescribing Information for ROTARIX.
- Vesikari T, Karvonen A, Prymula R, et al. Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study. Lancet. 2007;370:1757-1763.
- Centers for Disease Control and Prevention. Recommended Immunization Schedules for Persons Aged 0 Through 18 Years—United States, 2016. http://www.cdc.gov/vaccines/schedules/downloads/child/0-18yrs-child-combined-schedule.pdf. Accessed November 26, 2019.