https://scholars.lib.ntu.edu.tw/handle/123456789/566531
Title: | Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: Randomised, double-blind, controlled study | Authors: | Phua K.B. Lim F.S. Lau Y.L. Nelson E.A.S. LI-MIN HUANG 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. |
Keywords: | Diarrhoea; Efficacy; Gastroenteritis; Human rotavirus vaccine; Rotavirus | Issue Date: | 2009 | Journal Volume: | 27 | Journal Issue: | 43 | Start page/Pages: | 5936-5941 | Source: | Vaccine | 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. ? 2009 Elsevier Ltd. All rights reserved. |
URI: | https://www.scopus.com/inward/record.uri?eid=2-s2.0-70349431081&doi=10.1016%2fj.vaccine.2009.07.098&partnerID=40&md5=785e4c6b08561cbb0d3233b780db2efd https://scholars.lib.ntu.edu.tw/handle/123456789/566531 |
ISSN: | 0264-410X | DOI: | 10.1016/j.vaccine.2009.07.098 | SDG/Keyword: | live vaccine; placebo; Rotavirus vaccine; article; Asian; clinical trial; controlled clinical trial; controlled study; disease severity; double blind procedure; drug efficacy; drug fatality; drug safety; female; gastroenteritis; human; immunity; infancy; infant; intussusception; male; multicenter study; population; priority journal; public health; randomized controlled trial; virus infection; Child, Preschool; Double-Blind Method; Gastroenteritis; Humans; Infant; Rotavirus Infections; Rotavirus Vaccines; Vaccines, Attenuated |
Appears in Collections: | 醫學系 |
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