ROTARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Efficacy Studies
The data demonstrating the efficacy of ROTARIX in preventing rotavirus gastroenteritis come from 24,163 infants randomized in two placebo-controlled studies conducted in 17 countries in Europe and Latin America. In these studies, oral polio vaccine (OPV) was not coadministered; however, other routine childhood vaccines could be concomitantly administered. Breast-feeding was permitted in both studies.
Efficacy of ROTARIX against any grade of severity of rotavirus gastroenteritis through one rotavirus season was 87.1% (95% CI: 79.6, 92.1); TVC efficacy was 87.3% (95% CI: 80.3, 92.0). Efficacy against severe rotavirus gastroenteritis through one rotavirus season was 95.8% (95% CI: 89.6, 98.7); TVC efficacy was 96.0% (95% CI: 90.2, 98.8) (Table 4). The protective effect of ROTARIX against any grade of severity of rotavirus gastroenteritis observed immediately following dose 1 administration and prior to dose 2 was 89.8% (95% CI: 8.9, 99.8).
Efficacy of ROTARIX in reducing hospitalizations for rotavirus gastroenteritis through one rotavirus season was 100% (95% CI: 81.8, 100); TVC efficacy was 100% (95% CI: 81.7, 100) (Table 4). ROTARIX reduced hospitalizations for all cause gastroenteritis regardless of presumed etiology by 74.7% (95% CI: 45.5, 88.9).
A randomized, double-blind, placebo-controlled study was conducted in 11 countries in Latin America and Finland. A total of 63,225 infants received ROTARIX (n = 31,673) or placebo (n = 31,552). An efficacy subset of these infants consisting of 20,169 infants from Latin America received ROTARIX (n = 10,159) or placebo (n = 10,010). Vaccine or placebo was given to healthy infants as a 2-dose series with the first dose administered orally from 6 through 13 weeks of age followed by one additional dose administered at least 4 weeks after the first dose. The 2-dose series was completed by the age of 24 weeks of age. For both vaccination groups, the racial distribution of the efficacy subset was as follows: Hispanic 85.8%, white 7.9%, black 1.1%, and other 5.2%; 51% were male.
Efficacy of ROTARIX against severe rotavirus gastroenteritis through one year was 84.7% (95% CI: 71.7, 92.4); TVC efficacy was 81.1% (95% CI: 68.5, 89.3) (Table 5).
Efficacy of ROTARIX in reducing hospitalizations for rotavirus gastroenteritis through one year was 85.0% (95% CI: 69.6, 93.5); TVC efficacy was 80.8% (95% CI: 65.7, 90.0).
Patient Advice
Parents or guardians should be informed by the healthcare provider of the potential benefits and risks of immunization with ROTARIX, and of the importance of completing the immunization series.
The healthcare provider should inform the parents or guardians about the potential for 452 adverse reactions that have been temporally associated with administration of ROTARIX or other vaccines containing similar components.
The parent or guardian should immediately report any signs and/or symptoms of intussusception.
The parent or guardian accompanying the recipient should be instructed to report any adverse events to their healthcare provider.
The parent or guardian should be given the Vaccine Information Statements, which are required by the National Childhood Vaccine Injury Act of 1986 to be given prior to immunization. These materials are available free of charge at the Centers for Disease Control and Prevention (CDC) website (www.cdc.gov/vaccines).
Source:
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM133539.pdfCONTRAINDICATIONSA
