title: Immunogenicity of a single dose of tetravalent meningococcal serogroups A, C, W-135, and Y conjugate vaccine administered to 2- to 10-year-olds is noninferior to a licensed-ACWY polysaccharide vaccine with an acceptable safety profile.
abstract: BACKGROUND
  Meningococcal disease remains an important cause of invasive bacterial infections in children less than 5 years of age. Immunogenicity and safety of the investigational ACWY vaccine conjugated with tetanus toxoid (ACWY-TT, GlaxoSmithKline Biologicals) were evaluated in 1501 healthy 2- to 10-year-old children in the Philippines, India, Lebanon, and Saudi Arabia.
  
  
  METHODS
  Children were randomized (3:1) to receive ACWY-TT or licensed tetravalent meningococcal polysaccharide vaccine (Mencevax, GlaxoSmithKline, Men-PS). Diary cards were used to collect solicited symptoms for 4 days after vaccination. Serious adverse events were reported for 6 months. Serum bactericidal activity (rSBA, rabbit complement) was measured before and 1 month after vaccination in the first 75% of subjects enrolled in each country.
  
  
  RESULTS
  The statistical criteria for noninferiority in terms of rSBA vaccine responses were reached. Exploratory analyses showed that postvaccination rSBA titers ≥ 1:8 and ≥ 1:128 were significantly higher after ACWY-TT than Men-PS for serogroups C, W-135, and Y, and rSBA vaccine responses and geometric mean antibody titers were significantly higher for all 4 serogroups after administration of ACWY-TT. Noninferiority in terms of incidences of grade 3 general symptoms was not demonstrated. ACWY-TT was well tolerated with grade 3 events reported in <1% of subjects per group. No serious adverse events were considered related to vaccination.
  
  
  CONCLUSIONS
  ACWY-TT was immunogenic in children between 2 to 10 years of age with a clinically acceptable safety profile that resembled licensed Men-PS. These data support a positive benefit/risk ratio for the ACWY-TT vaccine.
authors.affiliation: National Guard Affairs, King Abdulaziz Medical City, Riyadh, Saudi Arabia.
authors.forename: Ziad A
authors.initials: ZA
authors.lastname: Memish
authors.forename: Ghassan
authors.initials: G
authors.lastname: Dbaibo
authors.forename: May
authors.initials: M
authors.lastname: Montellano
authors.forename: Valsan P
authors.initials: VP
authors.lastname: Verghese
authors.forename: Hemant
authors.initials: H
authors.lastname: Jain
authors.forename: A P
authors.initials: AP
authors.lastname: Dubey
authors.forename: Veronique
authors.initials: V
authors.lastname: Bianco
authors.forename: Marie
authors.initials: M
authors.lastname: Van der Wielen
authors.forename: Salvacion
authors.initials: S
authors.lastname: Gatchalian
authors.forename: Jacqueline M
authors.initials: JM
authors.lastname: Miller
mesh_terms: D001770:Blood Bactericidal Activity; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007194:India; D007861:Lebanon; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D010679:Philippines; D012529:Saudi Arabia; D013745:Tetanus Toxoid / Q000008:administration & dosage; D014611:Vaccination / Q000379:methods; D018074:Vaccines, Conjugate / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D022401:Meningococcal Vaccines; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate