According to the package insert2, from infancy through one year, ROTARIX efficacy against severe rotavirus gastroenteritis was 84.7 percent in infants who received two vaccine doses, and 81 percent among those receiving one dose. ROTARIX efficacy against hospitalizations for rotavirus gastroenteritis through one year was 85 percent in infants receiving two vaccine doses and 80.8 percent among those receiving one dose.
Two studies evaluated the efficacy of ROTARIX against all rotavirus gastroenteritis infections and against severe rotavirus gastroenteritis through two seasons. In the first study, ROTARIX efficacy was reported at 78.9 percent against all rotavirus gastroenteritis through two rotavirus seasons, but only 71.9 percent for cases occurring during the second season after vaccination. Against severe rotavirus gastroenteritis, ROTARIX efficacy through two rotavirus seasons was 90.4 percent, but only 85.6 percent for cases occurring during the second season after vaccination. ROTARIX efficacy in reducing hospitalizations for rotavirus gastroenteritis through two rotavirus seasons was 96 percent.
In the second study, ROTARIX efficacy was reported at 80.5 percent against severe rotavirus gastroenteritis through two rotavirus seasons, and 79 percent for cases occurring during the second season after vaccination. ROTARIX efficacy in reducing hospitalizations for rotavirus gastroenteritis through two rotavirus seasons was 83 percent.
The effectiveness or safety of administering ROTARIX to infants with chronic gastrointestinal disorders or in infants with known primary or secondary immunodeficiencies was not evaluated in clinical trials prior to licensing.
