TY - JOUR
T1 - RotaTeq®, a pentavalent rotavirus vaccine
T2 - Efficacy and safety among infants in Europe
AU - Vesikari, Timo
AU - Itzler, Robbin
AU - Karvonen, Aino
AU - Korhonen, Tiina
AU - Van Damme, Pierre
AU - Behre, Ulrich
AU - Bona, Gianni
AU - Gothefors, Leif
AU - Heaton, Penny M.
AU - Dallas, Michael
AU - Goveia, Michelle G.
N1 - Funding Information:
REST was funded by Merck & Co; RotaTeq ® is a vaccine commercialized in Europe by Sanofi Pasteur MSD and elsewhere by Merck & Co.
PY - 2009/12/11
Y1 - 2009/12/11
N2 - 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.
AB - 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.
KW - Infantile acute gastroenteritis
KW - Randomized controlled trial
KW - Rotavirus vaccine
UR - https://www.scopus.com/pages/publications/70649099048
U2 - 10.1016/j.vaccine.2009.10.041
DO - 10.1016/j.vaccine.2009.10.041
M3 - Article
SN - 0264-410X
VL - 28
SP - 345
EP - 351
JO - Vaccine
JF - Vaccine
IS - 2
ER -
