Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age

Meningococcal disease incidence is highest in infants, but a significant burden of disease also Occurs in children In this Phase 11, single-centre US study, 619 healthy children (2-10 years of age) received one dose of an investigational quadrivalent meningococcal CRM197-conjugated vaccine (MenACWY-CRM) or a licensed quadrivalent meningococcal polysaccharide vaccine (MPSV4) Immunogenicity was assessed using the serum bactericidal assay with human complement (hSBA) at I and 12 months post-vaccination. Local and systemic reactions were recorded for 7 days, all adverse events (AEs) for I month, and medically significant and serious AEs (SAEs) for 12 months post-vaccination For all four serogroups, more MenACWY-CRM recipients achieved an hSBA titre >= 1 4 at I month post-vaccination (A: 82%: C: 83%: W-135 95%: Y 91%) compared with the group that received MPSV4 (A 45%, C 66%; W-135 71%: Y: 61%). this difference persisted through to 12 months post-vaccination. Both vaccines were well tolerated. In children 2-10 years of age, MenACWY-CRM induced a higher Immune response than that of MPSV4, and was well tolerated (C) 2009 Published by Elsevier Ltd.