ROTARIX offers sustained efficacy against common and emerging serotypes
Through 2 seasons after vaccination, ROTARIX demonstrated significant serotype-specific efficacy against severe RGE for ALL 5 of the most common strains in the US [1,3,8]
Efficacy Through 2 Rotavirus Seasons in a Clinical Study
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.
Only ROTARIX is indicated to protect against G9—an emerging strain associated with severe disease [1,2,8,10-13]
- During US CDC surveillance, G9 fluctuated in prevalence by 61% over a period of 3 years* [8]
- G9 caused 50% of rotavirus disease in Philadelphia in the 1995-1996 season [12]
- In a study in Europe, G9 increased from 4.8% prevalence (1999-2000) to 51.5% prevalence (2002-2003) [13]
* Calculation was based on a decrease in prevalence from 7.7% (1996-1997) to 3.0% (1998-1999).
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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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