title: Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America.
abstract: BACKGROUND
  This study compared the investigational quadrivalent meningococcal CRM₁₉₇ conjugate vaccine, MenACWY-CRM, with licensed quadrivalent polysaccharide (MPSV4) and conjugate (MenACWY-D) meningococcal vaccines.
  
  
  METHODS
  In this phase III multicenter study, 2505 adults (aged 19-55 years) were randomized to receive either MenACWY-CRM or MenACWY-D, and 326 adults (aged 56-65 years) were randomized to receive either MenACWY-CRM or MPSV4. Sera obtained pre-vaccination and at 1-month post-vaccination were tested for serogroup-specific serum bactericidal activity using human complement (hSBA) for immunogenicity non-inferiority and superiority analyses.
  
  
  RESULTS
  The vaccines in all groups were well tolerated. In the 19-55 years age group, post-vaccination geometric mean titers (GMTs) were consistently higher for MenACWY-CRM than for MenACWY-D for all four serogroups. MenACWY-CRM was non-inferior to MenACWY-D for all serogroups, and superior for serogroup Y. In the 56-65 years age group, post-vaccination GMTs were 1.2- to 5.4-fold higher for MenACWY-CRM than for MPSV4 for the four serogroups.
  
  
  CONCLUSIONS
  MenACWY-CRM is well tolerated and immunogenic in adults aged 19-65 years, with at least non-inferior immunogenicity compared with the currently licensed meningococcal vaccines.
authors.affiliation: Fundación Centro de Estudios Infectológicos (FUNCEI), French 3085 (C1425AWK), Buenos Aires, Argentina. dstamb@funcei.org.ar
authors.forename: D
authors.initials: D
authors.lastname: Stamboulian
authors.forename: G
authors.initials: G
authors.lastname: Lopardo
authors.forename: P
authors.initials: P
authors.lastname: Lopez
authors.forename: C
authors.initials: C
authors.lastname: Cortes-Barbosa
authors.forename: A
authors.initials: A
authors.lastname: Valencia
authors.forename: L
authors.initials: L
authors.lastname: Bedell
authors.forename: A
authors.initials: A
authors.lastname: Karsten
authors.forename: P M
authors.initials: PM
authors.lastname: Dull
mesh_terms: D000328:Adult; D001118:Argentina; D003105:Colombia; D005260:Female; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D008875:Middle Aged; D018074:Vaccines, Conjugate / Q000009:adverse effects* / Q000276:immunology*
chemical_list: C556088:MenACWY-CRM vaccine; C568160:MenACWY-D vaccine; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate