ROTARIX is the first fully human attenuated rotavirus vaccine[1,2]
ROTARIX demonstrates significant efficacy against severe RGE regardless of serotype [1]
ROTARIX is indicated for the prevention of rotavirus gastroenteritis caused by G1 and non-G1 types (G3, G4, and G9) in infants and children. [1]
In a clinical study, ROTARIX provided significant G1 and non-G1 protection against severe RGE [1]
Study design: A randomized, double-blind, placebo-controlled study was conducted in 6 European countries comparing ROTARIX (n=2,572) vs placebo (n=1,302). The first dose was given at 6 to 14 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. Analysis includes all infants who received 2 doses of vaccine. [1]
P <.05 vs placebo.
Most common rotavirus strains in the US [8]
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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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