title: Safety and immunogenicity of a novel quadrivalent meningococcal CRM-conjugate vaccine given concomitantly with routine vaccinations in infants.
abstract: BACKGROUND
  In phase II studies, MenACWY-CRM elicited robust immunologic responses in young infants. We now present results from our pivotal phase III infant immunogenicity/safety study.
  
  
  METHODS
  In this open-label phase III study, we randomized full-term 2-month-old infants to 4 doses of MenACWY-CRM coadministered with routine vaccines at 2, 4, 6, and 12 months of age or with routine vaccines alone. We monitored for local and systemic reactions and serious adverse events among all study participants and evaluated for sufficiency of the immune responses to MenACWY-CRM through serum bactericidal activity assay with human complement.
  
  
  RESULTS
  Bactericidal antibodies were present in 94% to 100% of subjects against each of the serogroups in MenACWY-CRM after the 4-dose series and were 67% to 97% after the first 3 doses. Geometric mean titers were higher after the fourth dose of MenACWY-CRM compared with a single dose of MenACWY-CRM at 12 months of age for all serogroups (range of ratios, 4.5-38). Responses to 3 doses of routine vaccines coadministered with MenACWY-CRM were noninferior to routine vaccinations alone, except for small differences in pneumococcal serotype 6B responses after dose 3 but not dose 4 and pertactin after dose 3. Inclusion of MenACWY-CRM did not affect the safety or reactogenicity profiles of the routine infant vaccine series.
  
  
  CONCLUSIONS
  A 4-dose series of MenACWY-CRM was highly immunogenic and well tolerated in young infants, and it can be coadministered with routine infant vaccines. Substantial immunity was conferred after the first 3 doses administered at 2, 4, and 6 months of age.
authors.affiliation: Kaiser Permanente Vaccine Study Center, Oakland, CA 94612, USA. Nicola.Klein@kp.org
authors.forename: Nicola P
authors.initials: NP
authors.lastname: Klein
authors.forename: Keith S
authors.initials: KS
authors.lastname: Reisinger
authors.forename: William
authors.initials: W
authors.lastname: Johnston
authors.forename: Tatjana
authors.initials: T
authors.lastname: Odrljin
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Gill
authors.forename: Lisa
authors.initials: L
authors.lastname: Bedell
authors.forename: Peter
authors.initials: P
authors.lastname: Dull
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood*; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007223:Infant; D008297:Male; D008589:Meningococcal Infections / Q000276:immunology / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D009345:Neisseria meningitidis; D016896:Treatment Outcome; D014481:United States; D014611:Vaccination; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; C525703:MenACWY; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate