A Phase 3 study to assess the safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) co-administered with routine pediatric vaccines in healthy infants in the USA and Puerto Rico.

ABSTRACT: A quadrivalent meningococcal tetanus toxoid-conjugate vaccine, MenACYW-TT, has been developed to provide protection against invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W. This Phase 3 study (NCT03537508; April 25, 2018, to September 22, 2023) evaluated the immunogenicity and safety of MenACYW-TT, compared with a licensed quadrivalent meningococcal oligosaccharide diphtheria CRM₁₉₇-conjugate vaccine (MenACWY-CRM), in healthy infants ≥6 weeks of age when administered concomitantly with routine pediatric vaccines in a four-dose series (3 + 1 schedule). Functional antibodies against each meningococcal serogroup were measured by serum bactericidal antibody assay using human complement (hSBA). Non-inferiority was demonstrated for the

SUBMITTER: Campbell JD 

PROVIDER: S-EPMC12688245 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature