title: Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine and Commonly Administered Vaccines After Coadministration.
abstract: BACKGROUND
  Given the broad age range across which the quadrivalent meningococcal conjugate vaccine MenACWY-CRM is used, coadministration with routine vaccines should be evaluated across age groups for possible immunologic interference and impact on vaccine reactogenicity and safety.
  
  
  METHODS
  We summarize data from a large population of infants, adolescents and international travelers from 10 phase 3 or 4 clinical studies to evaluate coadministration of MenACWY-CRM with commonly administered vaccines. Noninferiority analyses of immune responses were performed across studies and age groups for each vaccine. Reactogenicity and safety were also assessed.
  
  
  RESULTS
  In infants, MenACWY-CRM coadministered with routine vaccines did not reduce immune responses to diphtheria, tetanus, poliovirus, hepatitis B, Haemophilus influenzae type b, pneumococcal conjugate, measles-mumps-rubella, varicella or pertussis antigens. Noninferiority criteria were not met for some pneumococcal conjugate serotypes at 7 months of age, but no consistent trends were observed. In adolescents, coadministration did not reduce immune responses to tetanus, diphtheria and human papilloma virus vaccine antigens. Noninferiority criteria for pertussis antigens were not uniformly met in infant and adolescent studies, although the clinical relevance is unclear. In adults, coadministration did not reduce immune responses to hepatitis A/B, typhoid fever, yellow fever, Japanese encephalitis and rabies antigens. Immune responses to MenACWY-CRM were not impacted by coadministration of commonly administered vaccines. Coadministration did not increase frequencies of postvaccination adverse events in any age group.
  
  
  CONCLUSIONS
  With no clinically relevant vaccine interactions or impact on vaccine reactogenicity or safety, these results support the coadministration of MenACWY-CRM with routine vaccines in all age groups.
authors.affiliation: From the *Department of Health Sciences, University of Genoa, Genoa, Italy; †Department of Clinical Research Center Developing Advanced Projects (CEDEPAP), Córdoba, Argentina; ‡Global Clusters, Research and Development, Novartis Pharma BV, Amsterdam, The Netherlands; §Biostatistics and Statistical Reporting, Novartis Pharma BV, Amsterdam, The Netherlands; and ¶Global Clusters, Research and Development, Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts.
authors.forename: Roberto
authors.initials: R
authors.lastname: Gasparini
authors.forename: Miguel
authors.initials: M
authors.lastname: Tregnaghi
authors.forename: Pavitra
authors.initials: P
authors.lastname: Keshavan
authors.forename: Ellen
authors.initials: E
authors.lastname: Ypma
authors.forename: Linda
authors.initials: L
authors.lastname: Han
authors.forename: Igor
authors.initials: I
authors.lastname: Smolenov
mesh_terms: D000293:Adolescent; D000367:Age Factors; D017326:Clinical Trials, Phase III as Topic; D017327:Clinical Trials, Phase IV as Topic; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D008585:Meningitis, Meningococcal / Q000276:immunology*; D008589:Meningococcal Infections / Q000276:immunology* / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D014611:Vaccination; D014612:Vaccines / Q000008:administration & dosage / Q000276:immunology
chemical_list: C556088:MenACWY-CRM vaccine; D022401:Meningococcal Vaccines; D014612:Vaccines