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RotaTeq is indicated for the prevention of rotavirus gastroenteritis (RGE) in infants and children caused by the serotypes G1, G2, G3, and G4 when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. |
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The first dose of RotaTeq should be administered between 6 and 12 weeks of age. |
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In the Rotavirus Efficacy & Safety Trial (REST), RotaTeq did not increase the risk of intussusception relative to placebo.
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In post-marketing experience, cases of intussusception and Kawasaki disease have been reported in infants who have received RotaTeq. |
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RotaTeq demonstrated substantial efficacy against rotavirus gastroenteritis caused by the naturally occurring serotypes G1, G2, G3, and G4.
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| Through the first rotavirus season after vaccination |
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98% efficacy against severe rotavirus gastroenteritis (RGE) (n=5,673) |
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74% efficacy against any severity of RGE (n=5,673) |
| Through the first two years after the third dose |
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96% reduction in hospitalizations due to RGE (n=68,038) |
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94% reduction in emergency department visits due to RGE(n=57,134) 3 |
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Efficacy against any severity of RGE caused by rotavirus serotypes G1, G2, G3, and G4 through the 2 rotavirus seasons after vaccination was 71%. The efficacy of RotaTeq beyond the second season postvaccination was not evaluated. |
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RotaTeq may not protect all vaccine recipients against rotavirus. |
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Over 71,000 infants were evaluated in 3 placebo-controlled clinical trials. Serious adverse events occurred in 2.4% of recipients of RotaTeq when compared to 2.6% of placebo recipients within the 42-day period of a dose of RotaTeq. Hematochezia reported as a serious adverse event for RotaTeq compared to placebo was <0.1% vs <0.1%. The most frequently reported serious adverse events for RotaTeq compared to placebo were bronchiolitis (0.6% vs 0.7%), gastroenteritis (0.2% vs 0.3%), pneumonia (0.2% vs 0.2%), fever (0.1% vs 0.1%), and urinary tract infection (0.1% vs 0.1%). |
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In a subset of more than 11,000 infants in these trials, the presence of adverse events was reported for 42 days after each dose. Fever was observed at similar rates in vaccine and placebo recipients (42.6% vs 42.8%). Adverse events that occurred at a statistically higher incidence within 42 days of any dose among recipients of RotaTeq as compared with placebo recipients were diarrhea (24.1% vs 21.3%), vomiting (15.2% vs 13.6%), otitis media (14.5% vs 13.0%), nasopharyngitis (6.9% vs 5.8%), and bronchospasm (1.1% vs 0.7%). |
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Please read the Select Safety Information. |
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