RotaTeq®, a pentavalent rotavirus vaccine: Efficacy and safety among infants in Europe

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

doi:10.1016/j.vaccine.2009.10.041

RotaTeq^®, a pentavalent rotavirus vaccine: Efficacy and safety among infants in Europe

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

Risultato della ricerca: Contributo su rivista › Articolo in rivista › peer review

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.

Lingua originale	Inglese
pagine (da-a)	345-351
Numero di pagine	7
Rivista	Vaccine
Volume	28
Numero di pubblicazione	2
DOI	https://doi.org/10.1016/j.vaccine.2009.10.041
Stato di pubblicazione	Pubblicato - 11 dic 2009
Pubblicato esternamente	Sì

OSS delle Nazioni Unite

Questo processo contribuisce al raggiungimento dei seguenti obiettivi di sviluppo sostenibile

SDG 3 Salute e benessere

Accesso al documento

10.1016/j.vaccine.2009.10.041

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Cita questo

@article{7b57e3ff076445aa9f847c3f961f4e32,

title = "RotaTeq{\textregistered}, a pentavalent rotavirus vaccine: Efficacy and safety among infants in Europe",

abstract = "A pentavalent human-bovine reassortant oral rotavirus vaccine, RotaTeq{\textregistered}, 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{\textregistered} 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{\textregistered} and placebo for any of the safety outcomes. In Europe, RotaTeq{\textregistered} was highly efficacious and well tolerated.",

keywords = "Infantile acute gastroenteritis, Randomized controlled trial, Rotavirus vaccine",

author = "Timo Vesikari and Robbin Itzler and Aino Karvonen and Tiina Korhonen and \{Van Damme\}, Pierre and Ulrich Behre and Gianni Bona and Leif Gothefors and Heaton, \{Penny M.\} and Michael Dallas and Goveia, \{Michelle G.\}",

note = "Funding Information: REST was funded by Merck \& Co; RotaTeq {\textregistered} is a vaccine commercialized in Europe by Sanofi Pasteur MSD and elsewhere by Merck \& Co. ",

year = "2009",

month = dec,

day = "11",

doi = "10.1016/j.vaccine.2009.10.041",

language = "English",

volume = "28",

pages = "345--351",

journal = "Vaccine",

issn = "0264-410X",

publisher = "Elsevier Ltd.",

number = "2",

}

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

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EP - 351

JO - Vaccine

JF - Vaccine

IS - 2

ER -