Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: Randomised, double-blind, controlled study
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AbstractThis study evaluates the safety and efficacy against severe rotavirus gastroenteritis of the oral live attenuated human rotavirus vaccine RIX4414 (Rotarix (TM)) 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. (C) 2009 Elsevier Ltd. All rights reserved.
All Author(s) ListPhua KB, Lim FS, Lau YL, Nelson EAS, Huang LM, Quak SH, Lee BW, Teoh YL, Tang H, Boudville I, Oostvogels LC, Suryakiran PV, Smolenov IV, Han HH, Bock HL
Journal nameVaccine
Year2009
Month10
Day9
Volume Number27
Issue Number43
PublisherElsevier
Pages5936 - 5941
ISSN0264-410X
eISSN1873-2518
LanguagesEnglish-United Kingdom
KeywordsDiarrhoea; Efficacy; Gastroenteritis; Human rotavirus vaccine; Rotavirus
Web of Science Subject CategoriesImmunology; IMMUNOLOGY; Medicine, Research & Experimental; MEDICINE, RESEARCH & EXPERIMENTAL; Research & Experimental Medicine

Last updated on 2020-02-04 at 01:32