OBJECTIVES: Rotavirus is the most common cause of gastroenteritis in young children worldwide, resulting in a high burden of disease. The objective of this study was to evaluate the effects of vaccinating infants with a pentavalent rotavirus vaccine, RotaTeq®, in Germany. METHODS: Using a decision analytic model a birth cohort of 705,622 newborns was followed from birth up to 5 years of age. Total societal cost associated with rotavirus gastroenteritis in this cohort was calculated. Potential costs and benefits of a universal rotavirus vaccination programme were assessed. Input parameters were derived from a German prospective epidemiological study ("REVEAL study"), national statistics and published literature. Efficacy of RotaTeq® (prevention of 86% office visits, of 96% hospitalisations) was based on a large clinical trial ("REST Efficacy Study", Phase III). Main outcome measures were cases avoided, total societal direct and indirect disease costs and vaccination expenditures of Sickness Funds (administration fees & vaccine costs). Cost per avoided case was used as a measure of cost-effectiveness. In addition, the number needed to vaccinate (NNV) was calculated. RESULTS: A rotavirus vaccination programme with a coverage rate of 90% would prevent in total about 325,565 cases of rotavirus infections in Germany (-75%) and the huge burden of human suffering behind these cases. Total societal costs associated with paediatric rotavirus gastro-enteritis are estimated at €119.2 million. The vaccination programme with cost of €117.2 million could reduce the societal disease costs by €91.8 million (-77%). This leads to costs per hospitalised case avoided of €1405.70 and a NNV of 35 infants. To avoid 1 general practitioner / paediatrician case the NNV is 6 with costs per case prevented of €191.90. CONCLUSION: Implementing a rotavirus vaccination programme in Germany with RotaTeq® will significantly and efficiently decrease the morbidity and associated burden due to rotavirus infections in young children. -2007-->