RotaTeq, a pentavalent rotavirus vaccine: efficacy and safety among infants in Europe.
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.
Vesikari
Timo
T
University of Tampere Medical School, Tampere, Finland. timo.vesikari@uta.fi
Itzler
Robbin
R
Karvonen
Aino
A
Korhonen
Tiina
T
Van Damme
Pierre
P
Behre
Ulrich
U
Bona
Gianni
G
Gothefors
Leif
L
Heaton
Penny M
PM
Dallas
Michael
M
Goveia
Michelle G
MG
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
C492535:RotaTeq; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated