PMID- 19895922 OWN - NLM STAT- MEDLINE DCOM- 20100203 LR - 20131121 IS - 1873-2518 (Electronic) IS - 0264-410X (Linking) VI - 28 IP - 3 DP - 2010 Jan 8 TI - Immunogenicity and tolerability of a quadrivalent meningococcal glycoconjugate vaccine in children 2-10 years of age. PG - 657-63 LID - 10.1016/j.vaccine.2009.10.104 [doi] AB - Meningococcal disease incidence is highest in infants, but a significant burden of disease also occurs in children. In this Phase II, single-centre US study, 619 healthy children (2-10 years of age) received one dose of an investigational quadrivalent meningococcal CRM(197)-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 1 and 12 months post-vaccination. Local and systemic reactions were recorded for 7 days, all adverse events (AEs) for 1 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 >or=1:4 at 1 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. FAU - Black, S AU - Black S AD - Center for Global Child Health, Cincinnati Children's Hospital, Cincinnati, Ohio, USA. steven.black1@cchmc.org FAU - Klein, N P AU - Klein NP FAU - Shah, J AU - Shah J FAU - Bedell, L AU - Bedell L FAU - Karsten, A AU - Karsten A FAU - Dull, P M AU - Dull PM LA - eng PT - Clinical Trial, Phase II PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20091104 PL - Netherlands TA - Vaccine JT - Vaccine JID - 8406899 RN - 0 (Antibodies, Bacterial) RN - 0 (Meningococcal Vaccines) RN - 0 (Vaccines, Conjugate) RN - 9007-36-7 (Complement System Proteins) SB - IM MH - Antibodies, Bacterial/blood MH - Blood Bactericidal Activity MH - Child MH - Child, Preschool MH - Complement System Proteins/immunology MH - Drug-Related Side Effects and Adverse Reactions MH - Female MH - Humans MH - Male MH - Meningococcal Infections/*prevention & control MH - Meningococcal Vaccines/*administration & dosage/*immunology MH - Time Factors MH - United States MH - Vaccines, Conjugate/administration & dosage/immunology EDAT- 2009/11/10 06:00 MHDA- 2010/02/04 06:00 CRDT- 2009/11/10 06:00 PHST- 2009/02/10 00:00 [received] PHST- 2009/10/14 00:00 [revised] PHST- 2009/10/19 00:00 [accepted] PHST- 2009/11/10 06:00 [entrez] PHST- 2009/11/10 06:00 [pubmed] PHST- 2010/02/04 06:00 [medline] AID - S0264-410X(09)01655-7 [pii] AID - 10.1016/j.vaccine.2009.10.104 [doi] PST - ppublish SO - Vaccine. 2010 Jan 8;28(3):657-63. doi: 10.1016/j.vaccine.2009.10.104. Epub 2009 Nov 4.