Contraindications for ROTARIX include a history of any of the following: hypersensitivity to the vaccine or any component of the vaccine, intussusception, uncorrected congenital malformation of the gastrointestinal tract that would predispose the infant to intussusception, or Severe Combined Immunodeficiency Disease (SCID)

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ROTARIX demonstrated efficacy vs placebo in the prevention of rotavirus gastroenteritis (RGE) "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1]

ROTARIX Demonstrated Significant Efficacy in the Prevention of RGE of Any Severity "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1,2]

In a clinical trial studying the prevention of RGE, ROTARIX demonstrated:

87% efficacy in the prevention of RGE of any severity "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1,2]

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 severity "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1]

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 RGE "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1]

Secondary efficacy endpoint through 1 rotavirus season (95% CI: 82, 100) (P<0.001; ATP)

Study design:
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. "toolbar=yes, scrollbars=yes, resizable=yes, width=400, height=400,top=50, left=50"[1,2]

622801R0 July 2016