Drug updated on 9/5/2024
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.
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Summary
- Bexsero (multicomponent meningococcal B vaccine (recombinant, adsorbed) is 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.
- This summary is based on the review of one systematic review/meta-analysis. [1]
- Seroconversion Rates After Primary Immunization: Thirty days after the primary immunization course with the 4CMenB vaccine, seroconversion rates were high across multiple strains, including 92% (95% CI 89-95) for the 44/76-SL strain, 91% (95% CI 87-95) for the 5/99 strain, and 84% (95% CI 77-90) for the NZ98/254 strain.
- Persistence of Immunogenicity: Six months after the primary course, adolescents maintained seroconversion rates of ≥77% for the 5/99, 44/76-SL, and NZ98/254 strains, while children showed a decrease in seroconversion, particularly for the NZ98/254 strain (<35%) and the M10713 strain (<50%).
- Booster Dose Effectiveness: The booster dose resulted in seroconversion rates of ≥93% across all strains initially, with varying persistence six months later, including 95% for the 5/99 strain and a lower 35% for the NZ98/254 strain.
- Safety Profile: The 4CMenB vaccine demonstrated a higher incidence of potentially vaccine-related acute serious adverse events at 5.74 per 1000 individuals, compared to 1.2 per 1000 individuals for routine vaccines, indicating a higher risk profile for serious adverse events associated with 4CMenB.
- Subgroup Findings: Adolescents demonstrated higher persistence of immunogenicity six months after the primary 4CMenB vaccination course compared to children, who showed a significant drop in seroconversion rates, particularly for the M10713 and NZ98/254 strains. Children required a booster dose to maintain adequate long-term protection, especially for these strains, whereas adolescents had more stable immunogenicity over time.
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 |