Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: Randomised, double-blind, controlled study

Abstract This study evaluates the safety and efficacy against severe rotavirus gastroenteritis of the oral live attenuated human rotavirus vaccine RIX4414 ( Rotarix ™) during the first 2 years of life in Asian infants from high-income countries. Healthy infants were enrolled to receive 2 doses of RI...

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Veröffentlicht in:Vaccine 2009-10, Vol.27 (43), p.5936-5941
Hauptverfasser: Phua, K.B, Lim, F.S, Lau, Y.L, Nelson, E.A.S, Huang, L.M, Quak, S.H, Lee, B.W, Teoh, Y.L, Tang, H, Boudville, I, Oostvogels, L.C, Suryakiran, P.V, Smolenov, I.V, Han, H.H, Bock, H.L
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Sprache:eng
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Zusammenfassung:Abstract This study evaluates the safety and efficacy against severe rotavirus gastroenteritis of the oral live attenuated human rotavirus vaccine RIX4414 ( Rotarix ™) during the first 2 years of life in Asian infants from high-income countries. Healthy infants were enrolled to receive 2 doses of RIX4414 ( N = 5359) or placebo ( N = 5349). From 2 weeks post-dose 2 to 2 years of age, vaccine efficacy was 96.1% (95%CI:85.1%; 99.5%) against severe rotavirus gastroenteritis, 100% (95%CI:80.8%; 100%) against wild-type G1P[8] and 93.6% (95%CI:74.7%; 99.3%) against circulating non-G1 rotavirus types. No intussusception cases were reported within 31 days post-vaccination. RIX4414 shows a good safety profile and offers high protection during the first 2 years of life with potentially significant public health impact in this population.
ISSN:0264-410X
1873-2518
DOI:10.1016/j.vaccine.2009.07.098