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)
Study design: A subset of 20,169 infants were followed for 1 year in a randomized, double-blind, placebo-controlled study conducted in 11 countries in Latin America comparing ROTARIX (n=31,673) vs placebo (n=31,552). The first dose was given at 6 to 13 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. [1]
ROTARIX demonstrated no evidence of interference in immune response to any of the vaccine antigens recommended for infants by the ACIP/AAP/AAFP*†[1]
* PEDIARIX® [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed,
Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined], 7-valent
pneumococcal conjugate vaccine, Hib conjugate vaccine.
† Advisory Committee on Immunization Practices/American Academy of Pediatrics/American
Academy of Family Physicians.
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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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