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RotaTeq, a pentavalent rotavirus vaccine: efficacy and safety among infants in Europe
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2009 (English)In: Vaccine, ISSN 0264-410X, E-ISSN 1873-2518, Vol. 28, no 2, 345-351 p.Article in journal (Refereed) Published
Abstract [en]

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.

Place, publisher, year, edition, pages
2009. Vol. 28, no 2, 345-351 p.
Keyword [en]
Rotavirus vaccine, Infantile acute gastroenteritis, Randomized controlled trial
National Category
Medical and Health Sciences
URN: urn:nbn:se:umu:diva-35051DOI: 10.1016/j.vaccine.2009.10.041PubMedID: 19879226OAI: diva2:328491
Available from: 2010-07-05 Created: 2010-07-05 Last updated: 2011-12-01Bibliographically approved

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