Background-While the pentavalent rotavirus vaccine was highly efficacious against rotavirus diarrhea in clinical trials, the vaccine's effectiveness under field conditions in the developing world is unclear. In October, 2006, Nicaragua became the first developing nation to implement universal infant immunization with the pentavalent rotavirus vaccine. To assess the impact of the immunization program, we examined the incidence of diarrhea episodes between 2003 and 2009 among children in the state of León, Nicaragua.