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Safety and immunogenicity of concomitant quadrivalent meningococcus ACYW-TT and meningococcus group B vaccines

Monica A McArthur1, Adam Finn2, Lawrence Barnes3

  • 1Global Clinical Development Strategy, Sanofi, Swiftwater, PA, USA. monica.mcarthur@sanofi.com.

NPJ Vaccines
|July 1, 2026
PubMed

Insights

This study found that infants receiving both the quadrivalent meningococcal ACWY conjugated vaccine (MenACYW-TT) and the meningococcus group B vaccine (4CMenB) showed high protection rates. Both vaccine schedules were safe and effective for infant meningococcal disease prevention.

Area of Science:

  • Vaccinology
  • Pediatric Infectious Diseases
  • Immunology

Background:

  • Infants are highly susceptible to invasive meningococcal disease, a serious bacterial infection.
  • Effective vaccination strategies are crucial for protecting vulnerable infant populations.
  • Quadrivalent meningococcal ACWY conjugated vaccine (MenACYW-TT) and four-component meningococcus group B vaccine (4CMenB) are key tools.

Purpose of the Study:

  • To evaluate the immunogenicity and safety of different infant vaccination schedules combining MenACYW-TT and 4CMenB.
  • To assess non-inferiority of seroprotection rates between two combined vaccine schedules.
  • To investigate potential cross-reactivity and overall safety profiles.

Main Methods:

  • Open-label, phase III randomized study involving three infant vaccination groups.
  • Group 1: MenACYW-TT at 3 and 12-13 months, 4CMenB at 2, 4, and 12-13 months.
  • Group 2: MenACYW-TT at 3 and 12-13 months, 4CMenB at 2 and 4 months. Group 3: 4CMenB at 2, 4, and 12-13 months.

Main Results:

  • Non-inferiority of seroprotection (≥99%) against meningococcal serogroups A, C, W, and Y was demonstrated between Group 1 and Group 2 after the second MenACYW-TT dose.
  • Group 3 showed increased hSBA titres against serogroups A and C after the third 4CMenB dose, indicating cross-reactivity.
  • Reactogenicity was consistent with known vaccine profiles; one anaphylaxis case related to MenACYW-TT resolved without sequelae. No new safety concerns emerged.

Conclusions:

  • Combined infant vaccination schedules with MenACYW-TT and 4CMenB achieve high seroprotection rates against target meningococcal serogroups.
  • The evaluated schedules are safe and well-tolerated in infants.
  • The study supports the use of MenACYW-TT and 4CMenB in routine infant immunization programs for comprehensive meningococcal protection.

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