Efficacy of human rotavirus vaccine against rotavirus gastroenteritis during the first 2 years of life in European infants: randomised, double-blind controlled study
| Autor: | Robert Cohen, Alain Bouckenooghe, Aino Karvonen, Timo Vesikari, H.H. Han, Roman Prymula, Volker Schuster, J. C. Tejedor, Silvia Damaso, F Meurice |
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| Rok vydání: | 2007 |
| Předmět: |
education.field_of_study
Pediatrics medicine.medical_specialty biology business.industry Population Reoviridae General Medicine medicine.disease_cause Vaccine efficacy Placebo biology.organism_classification Rotavirus vaccine law.invention Vaccination Randomized controlled trial law Rotavirus medicine education business |
| Zdroj: | The Lancet. 370:1757-1763 |
| ISSN: | 0140-6736 0014-0686 |
| Popis: | Summary Background We aimed to assess the efficacy of the oral live attenuated human rotavirus vaccine Rotarix (RIX4414) for prevention of rotavirus gastroenteritis in European infants during their first 2 years of life. Methods 3994 study participants were enrolled from six countries and were randomly assigned two oral doses of either RIX4414 (n=2646) or placebo (n=1348), which were coadministered with the first two doses of specific childhood vaccinations. Follow-up for gastroenteritis episodes was undertaken from 2 weeks post-dose two through the two consecutive rotavirus seasons following vaccinations (combined efficacy follow-up period; mean duration 17 months [SD 1·6]). Our primary endpoint was vaccine efficacy against rotavirus gastroenteritis of any severity during the first efficacy follow-up period (2 weeks post-dose two to the end of the first rotavirus season). Stool specimens obtained during gastroenteritis episodes were tested for rotavirus by ELISA and typed by RT-PCR. Episodes scoring 11 or greater on the 20-point Vesikari scale were classified as severe. Analysis was according to protocol. This study is registered with ClinicalTrials.gov, number NCT00140686 (eTrack102247). Findings 120 infants were excluded from the according-to-protocol analysis. During the first efficacy follow-up period (mean duration 5·7 months [SD 1·2]), 24 of 2572 infants allocated RIX4414 versus 94 of 1302 given placebo had rotavirus gastroenteritis episodes of any severity, resulting in a vaccine efficacy of 87·1% (95% CI 79·6–92·1; p Interpretation In a European setting, two doses of RIX4414 coadministered with childhood vaccines provided high protection against any and severe rotavirus gastroenteritis, with an overall reduction of admissions for gastroenteritis over two consecutive rotavirus epidemic seasons. |
| Databáze: | OpenAIRE |
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