title: Immunogenicity and safety of an investigational quadrivalent meningococcal ACWY tetanus toxoid conjugate vaccine in healthy adolescents and young adults 10 to 25 years of age.
abstract: BACKGROUND
  An investigational quadrivalent Neisseria meningitidis serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine (MenACWY-TT) has been developed to expand available options for vaccination against invasive meningococcal disease.
  
  
  METHODS
  A total of 784 healthy adolescents and young adults 11 to 25 years of age were randomized (3:1) to receive a single dose of the MenACWY-TT vaccine or a licensed MenACWY diphtheria toxoid conjugate vaccine (MenACWY-DT). An additional nonrandomized group of 88 subjects 10 years of age received the MenACWY-TT vaccine only (MenACWY-TT/10). Immunogenicity was assessed 1 month postvaccination by human complement serum bactericidal assay (hSBA) for all serogroups. Solicited local and general symptoms were recorded for 8 days postvaccination and safety outcomes for 6 months.
  
  
  RESULTS
  One month postvaccination, 81.9% to 96.1% of subjects had hSBA titers ≥ 1:8 in the MenACWY-TT group compared with 70.7% to 98.8% in the MenACWY-DT group. Exploratory analyses showed the proportion of subjects with hSBA titers ≥ 1:4 and ≥ 1:8 to be higher in the MenACWY-TT group than in the MenACWY-DT group for serogroups A, W-135, and Y. GMTs adjusted for age strata and baseline titer 1 month postvaccination were higher in the MenACWY-TT group than in the MenACWY-DT group for all 4 serogroups. The percentage of subjects reporting solicited local and general symptoms of any or Grade 3 severity or serious adverse events was similar between the 2 groups. Immune response and reactogenicity in the MenACWY-TT/10 group was similar to that in the MenACWY-TT group, except for higher hSBA-MenA GMTs in the MenACWY-TT/10 group.
  
  
  CONCLUSIONS
  The investigational MenACWY-TT vaccine was immunogenic in adolescents and young adults, with an acceptable safety profile.
authors.affiliation: Kaiser Permanente Vaccine Study Center, Oakland, CA, USA. roger.baxter@kp.org
authors.forename: Roger
authors.initials: R
authors.lastname: Baxter
authors.forename: Yaela
authors.initials: Y
authors.lastname: Baine
authors.forename: Kathleen
authors.initials: K
authors.lastname: Ensor
authors.forename: Veronique
authors.initials: V
authors.lastname: Bianco
authors.forename: Leonard R
authors.initials: LR
authors.lastname: Friedland
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Miller
mesh_terms: D000293:Adolescent; D000328:Adult; D001770:Blood Bactericidal Activity; D002648:Child; D005260:Female; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D058248:Serum Bactericidal Antibody Assay; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D014611:Vaccination / Q000379:methods*; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology; D055815:Young Adult
chemical_list: C556088:MenACWY-CRM vaccine; D022401:Meningococcal Vaccines; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate