title: Safety and immunogenocity of a novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C-tetanus-toxoid conjugate vaccine in healthy Chinese children aged 6 months to 5 years old.
abstract: A novel combined Haemophilus influenzae type b-Neisseria meningitidis serogroups A and C-tetanus-toxoid conjugate vaccine (Hib-MenAC vaccine) has been developed to protect children against diseases caused by Hib, MenA, and MenC. This study investigated the safety and immunogenicity of the Hib-MenAC vaccine administered in 2-dose series to children aged 6-23 months and in a single dose to children aged 2-5 y. A randomized, positive-controlled, non-inferiority clinical trial was conducted for 1200 healthy participants in each age group. Within each age group, participants were randomly allocated to the Hib-MenAC group or the control group at a ratio of 1:1. Adverse reactions were recorded within 28 d after each dose. Blood samples were obtained to assess immunogenicity on day 0 and at 28 d after a complete vaccination course. For the investigational vaccine, the incidence of total adverse reactions in vaccinees aged 6-23 months was 46.8% and that in vaccinees aged 2-5 y was 29.8%. Most adverse reactions were mild or moderate. One non-fatal serious adverse event occurred in the Hib-MenAC group, but was unrelated to vaccination. The seroconversion rate to the 3 components reached 94.0%, and the proportion of vaccinees with rSBA titers ≥ 1:8 and PRP ≥ 0.15 g/mL reached 97.0% in both age groups. The safety and immunogenicity of the Hib-MenAC vaccine were non-inferior when compared to the licensed vaccines. It was concluded that the novel vaccine would be expected to protect children against all of the targeted diseases.
authors.affiliation: a Jiangsu Province Center for Disease Control and Prevention ; Nanjing , Jiangsu , China.
authors.forename: Jian-li
authors.initials: JL
authors.lastname: Hu
authors.forename: Hong
authors.initials: H
authors.lastname: Tao
authors.forename: Jing-xin
authors.initials: JX
authors.lastname: Li
authors.forename: Wei-ming
authors.initials: WM
authors.lastname: Dai
authors.forename: Bin
authors.initials: B
authors.lastname: Song
authors.forename: Jin-fang
authors.initials: JF
authors.lastname: Sun
authors.forename: Pei
authors.initials: P
authors.lastname: Liu
authors.forename: Jie
authors.initials: J
authors.lastname: Tang
authors.forename: Wen-yu
authors.initials: WY
authors.lastname: Liu
authors.forename: Shi-yuan
authors.initials: SY
authors.lastname: Wang
authors.forename: Feng-cai
authors.initials: FC
authors.lastname: Zhu
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D002675:Child, Preschool; D002681:China; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006192:Haemophilus Infections / Q000517:prevention & control; D018073:Haemophilus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D019741:Haemophilus influenzae type b / Q000276:immunology*; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control; 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*; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000276:immunology; 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; D013745:Tetanus Toxoid; D017778:Vaccines, Combined; D018074:Vaccines, Conjugate
keywords: ATP, according to protocol; CI, confidence interval; EPI, Expanded Program on Immunization; GMCs, geometric mean concentrations; GMTs, geometric mean titers; Haemophilus influenzae type b; Hib, Haemophilus influenzae; Hib-MenAC vaccine, combined Haemophilus influenzae; MenA, Neisseria meningitidis serogroup A; MenC, Neisseria meningitidis serogroup C; Neisseria meningitidis; PRP, polyribosylribitol phosphate; RD, rate difference; SAEs, serious adverse events; children; china; conjugate vaccine; rSBA, a serum bactericidal assay using baby rabbit complement; type b; type b–Neisseria meningitidis serogroups A and C-tetanus-toxoid conjugate vaccine
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