Pentavalent human-bovine reassortant rotavirus vaccine: a review of its efficacy and safety in preventing acute rotavirus gastroenteritis in healthy infants.

Acute rotavirus gastroenteritis can be successfully managed with oral and intravenous rehydration solutions; however, it is still a major cause of childhood mortality and morbidity in developing countries and is responsible for significant morbidity and health-care costs in developed countries. Pentavalent human-bovine rotavirus vaccine (HBRV) is an oral vaccine containing five live attenuated human-bovine reassortant strains containing the human serotypes responsible for the majority of rotavirus cases worldwide. Approximately three-quarters of all acute rotavirus gastroenteritis cases and almost all cases of severe gastroenteritis were prevented by pentavalent HBRV in a phase III clinical trial. Pentavalent HBRV has a favorable safety profile, with fever, irritability, vomiting and diarrhea generally reported in similar proportions of infants who received either vaccine or placebo. Results from a large phase III study indicate that there was no excess risk of intussusception among those vaccinated compared with placebo recipients. This review summarizes the current data on the clinical efficacy and safety of HBRV in healthy infants.