ROTARIX demonstrated efficacy vs placebo in the prevention of rotavirus gastroenteritis (RGE)1
Significant efficacy through 1 rotavirus season
- 96% efficacy against G1 (95% CI: 86, 100) (P<0.05 vs placebo)1
- 95% efficacy against combined non-G1 (G2, G3, G4, G9) (95% CI: 85, 99) (P<0.05 vs placebo)1
- Efficacy against severe RGE for G2P4 was not significant through 1 season due to fewer episodes of G2 RGE1
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.