Objectives The safety and efficacy of RotaTeq was assessed in the Rotavirus Efficacy and Safety Trial (REST) in four continents in approximately 70,000 infants in 2001–2004. Here we report the safety and efficacy results from post-hoc analyses on infants from five European countries.

Methods In Europe, 30,075 healthy infants aged 6–12 weeks received at least one dose of RotaTeq (n = 15,057) or placebo (n = 15,018). They were followed for rotavirus-associated hospitalizations and emergency department (ED) visits for up to two years post-vaccination. In Finland, 2,686 infants (RotaTeq n = 1,344; placebo n = 1,342) were also assessed for clinical efficacy. Rotavirus AGE was defined as vomiting and/or ⩾3 watery stools in 24-hours and detection of virus in stools (ELISA); severity was assessed by a 24-point scale.

Results In 28,002 per protocol evaluable infants, RotaTeq reduced rotavirus-associated hospitalizations and ED visits, for any serotype, by 95% [95% CI: 91 to 97]. Similar results were obtained for infants receiving ⩾one dose (N = 29,565): 92% [95% CI: 89 to 95]. In Finland, RotaTeq prevented severe rotavirus disease due to any serotype by 98% [95% CI: 90 to 100] and for any severity by 68% [95% CI: 60 to 74] in 2,271 per protocol evaluable infants.

Conclusions In Europe, the high and sustainable efficacy of RotaTeq, has been confirmed for severe and any severity rotavirus disease and for reduced hospitalizations and ED visits, for any serotype for up to two years post-vaccination. These findings highlight the value of a universal vaccination program for infants and for the community in terms of potential savings in health resources.