Safety and immunogenicity of an investigational quadrivalent meningococcal CRM₁₉₇ conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America

Subject disposition flowchart.

MenACWY-CRM, quadrivalent meningococcal CRM₁₉₇ conjugate vaccine; MenACWY-D, quadrivalent meningococcal polysaccharide-protein conjugate vaccine; MPSV4, unconjugated quadrivalent meningococcal polysaccharide vaccine; SAE, serious adverse event.

^aInappropriate enrollments included: subject with a pacemaker; vaccination received 15 days before the day of enrollment; subject had doubts about previous meningococcal vaccination; subject was pregnant.

^bInappropriate enrollments included: subject had Sheehan's syndrome; subject planning to leave study area before the end of the study period; subject had doubts about previous meningococcal vaccination; subject did not want to use any contraception method; subject was pregnant; subject taking methotrexate due to rheumatoid arthritis; subject had supraventricular tachycardia.

^cUnrelated to the study vaccine.

Reverse cumulative distribution of hSBA titers in subjects (A)–(D) 19–55 years of age or (E)–(H) 56–65 years of age against meningococcal serogroups A, C, W-135, and Y, pre-vaccination and 1-month post-vaccination with MenACWY-CRM, MenACWY-D, or MPSV4.

hSBA, serum bactericidal activity using human complement; MenACWY-CRM, quadrivalent meningococcal CRM₁₉₇ conjugate vaccine; MPSV4, unconjugated quadrivalent meningococcal polysaccharide vaccine.