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.
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.