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Introduction <p>The immunogenicity and safety of MenACYW-TT (MenQuadfi<sup>®</sup>) were compared to another quadrivalent meningococcal conjugate vaccine, MCV4-TT (Nimenrix<sup>®</sup>), when administered in infants alongside routine childhood vaccines in Europe.</p> Methods <p>One set of healthy infants was randomized 1:1 to receive MenACYW-TT (group 1; <i>n</i> = 714) or MCV4-TT (group 2; <i>n</i> = 726) at age 2, 4, and 12–18&#xa0;months (2 + 1 regimen) concomitantly with routine vaccines (including 10-valent pneumococcal conjugate vaccine). Another set was randomized 1:1 to receive MenACYW-TT in a 2 + 1 regimen (group 3; <i>n</i> = 112) or a 3 + 1 regimen at age 2, 4, 6, and 12–18&#xa0;months (group 4; <i>n</i> = 108) concomitantly with routine vaccines (including 13-valent pneumococcal conjugate vaccine). Immune responses against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority of MenACYW-TT versus MCV4-TT was based on hSBA geometric mean titers (GMTs) 30&#xa0;days post-booster (dose 3; primary endpoint) and rates of seroprotection 30&#xa0;days post-dose 2 (secondary endpoint) against all vaccine meningococcal serogroups. Immune responses to co-administered vaccines and safety were also assessed. Post hoc, non-inferiority of MenACYW-TT was also assessed based on seroresponse rates 30&#xa0;days post-booster.</p> Results <p>Non-inferiority of MenACYW-TT versus MCV4-TT, based on GMTs post-booster, was demonstrated for serogroups C, W, and Y but not for A. GMTs against serogroups C, W, and Y were 1.5- to 4.5-fold higher with MenACYW-TT than MCV4-TT; those against serogroup A were marginally lower. Antibody responses in groups 3 and 4 against all serogroups were similar to group 1. Non-inferiority of MenACYW-TT based on seroresponse rates post-booster against all serogroups was demonstrated post hoc. No interference with concomitant routine vaccines nor safety concerns were identified.</p> Conclusions <p>Consideration of all immunogenicity and safety data generated in this study supports the incorporation of MenACYW-TT into the routine childhood vaccination schedule as a 2 + 1 regimen starting at age 6&#xa0;weeks.</p> ClinicalTrials.gov identifier <p>NCT03547271.</p>

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Immunogenicity and Safety of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW-TT) Administered with Routine Pediatric Vaccines: A European Randomized Controlled Trial

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  • 出版模式：

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  • 发表日期：

    2025年7月15日

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  • Federico Martinon-Torres,
  • Miia M. Virta,
  • Susanna Koski,
  • Ignacio Salamanca de la Cueva,
  • Henryk T. Szymanski,
  • Samantha Bosis,
  • Anca C. Drăgănescu,
  • Sven-Arne Silfverdal,
  • Betzana Zambrano,
  • Mandeep S. Dhingra,
  • Siham B’Chir,
  • Olga Syrkina,
  • Olga Lyabis,
  • Gustavo A. Vasquez,
  • Christine Rehm

摘要

Introduction

The immunogenicity and safety of MenACYW-TT (MenQuadfi®) were compared to another quadrivalent meningococcal conjugate vaccine, MCV4-TT (Nimenrix®), when administered in infants alongside routine childhood vaccines in Europe.

Methods

One set of healthy infants was randomized 1:1 to receive MenACYW-TT (group 1; n = 714) or MCV4-TT (group 2; n = 726) at age 2, 4, and 12–18 months (2 + 1 regimen) concomitantly with routine vaccines (including 10-valent pneumococcal conjugate vaccine). Another set was randomized 1:1 to receive MenACYW-TT in a 2 + 1 regimen (group 3; n = 112) or a 3 + 1 regimen at age 2, 4, 6, and 12–18 months (group 4; n = 108) concomitantly with routine vaccines (including 13-valent pneumococcal conjugate vaccine). Immune responses against meningococcal serogroups A, C, W, and Y were measured by serum bactericidal assay using human complement (hSBA). Non-inferiority of MenACYW-TT versus MCV4-TT was based on hSBA geometric mean titers (GMTs) 30 days post-booster (dose 3; primary endpoint) and rates of seroprotection 30 days post-dose 2 (secondary endpoint) against all vaccine meningococcal serogroups. Immune responses to co-administered vaccines and safety were also assessed. Post hoc, non-inferiority of MenACYW-TT was also assessed based on seroresponse rates 30 days post-booster.

Results

Non-inferiority of MenACYW-TT versus MCV4-TT, based on GMTs post-booster, was demonstrated for serogroups C, W, and Y but not for A. GMTs against serogroups C, W, and Y were 1.5- to 4.5-fold higher with MenACYW-TT than MCV4-TT; those against serogroup A were marginally lower. Antibody responses in groups 3 and 4 against all serogroups were similar to group 1. Non-inferiority of MenACYW-TT based on seroresponse rates post-booster against all serogroups was demonstrated post hoc. No interference with concomitant routine vaccines nor safety concerns were identified.

Conclusions

Consideration of all immunogenicity and safety data generated in this study supports the incorporation of MenACYW-TT into the routine childhood vaccination schedule as a 2 + 1 regimen starting at age 6 weeks.

ClinicalTrials.gov identifier

NCT03547271.