The chart below summarizes the Solicited Adverse Events within 8 days following Doses 1 and 2 of ROTARIX or Placebo (Total Vaccinated Cohort)
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.
| * | Defined as crying more than usual. |
| † | Data not collected in 1 of 7 studies; Dose 1: ROTARIX n = 2,583; placebo n = 1,897; Dose 2: ROTARIX n = 2,522; placebo n = 1,863. |
| ‡ | Defined as temperature ≥100.4°F (≥38.0°C) rectally or ≥99.5°F (≥37.5°C) orally. |
| § | Defined as eating less than usual. |
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Indications and Usage
ROTARIX is 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 in infants and children.
Important Safety Information
- In clinical studies, common adverse events were fussiness/irritability, cough/runny nose, fever, loss of appetite, and vomiting.
- History of uncorrected congenital malformation of the gastrointestinal tract is a contraindication.
- Previous hypersensitivity to any component of ROTARIX, including latex rubber, should be reviewed prior to administration.
- Administration in infants suffering from acute diarrhea or vomiting should be delayed.
- Safety and effectiveness in infants with chronic gastrointestinal disorders, or with known primary or secondary immunodeficiencies, have not been evaluated.
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Download Complete Prescribing Information for ROTARIX |
