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

Research output: Contribution to journal › Article › 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.

Original language	English
Pages (from-to)	345-351
Number of pages	7
Journal	Vaccine
Volume	28
Issue number	2
DOIs	https://doi.org/10.1016/j.vaccine.2009.10.041
Publication status	Published - 11 Dec 2009
Externally published	Yes

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

SDG 3 Good Health and Well-being

Keywords

Infantile acute gastroenteritis
Randomized controlled trial
Rotavirus vaccine

Access to Document

10.1016/j.vaccine.2009.10.041

Cite this

@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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JO - Vaccine

JF - Vaccine

IS - 2

ER -