title: RotaTeq, a pentavalent rotavirus vaccine: efficacy and safety among infants in Europe.
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.
authors.affiliation: University of Tampere Medical School, Tampere, Finland. timo.vesikari@uta.fi
authors.forename: Timo
authors.initials: T
authors.lastname: Vesikari
authors.forename: Robbin
authors.initials: R
authors.lastname: Itzler
authors.forename: Aino
authors.initials: A
authors.lastname: Karvonen
authors.forename: Tiina
authors.initials: T
authors.lastname: Korhonen
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.forename: Ulrich
authors.initials: U
authors.lastname: Behre
authors.forename: Gianni
authors.initials: G
authors.lastname: Bona
authors.forename: Leif
authors.initials: L
authors.lastname: Gothefors
authors.forename: Penny M
authors.initials: PM
authors.lastname: Heaton
authors.forename: Michael
authors.initials: M
authors.lastname: Dallas
authors.forename: Michelle G
authors.initials: MG
authors.lastname: Goveia
mesh_terms: D005060:Europe; D005759:Gastroenteritis / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D006801:Humans; D007223:Infant; D012400:Rotavirus Infections / Q000276:immunology / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000009:adverse effects / Q000627:therapeutic use*; D014613:Vaccines, Attenuated / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated