Only ROTARIX® provides completion of recommended rotavirus immunization series by 4 months of age in just 2 oral doses [1,2]
- 90% protection immediately following the first dose and prior to dose 2 [1]
- Significant reduction in hospitalizations [1,3]
- 96% efficacy against G1, 95% efficacy against non-G1 through 1 rotavirus season [1]
- Significant protection sustained through 2 years after vaccination [1]
More on the efficacy of ROTARIX >>
ROTARIX fits into the 2- and 4-month visits [1,4]
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.
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ROTARIX has a proven safety profile [1,5]
- Studied in one of the largest clinical development plans undertaken by a vaccine manufacturer and included data from over 70,000 infants [1]
- In a single study of more than 63,000 infants, no increased risk of intussusception (IS) was observed when compared to placebo (see WARNINGS section 5.5 of Prescribing Information)
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Rotavirus — The most common cause of severe gastroenteritis in infants and young children [2]
Rotavirus Gastroenteritis (RGE) has significant consequences for infants and young children in the US [2]
- Up to 272,000 ED visits and 70,000 hospitalizations annually [2]
- No reliable way to know which infants will have severe disease [2]
RGE is an important cause of hospitalizations [6]
- More than 70% of pediatric hospitalizations for GE are due to rotavirus during peak season [2]
- Children hospitalized for RGE experience significantly longer hospitals stays than those hospitalized for other causes of GE [7]
Hospitalizations for RGE in Children ≤ 5 Years of Age in the US* [7]
*Study conducted in New York State, 1993–2000 data.
Learn more about the symptoms and severity of rotavirusImmunize infants early in life with ROTARIX to help prevent RGE and its consequences.
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 |
