title: 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 RIX4414 (N=5,359) or placebo (N=5,349). 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.
authors.affiliation: Department of Paediatrics, KK Women's and Children's Hospital, 100 Bukit, Timah Road, Singapore 229899, Singapore. Phua.Kong.Boo@kkh.com.sg
authors.forename: K B
authors.initials: KB
authors.lastname: Phua
authors.forename: F S
authors.initials: FS
authors.lastname: Lim
authors.forename: Y L
authors.initials: YL
authors.lastname: Lau
authors.forename: E A S
authors.initials: EA
authors.lastname: Nelson
authors.forename: L M
authors.initials: LM
authors.lastname: Huang
authors.forename: S H
authors.initials: SH
authors.lastname: Quak
authors.forename: B W
authors.initials: BW
authors.lastname: Lee
authors.forename: Y L
authors.initials: YL
authors.lastname: Teoh
authors.forename: H
authors.initials: H
authors.lastname: Tang
authors.forename: I
authors.initials: I
authors.lastname: Boudville
authors.forename: L C
authors.initials: LC
authors.lastname: Oostvogels
authors.forename: P V
authors.initials: PV
authors.lastname: Suryakiran
authors.forename: I V
authors.initials: IV
authors.lastname: Smolenov
authors.forename: H H
authors.initials: HH
authors.lastname: Han
authors.forename: H L
authors.initials: HL
authors.lastname: Bock
mesh_terms: D002675:Child, Preschool; D004311:Double-Blind Method; D005759:Gastroenteritis / Q000517:prevention & control* / Q000821:virology; D006801:Humans; D007223:Infant; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage*; D014613:Vaccines, Attenuated / Q000008:administration & dosage
chemical_list: C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated