Rotavirus vaccines in clinical development: Current pipeline and state-of-the-art.

Rotavirus (RV) disease is a leading cause of mortality and morbidity, especially in children under 5 years of age. The introduction of the two oral rotavirus vaccines Rotarix® and RotaTeq® has shown significant reductions in RV-related mortality, severe RV disease, and hospitalizations. However, some barriers, including a reduced efficacy in low-income countries, safety issues regarding the intussusception risk, age restrictions on vaccine use, the live-attenuated nature itself, and the substantial vaccine costs, currently restrict the full potential of RV disease prevention. Therefore, research is now focusing on the implementation of new oral vaccines and the development of parenteral vaccines to overcome these limits. This review provides an overview of the new rotavirus vaccines in clinical development and the ongoing clinical trials on new RV vaccines in the pediatric age.