title: Immunogenicity and Safety of a 3- and 4-dose Vaccination Series of a Meningococcal ACWY Conjugate Vaccine in Infants: Results of a Phase 3b, Randomized, Open-label Trial.
abstract: BACKGROUND
  The quadrivalent meningococcal glycoconjugate vaccine MenACWY-CRM is licensed for children from 2 months of age as a 4-dose series. This study assessed the immunogenicity of a 3-dose MenACWY-CRM vaccination series in infants, compared with the 4-dose series, and evaluated the impact of MenACWY-CRM concomitant administration on immune responses to the 13-valent pneumococcal conjugate vaccine (PCV13).
  
  
  METHODS
  Overall, 751 healthy infants (age: 55-89 days) were randomized to receive 3 or 4 doses of MenACWY-CRM (2/4/12 or 2/4/6/12 months of age, respectively) with PCV13 + routine vaccinations (ACWY3 and ACWY4 groups, respectively) or PCV13 + routine vaccinations only (routine group). Immunological noninferiority of the 3-dose versus 4-dose MenACWY-CRM vaccination series was evaluated at 13 months of age for serogroups CWY; noninferiority of immune responses to PCV13 serotypes for concomitant administration of MenACWY-CRM and PCV13 was evaluated at 7 and 13 months of age.
  
  
  RESULTS
  At 13 months, 88%-100% of subjects in groups ACWY3 and ACWY4 achieved seroprotective bactericidal antibody titers against serogroups ACWY; noninferiority criteria for the 3-dose versus 4-dose MenACWY-CRM vaccination series were met. At 7 months, noninferiority criteria were met for all PCV13 serotypes except for serotypes 3 and 5 (group ACWY3) and 19A (group ACWY4). At 13 months, noninferiority criteria were met for all PCV13 serotypes for both ACWY groups.
  
  
  CONCLUSIONS
  After completion of either MenACWY-CRM vaccination series, most subjects achieved seroprotective titers against serogroups ACWY, with the 3-dose series being noninferior to the 4-dose series for serogroups CWY, and no interference with immune responses against PCV13 serotypes was observed (NCT01214837).
authors.affiliation: From the *Kentucky Pediatric and Adult Research, Bardstown, Kentucky; †Ohio Pediatric Research Association, Dayton, Ohio; ‡Resolve Research Solutions, Ontario, Canada; §Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts; and ¶Novartis Pharma BV, Amsterdam, The Netherlands.
authors.forename: Stan L
authors.initials: SL
authors.lastname: Block
authors.forename: Julie
authors.initials: J
authors.lastname: Shepard
authors.forename: Hartley
authors.initials: H
authors.lastname: Garfield
authors.forename: Fang
authors.initials: F
authors.lastname: Xie
authors.forename: Linda
authors.initials: L
authors.lastname: Han
authors.forename: Peter M
authors.initials: PM
authors.lastname: Dull
authors.forename: Igor
authors.initials: I
authors.lastname: Smolenov
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D004347:Drug Interactions; D005260:Female; D064368:Healthy Volunteers; D006801:Humans; D007114:Immunization / Q000379:methods*; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D022242:Pneumococcal Vaccines / Q000008:administration & dosage / Q000276:immunology*; D016896:Treatment Outcome
chemical_list: C538862:13-valent pneumococcal vaccine; D000907:Antibodies, Bacterial; C556088:MenACWY-CRM vaccine; D022401:Meningococcal Vaccines; D022242:Pneumococcal Vaccines