Safety Profile for ROTARIX
Solicited Adverse Events
- In 7 clinical studies, detailed safety information was collected by parents/guardians for 8 consecutive days following vaccination with ROTARIX1
- Solicited adverse events among recipients of ROTARIX and placebo occurred at similar rates1
SOLICITED ADVERSE EVENTS WITHIN 8 DAYS FOLLOWING DOSES 1 AND 2 OF ROTARIX OR PLACEBO (TOTAL VACCINATED COHORT)1
Unsolicited Adverse Events
- Infants were monitored for unsolicited serious and nonserious adverse events that occurred in the 31-day period following vaccination in 7 clinical studies (ROTARIX [n=5082]; placebo [n=2902])1
- The following adverse events occurred at a statistically higher incidence among recipients of ROTARIX compared with placebo: irritability (ROTARIX=11.4%, placebo=8.7%) and flatulence (ROTARIX=2.2%, placebo=1.3%)1
- 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.