Safety of a quadrivalent meningococcal serogroups A, C, W and Y conjugate vaccine (MenACWY-CRM) administered with routine infant vaccinations: results of an open-label, randomized, phase 3b controlled study in healthy infants.

•Similar rates of solicited systemic reactions with or without MenACWY-CRM.•Percentage of SAEs in both groups similar at all follow-up points.•Similar type and incidence of AEs evident for both vaccinations groups.•No difference in study discontinuation rates between the groups.•Findings support concomitant administration of MenACWY-CRM with routine vaccination.