Abstract

Background and aims: Current rotavirus vaccines have showed outstanding effectiveness in USA, but data coming from Europe are still scarce. Effectiveness of rotavirus vaccination in Spain - where both rotavirus vaccines are available since 2007- has been estimated. Methods: A prospective observational study was conducted from Oct-2008 through Jun-2009 including 682 children up to 5 years-old with AGE attended in primary care (n=18 centres), and ER and hospital settings (n=10 centres), covering Galicia and Asturias regions (North-West Spain). A rapid stool immunochromotagographic test for rotavirus antigen detection (test VIKIA, BioMerieux) was at least performed in all included patients. Rotavirus vaccine global effectiveness was estimated as 1-OR after comparing the frequency of rotavirus vaccination in patients positive and negative to rotavirus etiology. Rotavirus vaccine effectiveness (RVVE) to prevent hospital admission was also calculated. Results: Of 682 enrolled children, 207(30.4%) were rotavirus positive and 152(22%) had received at least one dose of rotavirus vaccine. In 163 patients (24%) hospital admission was required, but patients with rotavirus AGE were admitted to hospital more frequently (47.8%vs14%){p<.001}. RRVE (after at least one vaccine dose) to prevent rotavirus AGE was 90.5%(95%confidence interval: 82%-95%). RVVE to prevent hospital admission due to rotavirus AGE was 94.7%(83-98.4%). Once a child has an AGE, being vaccinated reduced the risk of admission by 44% with a number needed to vaccinate of 4 (p values were non significant). Conclusions: Rotavirus vaccines have also showed an outstanding effectiveness in Spain despite lowmedium coverage rates yet.

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