Rotavirus vaccine (RotaTeq).

RotaTeq is a live, oral, pentavalent human-bovine reassortant rotavirus vaccine approved for use in the prevention of G1-G4 rotavirus gastroenteritis in infants and children. Rotavirus vaccine demonstrated good immunogenicity in healthy infants. Three oral doses of rotavirus vaccine had a protective efficacy against G1-G4 rotavirus gastroenteritis of any severity of 74%, and a protective efficacy against severe G1-G4 rotavirus gastroenteritis of 98%, in the randomized, double-blind, placebo-controlled, multicenter REST (Rotavirus Efficacy and Safety Trial) study; the per-protocol efficacy analysis included &gt;4500 infants. Healthcare resource use was reduced by rotavirus vaccine, with a 94.5% reduction in the incidence of hospitalization or emergency department care because of G1-G4 rotavirus gastroenteritis. This analysis of the REST trial included >57,000 infants. Rotavirus vaccine did not increase the risk of intussusception within 42 days of any dose, according to an analysis of the REST trial including almost 70,000 infants. Rotavirus vaccine and placebo were associated with serious adverse events in <3% of infants in either group.

RCT Entities:   Population Interventions Outcomes