OBJECTIVE: To review the clinical efficacy, safety, and pharmacoeconomic data about the use of rhesus–human reassortant rotavirus tetravalent vaccine (RRV-TV) in infants and children. DATA SOURCES: A MEDLINE search (January 1990–December 1998) was conducted to identify all publications on the RRV-TV vaccine including pharmacology, clinical trials, adverse effects, and pharmacoeconomics in infants and children. Bibliographies of articles were also used. STUDY SELECTION: All randomized and placebo-controlled clinical efficacy trials were reviewed. Additionally, pharmacoeconomic studies focusing on the potential impact on healthcare costs were chosen for review. DATA SYNTHESIS: Rotavirus-induced gastroenteritis is a significant problem in developed and developing countries. Various forms of a rotavirus vaccine have been studied worldwide. The tetravalent vaccine appears to have similar efficacy in developed and developing countries. It seems to be most effective against the most severe forms of gastroenteritis, with an 80% overall efficacy rate. This vaccine is well tolerated; the most common adverse effect is fever after the first dose. Pharmacoeconomic studies indicate that although the vaccine may be only moderately effective against less severe gastroenteritis, over $1 billion annually could potentially be saved in the US with its universal use. CONCLUSIONS: The new rotavirus vaccine is effective in preventing and reducing the incidence of rotavirus-induced gastroenteritis. The morbidity, mortality, and healthcare costs from this disease may be reduced if this vaccine is provided to children worldwide.