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Risks and Side Effects

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

Total vaccinated cohort = all vaccinated infants for whom safety data were available.
n = number of infants for whom at least one symptom sheet was completed.

a Defined as crying more than usual.
b Data not collected in 1 of 7 studies. Dose 1: ROTARIX (n=2853); placebo (n=1897); Dose 2: ROTARIX (n=2522); placebo (n=1863).
c Defined as temperature ≥100.4°F (≥38.0°C) rectally or ≥99.5°F (≥37.5°C) orally.
d Defined as eating less than usual.

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

REFERENCES

  1. Prescribing Information for ROTARIX.
  2. 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.
  3. 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.

Indication

ROTARIX is a vaccine indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) when administered as a 2-dose series. ROTARIX is approved for use in infants 6 weeks to 24 weeks of age.

Important Safety Information

  • 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)
  • The tip caps of the prefilled oral applicators of diluent contain natural rubber latex, which may cause allergic reactions
  • Administration in infants suffering from acute diarrhea or vomiting should be delayed. Safety and effectiveness in infants with chronic gastrointestinal disorders have not been evaluated
  • Safety and effectiveness in infants with known primary or secondary immunodeficiencies have not been established
  • A study conducted after approval of ROTARIX showed an increased risk of intussusception in the 31 days after the first dose of ROTARIX, especially in the first 7 days. In other reports, an increased risk of intussusception has been observed within 7 days after dose 2
  • In clinical studies, common adverse reactions in infants receiving ROTARIX included fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting
  • Vaccination with ROTARIX may not result in protection in all vaccine recipients

Please see full Prescribing Information for ROTARIX.