title: Human rotavirus vaccine (RIX4414) efficacy in the first two years of life: a randomized, placebo-controlled trial in China.
abstract: Rotaviruses (RV) are a major cause of severe gastroenteritis (GE) in children aged<5 y. For the first time in China, we assessed the efficacy of two oral doses of the human rotavirus vaccine (RIX4414) in infants during the first two years of life (113808/NCT01171963). Healthy infants aged 6-16 weeks were randomized (1:1) to receive two oral doses of either the RIX4414 vaccine/placebo according to a 0, 1 month schedule. Vaccine efficacy (VE) against severe RVGE was assessed from two weeks post-Dose 2 up until the end of the second RV season and calculated with its 95% confidence intervals (CI). The primary efficacy objective was met if the lower limit of the 95% CI on VE was ≥10%. Unsolicited symptoms reported during the 31-d post-vaccination follow-up period and serious adverse events (SAEs) reported throughout the study were assessed. Of 3333 enrolled infants, 3148 were included in the according-to-protocol efficacy cohort. Over two consecutive RV seasons, fewer severe RVGE episodes were reported in the RIX4414 group (n=21) vs. the placebo group (n=75). VE against severe RVGE was 72% (95% CI: 54.1-83.6); the lower limit of the 95% CI on VE was >10%. The number of unsolicited symptoms and SAEs reported was similar between both groups. Thirteen deaths (RIX4414=6; placebo=7) occurred during the study. All SAEs and deaths in the RIX4414 group were considered unrelated to vaccination. Two oral doses of RIX4414 vaccine provided a substantial level of protection against severe RVGE in Chinese children during the first two years of life.
authors.affiliation: GuangXi Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
authors.forename: Rong-cheng
authors.initials: RC
authors.lastname: Li
authors.affiliation: GuangXi Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
authors.forename: Teng
authors.initials: T
authors.lastname: Huang
authors.affiliation: GuangXi Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
authors.forename: Yanping
authors.initials: Y
authors.lastname: Li
authors.affiliation: Liucheng County Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
authors.forename: Dong
authors.initials: D
authors.lastname: Luo
authors.affiliation: Liujiang County Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
authors.forename: Junhui
authors.initials: J
authors.lastname: Tao
authors.affiliation: Luzhai County Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
authors.forename: Botao
authors.initials: B
authors.lastname: Fu
authors.affiliation: Jinchengjiang region Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
authors.forename: Guoai
authors.initials: G
authors.lastname: Si
authors.affiliation: GuangXi Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Nong
authors.affiliation: GuangXi Center for Disease Prevention and Control; Guangxi, Autonomous Region PR China.
authors.forename: Zhaojun
authors.initials: Z
authors.lastname: Mo
authors.affiliation: GlaxoSmithKline Vaccines; Beijing, PR China.
authors.forename: XueYan
authors.initials: X
authors.lastname: Liao
authors.affiliation: GlaxoSmithKline Vaccines; Beijing, PR China.
authors.forename: Ivy
authors.initials: I
authors.lastname: Luan
authors.affiliation: GlaxoSmithKline Vaccines; Beijing, PR China.
authors.forename: Haiwen
authors.initials: H
authors.lastname: Tang
authors.affiliation: GlaxoSmithKline Pharmaceuticals Ltd.; Bangalore, India.
authors.forename: Niraj
authors.initials: N
authors.lastname: Rathi
authors.affiliation: GlaxoSmithKline Pharmaceuticals Ltd.; Bangalore, India.
authors.forename: Naveen
authors.initials: N
authors.lastname: Karkada
authors.affiliation: GlaxoSmithKline Vaccines; Philadelphia, PA USA.
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
mesh_terms: D000284:Administration, Oral; D002681:China / Q000453:epidemiology; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D005759:Gastroenteritis / Q000453:epidemiology / Q000517:prevention & control / Q000821:virology; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D010919:Placebos / Q000008:administration & dosage*; D012400:Rotavirus Infections / Q000453:epidemiology* / Q000517:prevention & control*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D016896:Treatment Outcome; D014611:Vaccination / Q000009:adverse effects* / Q000379:methods*
chemical_list: D010919:Placebos; D022243:Rotavirus Vaccines
keywords: China; Guangxi Province; RIX4414; efficacy; rotavirus gastroenteritis; safety