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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.