AUG 25, 2026 · JOURNAL ARTICLE
Safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in USA and Puerto Rico: Results from a Phase III, randomized, active-controlled study.
Human Vaccines & Immunotherapeutics
Phase III randomized controlled trial with adequate sample size (2,777 participants) and active comparator, demonstrating comparable safety profiles between MenACYW-TT and MenACWY-CRM with systematic adverse event monitoring; rigorous design supports but does not alone change clinical practice.
Reported
Sample size (MenACYW-TT group)2080
Sample size (MenACWY-CRM group)697
Solicited injection site reaction…84.9%