title: Immunogenicity and reactogenicity of the human rotavirus vaccine, RIX4414 oral suspension, when co-administered with routine childhood vaccines in Chinese infants.
abstract: This study evaluated the immunogenicity of the human rotavirus (RV) vaccine (RIX4414) when co-administered with routine childhood vaccines in Chinese infants (NCT01171963). Healthy infants aged 6-16 weeks received 2 doses of either RIX4414 or placebo according to a 0, 1-month schedule. Infants received routine diphtheria-tetanus-acellular pertussis (DTPa) and oral poliovirus (OPV) vaccines either separately from or concomitantly with RIX4414/placebo (separate and co-administration cohorts, respectively). Anti-RV IgA seroconversion rates (one month post-dose-2) and seropositivity rates (at one year of age) were measured using ELISA. Immune responses against the DTPa and OPV antigens were measured one month post-DTPa dose-3 in the co-administration cohort. Solicited local and general symptoms were recorded for 8-days post-vaccination (total cohort). The according-to-protocol immunogenicity population included 511 infants in the separate cohort and 275 in the co-administration cohort. One month post-RIX4414 dose-2, anti-RV IgA seroconversion rates were 74.7% (95% confidence interval [CI]: 68.9-79.9) and 64.2% (95% CI: 55.4-72.3) in the separate and co-administration cohorts; seropositivity rates at one year of age were 71.5% (95% CI: 65.5-77.1) and 50.0% (95% CI: 40.9-59.1), respectively. One month post-DTPa dose-3, all infants in the co-administration cohort were seroprotected against diphtheria and tetanus, and seropositive for pertussis toxoid, pertactin and filamentous haemaglutinin. Two months post-OPV dose-3, seroprotection rates against anti-poliovirus types 1, 2 and 3 were >99% in the co-administration cohort. Reactogenicity profiles were similar in both cohorts. RIX4414 was immunogenic and well-tolerated in Chinese infants and did not appear to interfere with the immunogenicity and reactogenicity of co-administered routine childhood vaccines.
authors.affiliation: a Guangxi Center for Disease Prevention and Control , Guangxi Autonomous Region , China.
authors.forename: Rong-Cheng
authors.initials: RC
authors.lastname: Li
authors.affiliation: a Guangxi Center for Disease Prevention and Control , Guangxi Autonomous Region , China.
authors.forename: Teng
authors.initials: T
authors.lastname: Huang
authors.affiliation: a Guangxi Center for Disease Prevention and Control , Guangxi Autonomous Region , China.
authors.forename: Yanping
authors.initials: Y
authors.lastname: Li
authors.affiliation: b Liucheng County Center for Disease Prevention and Control , Guangxi Autonomous Region , China.
authors.forename: Lao-Hong
authors.initials: LH
authors.lastname: Wang
authors.affiliation: c Liujiang County Center for Disease Prevention and Control , Guangxi Autonomous Region , China.
authors.forename: Junhui
authors.initials: J
authors.lastname: Tao
authors.affiliation: d Luzhai County Center for Disease Prevention and Control , Guangxi Autonomous Region , China.
authors.forename: Botao
authors.initials: B
authors.lastname: Fu
authors.affiliation: e Jinchengjiang region Center for Disease Prevention and Control , Guangxi Autonomous Region , China.
authors.forename: Guoai
authors.initials: G
authors.lastname: Si
authors.affiliation: a Guangxi Center for Disease Prevention and Control , Guangxi Autonomous Region , China.
authors.forename: Yi
authors.initials: Y
authors.lastname: Nong
authors.affiliation: a Guangxi Center for Disease Prevention and Control , Guangxi Autonomous Region , China.
authors.forename: Zhaojun
authors.initials: Z
authors.lastname: Mo
authors.affiliation: f GSK Vaccines , Beijing , China.
authors.forename: XueYan
authors.initials: X
authors.lastname: Liao
authors.affiliation: f GSK Vaccines , Beijing , China.
authors.forename: Ivy
authors.initials: I
authors.lastname: Luan
authors.affiliation: f GSK Vaccines , Beijing , China.
authors.forename: Haiwen
authors.initials: H
authors.lastname: Tang
authors.affiliation: g GSK Pharmaceuticals Ltd. , Bangalore , India.
authors.forename: Niraj
authors.initials: N
authors.lastname: Rathi
authors.affiliation: g GSK Pharmaceuticals Ltd. , Bangalore , India.
authors.forename: Naveen
authors.initials: N
authors.lastname: Karkada
authors.affiliation: h GSK Vaccines , Philadelphia , PA , USA.
authors.forename: Htay Htay
authors.initials: HH
authors.lastname: Han
mesh_terms: D000284:Administration, Oral; D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D002681:China; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007070:Immunoglobulin A / Q000097:blood; D007223:Infant; D008297:Male; D010919:Placebos / Q000008:administration & dosage; D023321:Poliovirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D022243:Rotavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014613:Vaccines, Attenuated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D007070:Immunoglobulin A; D010919:Placebos; D023321:Poliovirus Vaccines; C492457:RIX4414 vaccine; D022243:Rotavirus Vaccines; D014613:Vaccines, Attenuated
keywords: China; DTPa; OPV; RIX4414; immunogenicity; reactogenicity; rotavirus; routine childhood vaccines