title: The immunogenicity and safety of a Hib-MenAC vaccine: a non-inferiority randomized, observer-blind trial in infants aged 3-5 months.
abstract: BACKGROUND
  The objective of this study was to evaluate the immunogenicity and safety of the novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroup A and C-tetanus toxoid conjugate vaccine (Hib-MenAC).
  
  
  METHODS
  We conducted a non-inferiority, randomized, observer-blind, positive control clinical trial in 900 healthy infants aged between 3-5 months in Funing County, Jiangsu Province, China. Participants were randomly allocated, in a ratio of 2:1 (block = 6), to receive experimental combined Hib-MenAC vaccines co-administrated with placebo or the co-administration of licensed Hib vaccine and MenAC vaccine, according to a three-dose immunization schedule. The seroconversion of antibody titer against meningococcal serogroups A, C and Hib was the primary endpoint.
  
  
  RESULTS
  The experimental vaccines was non-inferior to the licensed two control vaccines. Participants receiving experimental Hib-MenAC vaccines showed a seroconversion rate of 99.0%, 96.1% and 97.7% for rSBA-MenA, rSBA-MenC and anti-PRP antibodies, respectively. The Hib-MenAC vaccine did not result in an increase in adverse reaction, and no serious adverse event was judged to be related to the vaccination.
  
  
  CONCLUSIONS
  The novel combined Hib-MenAC conjugate vaccine was safe and highly immunogenic in infants aged between 3 to 5 months.
authors.affiliation: a School of Public Health , Southeast University , Nanjing , PR China.
authors.forename: Yu-Xiao
authors.initials: YX
authors.lastname: Wang
authors.affiliation: b Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.
authors.forename: Hong
authors.initials: H
authors.lastname: Tao
authors.affiliation: b Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.
authors.forename: Jian-Li
authors.initials: JL
authors.lastname: Hu
authors.affiliation: b Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.
authors.forename: Jing-Xin
authors.initials: JX
authors.lastname: Li
authors.affiliation: b Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.
authors.forename: Wei-Ming
authors.initials: WM
authors.lastname: Dai
authors.affiliation: a School of Public Health , Southeast University , Nanjing , PR China.
authors.forename: Jin-Fang
authors.initials: JF
authors.lastname: Sun
authors.affiliation: a School of Public Health , Southeast University , Nanjing , PR China.
authors.forename: Pei
authors.initials: P
authors.lastname: Liu
authors.affiliation: c Acute Infectious Disease Prevention Department , Funing County Center for Disease Control and Prevention , Yancheng , PR China.
authors.forename: Jie
authors.initials: J
authors.lastname: Tang
authors.affiliation: c Acute Infectious Disease Prevention Department , Funing County Center for Disease Control and Prevention , Yancheng , PR China.
authors.forename: Wen-Yu
authors.initials: WY
authors.lastname: Liu
authors.affiliation: a School of Public Health , Southeast University , Nanjing , PR China.|b Vaccine Clinical Evaluation Department , Jiangsu Provincial Center for Disease Control and Prevention , Nanjing , PR China.
authors.forename: Feng-Cai
authors.initials: FC
authors.lastname: Zhu
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D002681:China; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology; D006801:Humans; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D038381:Neisseria meningitidis, Serogroup A / Q000276:immunology; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology; D010919:Placebos / Q000008:administration & dosage; D016037:Single-Blind Method; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D016896:Treatment Outcome; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D018073:Haemophilus Vaccines; D022401:Meningococcal Vaccines; D010919:Placebos; D013745:Tetanus Toxoid; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate
keywords: Haemophilus influenza type b; Hib-MenAC vaccine; Immunogenicity; Neisseria meningitidis; Safety