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.

KEYWORDS:

• Haemophilus influenza type b
• Hib-MenAC vaccine
• Immunogenicity
• Neisseria meningitidis
• Safety

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties. The authors have provided the following clinical trial registration code: NCT01580033.

Supplemental data

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Additional information

Funding

This study was financially supported by the Royal (Wuxi) Biological Co., Ltd. The sponsor helped to design the trial but had no role in data collection, statistical analysis, interpretation or writing of the report.