Safety and efficacy of human rotavirus vaccine during the first 2 years of life in Asian infants: Randomised, double-blind, controlled study
Journal
Vaccine
Journal Volume
27
Journal Issue
43
Pages
5936-5941
Date Issued
2009
Author(s)
Phua K.B.
Lim F.S.
Lau Y.L.
Nelson E.A.S.
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.
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.
Subjects
Diarrhoea; Efficacy; Gastroenteritis; Human rotavirus vaccine; Rotavirus
SDGs
Other Subjects
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
Type
journal article