The integrated phase III safety profile of the pentavalent human-bovine (WC3) reassortant rotavirus vaccine

Background: Rotavirus gastroenteritis is a significant cause of morbidity and mortality. Objective: To perform an integrated safety analysis of data from the Phase III studies of the pentavalent rotavirus vaccine (PRV). Methods: Healthy 6- to 12-week-old infants received 3 doses of PRV or placebo at 4- to 10-week intervals in 3 Phase 111, blinded, randomized, placebo-controlled trials. Active surveillance for serious adverse events (AE), including intussusception, was performed at 7, 14, and 42 days after each dose. Other AEs occurring within 42 days after each dose were documented on Vaccination Report Cards. Fecal shedding of vaccine-virus strains was evaluated by plaque assay and electropherotyping. Conclusions: Across the 3 Phase III clinical trials, PRV was welt tolerated, with no increased clinical risk of intussusception. Fecal shedding of vaccine-virus strains occurred infrequently and in tow amounts, suggesting the risk of transmission is unlikely. (c) 2007 International Society for Infectious Diseases. Published by Elsevier Ltd. All rights reserved.