title: Rotavirus vaccine RIX4414 efficacy sustained during the third year of life: a randomized clinical trial in an Asian population.
abstract: RIX4414 (Rotarix™), has shown high efficacy during the first 2-years of life. A 2-year randomized, double-blind, placebo-controlled trial in Singapore, Hong Kong, and Taiwan was extended for another year. Infants (6-17 weeks) received 2-doses (1-2 months apart) of RIX4414 (n=5359) or placebo (n=5349). During the third-year follow-up, 4359 (RIX4414) and 4328 (placebo) infants were monitored. 64 (1.2%) and 2 (0.04%) infants in the placebo and RIX4414 groups, respectively, reported severe rotavirus-gastroenteritis (RVGE), resulting in a vaccine efficacy of 96.9% (95% CI [88.3-99.6]). Efficacy was 100% (67.5-100) in the third-year. RIX4414 was efficacious against G1 (100.0% [84.8-100]) and pooled non-G1 RV types (94.9% [80.2-99.4]). This study shows that the vaccine is highly efficacious, regardless of circulating RV-types, up to the first 3 years of life in affluent Asian urban populations.
authors.affiliation: Department of Paediatrics, KK Women's and Children's Hospital, Singapore 229899, Singapore. Phua.Kong.Boo@kkh.com.sg
authors.forename: Kong Boo
authors.initials: KB
authors.lastname: Phua
authors.forename: Fong Seng
authors.initials: FS
authors.lastname: Lim
authors.forename: Yu Lung
authors.initials: YL
authors.lastname: Lau
authors.forename: Edmund Anthony Severn
authors.initials: EA
authors.lastname: Nelson
authors.forename: Li Min
authors.initials: LM
authors.lastname: Huang
authors.forename: Seng Hock
authors.initials: SH
authors.lastname: Quak
authors.forename: Bee Wah
authors.initials: BW
authors.lastname: Lee
authors.forename: Leen Jan
authors.initials: LJ
authors.lastname: van Doorn
authors.forename: Yee Leong
authors.initials: YL
authors.lastname: Teoh
authors.forename: Haiwen
authors.initials: H
authors.lastname: Tang
authors.forename: P V
authors.initials: PV
authors.lastname: Suryakiran
authors.forename: Igor V
authors.initials: IV
authors.lastname: Smolenov
authors.forename: Hans L
authors.initials: HL
authors.lastname: Bock
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
mesh_terms: D044466:Asian People; D002675:Child, Preschool; D004311:Double-Blind Method; D005260:Female; D005759:Gastroenteritis / Q000517:prevention & control* / Q000821:virology; D006723:Hong Kong; D006801:Humans; D007223:Infant; D008297:Male; D012400:Rotavirus Infections / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage*; D012846:Singapore; D013624:Taiwan; D014613:Vaccines, Attenuated / Q000008:administration & dosage
chemical_list: C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated