Vaccine
Volume 28, Issue 2, Pages 291-582 (11 December 2009)

RotaTeq®, a pentavalent rotavirus vaccine: Efficacy and safety among infants in Europe
Pages 345-351
Timo Vesikari, Robbin Itzler, Aino Karvonen, Tiina Korhonen, Pierre Van Damme, Ulrich Behre, Gianni Bona, Leif Gothefors, Penny M. Heaton, Michael Dallas, Michelle G. Goveia

Abstract
A pentavalent human–bovine reassortant oral rotavirus vaccine, RotaTeq®, was evaluated among nearly 70,000 infants in the Rotavirus Efficacy and Safety Trial (REST), of which 30,523 were from Europe. All infants were followed for serious adverse events as well as hospitalizations and emergency department (ED) visits. All adverse events, health care utilization, and RVGE regardless of severity were evaluated in the clinical efficacy cohort (N = 2686) in Finland. RotaTeq® was 98.3% (95% CI, 90.2–100%) and 68.0% (95% CI 60.3–74.4%) efficacious against severe rotavirus gastroenteritis (RVGE) and all RVGE due to any serotype for two rotavirus seasons post-vaccination. The combined rate of hospitalizations and ED visits due to RVGE of any serotype was reduced by 94.5% (95% CI, 91.3–96.8%) for up to 2 years after vaccination. There were no statistically significant differences between RotaTeq® and placebo for any of the safety outcomes. In Europe, RotaTeq® was highly efficacious and well tolerated.