title: Immunogenicity and safety of a quadrivalent meningococcal polysaccharide CRM conjugate vaccine in infants and toddlers.
abstract: OBJECTIVE
  This phase III study assessed the safety and immunogenicity of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, administered with routine vaccines starting at 2 months of age.
  
  
  METHODS
  Healthy infants received MenACWY-CRM in a two- or three-dose primary infant series plus a single toddler dose. In addition, a two-dose toddler catch-up series was evaluated. Immune responses to MenACWY-CRM were assessed for serum bactericidal activity with human complement (hSBA). Reactogenicity and safety results were collected systematically.
  
  
  RESULTS
  After a full infant/toddler series or two-dose toddler catch-up series, MenACWY-CRM elicited immune responses against the four serogroups in 94-100% of subjects. Noninferiority of the two- versus three-dose MenACWY-CRM infant dosing regimen was established for geometric mean titers for all serogroups. Following the three-dose infant primary series, 89-98% of subjects achieved an hSBA ≥ 8 across all serogroups. Immune responses to concomitant routine vaccines given with MenACWY-CRM were noninferior to responses to routine vaccines alone, except for pertactin after the two-dose infant series. Noninferiority criteria were met for all concomitant antigens after the three-dose infant series.
  
  
  CONCLUSIONS
  MenACWY-CRM vaccination regimens in infants and toddlers were immunogenic and well tolerated. No clinically meaningful effects of concomitant administration with routine infant and toddler vaccines were observed.
authors: Centro de Desarrollo de Proyectos Avanzados, Córdoba, Argentina.
authors: Miguel
authors: M
authors: Tregnaghi
authors: Centro de Estudios en Infectologia Pediátrica (CEIP), Cali, Colombia.
authors: Pio
authors: P
authors: Lopez
authors: Fundación Centro de Estudios Infectológicos (FUNCEI), French 3085 (C1425AWK), Buenos Aires, Argentina.
authors: Daniel
authors: D
authors: Stamboulian
authors: Novartis Vaccines Clinical Research, Córdoba, Argentina.
authors: Gabriela
authors: G
authors: Graña
authors: Novartis Vaccines and Diagnostics, Inc., Cambridge, MA 02139, USA.
authors: Tatjana
authors: T
authors: Odrljin
authors: Novartis Vaccines and Diagnostics, Inc., Cambridge, MA 02139, USA.
authors: Lisa
authors: L
authors: Bedell
authors: Novartis Vaccines and Diagnostics, Inc., Cambridge, MA 02139, USA. Electronic address: Peter.Dull@novartis.com.
authors: Peter M
authors: PM
authors: Dull
mesh_terms: D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D009345:Neisseria meningitidis / Q000276:immunology; D065288:Serogroup; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology
chemical_list: C525703:MenACWY; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate
keywords: Conjugate vaccines; Meningitis; Meningococcal vaccines; Safety; Treatment efficacy