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RotaTeq, a pentavalent rotavirus vaccine: efficacy and safety among infants in Europe.
Vaccine. 2009 Dec 11; 28(2):345-51.V

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.

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Authors+Show Affiliations

Vesikari T
University of Tampere Medical School, Tampere, Finland. timo.vesikari@uta.fi
Itzler R
No affiliation info available
Karvonen A
No affiliation info available
Korhonen T
No affiliation info available
Van Damme P
No affiliation info available
Behre U
No affiliation info available
Bona G
No affiliation info available
Gothefors L
No affiliation info available
Heaton PM
No affiliation info available
Dallas M
No affiliation info available
Goveia MG
No affiliation info available

MeSH

EuropeGastroenteritisHumansInfantRotavirus InfectionsRotavirus VaccinesVaccines, Attenuated

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19879226

Citation

Vesikari, Timo, et al. "RotaTeq, a Pentavalent Rotavirus Vaccine: Efficacy and Safety Among Infants in Europe." Vaccine, vol. 28, no. 2, 2009, pp. 345-51.
Vesikari T, Itzler R, Karvonen A, et al. RotaTeq, a pentavalent rotavirus vaccine: efficacy and safety among infants in Europe. Vaccine. 2009;28(2):345-51.
Vesikari, T., Itzler, R., Karvonen, A., Korhonen, T., Van Damme, P., Behre, U., Bona, G., Gothefors, L., Heaton, P. M., Dallas, M., & Goveia, M. G. (2009). RotaTeq, a pentavalent rotavirus vaccine: efficacy and safety among infants in Europe. Vaccine, 28(2), 345-51. https://doi.org/10.1016/j.vaccine.2009.10.041
Vesikari T, et al. RotaTeq, a Pentavalent Rotavirus Vaccine: Efficacy and Safety Among Infants in Europe. Vaccine. 2009 Dec 11;28(2):345-51. PubMed PMID: 19879226.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - RotaTeq, a pentavalent rotavirus vaccine: 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, Y1 - 2009/10/29/ PY - 2009/06/29/received PY - 2009/09/28/revised PY - 2009/10/12/accepted PY - 2009/11/3/entrez PY - 2009/11/3/pubmed PY - 2010/3/4/medline SP - 345 EP - 51 JF - Vaccine JO - Vaccine VL - 28 IS - 2 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. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/19879226/RotaTeq_a_pentavalent_rotavirus_vaccine:_efficacy_and_safety_among_infants_in_Europe_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0264-410X(09)01571-0 DB - PRIME DP - Unbound Medicine ER -