Drug updated on 4/24/2024
| Dosage Form | Injection (intramuscular; 0.5 mL [50 mcg]) |
| Drug Class | Vaccines |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. Bexsero is approved for use in individuals aged 10 through 25 years.
Summary
- Multicomponent meningococcal B vaccine (recombinant, adsorbed) (Bexsero) is indicated for active immunization of individuals from 2 months through 25 years old against invasive disease caused by Neisseria meningitidis serogroup B strains.
- The analysis is based on a systematic review/meta-analysis regarding the safety and effectiveness of Bexsero.
- Bexsero has an acceptable short-term safety profile with an incidence rate of potentially vaccine-related acute serious adverse events recorded at 5.74 per 1000 individuals. Although this rate is higher compared to routine vaccines, it indicates that Bexsero is relatively safe, albeit with slightly more risk.
- High rates of seroconversion were observed after the primary vaccination course, indicating a strong initial immune response; however, long-term immunogenicity showed some decline, especially against certain strains, without booster dose administration.
- Efficacy in inducing seroconversion varies between children and adolescents; adequate long-term immunogenicity was observed in adolescents for three strains, while only two strains showed adequacy before introducing a booster in children.
- A booster dose significantly increased the proportion achieving seroconversion across all strains, reaching above 93%, underlining its importance for maintaining prolonged protection, particularly among younger children.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Bexsero (multicomponent meningococcal B vaccine [recombinant, adsorbed]) Prescribing Information. | 2023 | GlaxoSmithKline Inc., Mississauga, Ontario |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Immunogenicity and safety of the multicomponent meningococcal B vaccine (4CMenB) in children and adolescents: A systematic review and meta-analysis. | 2018 | The Lancet Infectious Diseases |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Real-world implementation of 4-component meningococcal serogroup B vaccine (4CMenB): Implications for clinical practices. | 2022 | Expert Review of Vaccines |