Multicomponent meningococcal B vaccine (recombinant, adsorbed)

(Bexsero®)

Multicomponent meningococcal B vaccine (recombinant, adsorbed)

Drug updated on 9/5/2024

Dosage FormInjection (intramuscular; 0.5 mL [50 mcg])
Drug ClassVaccines
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
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  • 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 TitleYearSource
Bexsero (multicomponent meningococcal B vaccine [recombinant, adsorbed]) Prescribing Information.2023GlaxoSmithKline Inc., Mississauga, Ontario

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines