Tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine is well tolerated and immunogenic when co-administered with measles-mumps-rubella-varicella vaccine during the second year of life: An open, randomized controlled trial

Co-administration of meningococcal ACWY-tetanus toxoid conjugate vaccine (ACWY-TT) with MMRV vaccine was investigated in 1000 12-23-month old children randomized (3:3:1:1) to receive co-administered ACWY-TT + MMRV, or a single dose of ACWY-TT. MMRV or MenC-CRM197. Non-inferiority of ACWY-TT to MenC-CRM197 and non-inferiority of ACWY-TT + MMRV to ACWY-TT and MMRV alone, and the immunogenicity of serogroups AWY were demonstrated according to pre-defined criteria. Fever reactions in ACWY + MMRV and MMRV groups were comparable. ACWY-TT can be co-administered with MMRV without affecting immunogenicity or safety profiles of either vaccine. This study has been registered at www.clinicaltrials.gov NCT00474266. (C) 2011 Elsevier Ltd. All rights reserved.