Key Takeaways & Executive Findings
- •• MenB vaccine reduced IMD incidence by 78.3% in children aged 6 months to 5 years. • Vaccine effectiveness was consistent across age subgroups and geographic regions. • No significant increase in adverse events was observed in the MenB group. • 95% of vaccinated children achieved protective antibody titers after the primary series.
Abstract
Background: Invasive meningococcal disease (IMD) is a severe bacterial infection with high morbidity and mortality, particularly in children. The meningococcal group B vaccine (MenB) has been developed to prevent IMD caused by Neisseria meningitidis serogroup B. However, real-world evidence on its effectiveness in diverse pediatric populations remains limited. Methods: We conducted a multicenter prospective cohort study across multiple centers in China from January 2020 to December 2022. A total of 1,200 children aged 6 months to 5 years were enrolled, with 600 receiving MenB vaccine (4CMenB) and 600 receiving a control vaccine (hepatitis A). Participants were followed for 24 months. The primary outcome was the incidence of IMD, confirmed by culture or PCR. Secondary outcomes included adverse events and immunogenicity (serum bactericidal antibody titers). Results: The incidence of IMD was significantly lower in the MenB group (0.5 per 100,000 person-years) compared to the control group (2.3 per 100,000 person-years), with a vaccine effectiveness of 78.3% (95% CI: 55.2-89.4%). No significant differences in adverse events were observed between groups. Immunogenicity analysis showed that 95% of MenB recipients achieved protective antibody titers (≥1:4) after the primary series, and titers remained elevated at 24 months. Subgroup analyses indicated consistent effectiveness across age groups and geographic regions. Conclusions: The MenB vaccine demonstrated high effectiveness in reducing IMD incidence in children, with a favorable safety profile. These findings support the inclusion of MenB vaccination in routine pediatric immunization programs to reduce the burden of IMD.
1. Introduction
Invasive meningococcal disease (IMD) is a severe bacterial infection caused by Neisseria meningitidis, leading to meningitis and septicemia with high case-fatality rates, especially in young children. Among the six main serogroups (A, B, C, W, X, and Y), serogroup B has emerged as a predominant cause of IMD in many regions, including China. The development of effective vaccines against serogroup B has been challenging due to the poor immunogenicity of its capsular polysaccharide and its molecular mimicry with human neural antigens. However, the introduction of outer membrane vesicle (OMV) vaccines and, more recently, factor H binding protein (fHbp)-based vaccines such as 4CMenB (Bexsero) has provided new tools for prevention.
Despite the availability of MenB vaccines, real-world evidence on their effectiveness in diverse pediatric populations is still accumulating. Previous clinical trials have demonstrated immunogenicity and short-term safety, but post-licensure studies are needed to confirm effectiveness against IMD and to monitor long-term safety. This multicenter prospective cohort study was conducted to evaluate the effectiveness of the 4CMenB vaccine in reducing IMD incidence in children aged 6 months to 5 years in China, and to assess its safety and immunogenicity over a 24-month follow-up period.
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ZHANG Wei, LI Ming, WANG Fang, et al. (2025). Efficacy of Meningococcal Group B Vaccine in Reducing Invasive Meningococcal Disease in Children: A Multicenter Prospective Cohort Study. Chinese Journal of New Drugs. https://doi.org/cast_zgxyzz_1236731780393390427
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Frequently Asked Questions
What is the effectiveness of the MenB vaccine in children?
The MenB vaccine (4CMenB) showed 78.3% effectiveness in reducing invasive meningococcal disease (IMD) in children aged 6 months to 5 years over a 24-month follow-up.
What are the common side effects of the MenB vaccine?
The study found no significant increase in adverse events in the MenB group compared to the control group. Common side effects were mild and included injection site reactions and transient fever.
How long does immunity from the MenB vaccine last?
In this study, 95% of vaccinated children achieved protective antibody titers after the primary series, and titers remained elevated at 24 months, suggesting durable immunity.
Is the MenB vaccine recommended for all children?
Based on the high effectiveness and safety profile observed, the study supports the inclusion of MenB vaccination in routine pediatric immunization programs to reduce the burden of IMD.
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