title: Safety and immunogenicity of a tetravalent polysaccharide vaccine against meningococcal disease.
abstract: OBJECTIVE
  Meningococcal disease, including meningitis and sepsis, usually follows an invasive infection by Neisseria meningitidis, and is a major cause of death and morbidity worldwide. Currently available meningococcal vaccines that consist of pure capsular polysaccharides (serogroups A, C, W-135 and Y) are generally safe and efficacious in adults and children aged > 2 years. The purpose of this study was to evaluate the immunogenicity, safety and reactogenicity of a single dose of GlaxoSmithKline Biologicals' Mencevax ACWY vaccine in healthy Taiwanese subjects aged 2-30 years.
  
  
  METHODS
  This open, single center, Phase III study was conducted in Taiwan. A single dose of the Mencevax ACWY vaccine was administered to subjects aged 2-30 years. Immunogenicity and safety of the vaccine were evaluated after vaccination.
  
  
  RESULTS
  The immunogenicity results obtained 1 month after vaccination with Mencevax ACWY vaccine indicated that the vaccine elicited a good immune response in vaccinees aged 2-30 years. This was both in terms of functional activity directed against meningococcal polysaccharide (A, C, W-135 and Y) as measured by serum bactericidal assay (> 93% activity against all serogroups), and specific IgG concentrations measured by ELISA (> 96% seropositivity to all serogroups).
  
  
  CONCLUSIONS
  The tetravalent polysaccharide Mencevax ACWY meningococcal vaccine was well tolerated and immunogenic in subjects aged 2-30 years in Taiwan.
authors: Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.
authors: Pei-Lan
authors: PL
authors: Shao
authors: Luan-Yin
authors: LY
authors: Chang
authors: Szu-Min
authors: SM
authors: Hsieh
authors: Shan-Chwen
authors: SC
authors: Chang
authors: Sung-Ching
authors: SC
authors: Pan
authors: Chun-Yi
authors: CY
authors: Lu
authors: Yu-Chia
authors: YC
authors: Hsieh
authors: Chin-Yun
authors: CY
authors: Lee
authors: Kurt
authors: K
authors: Dobbelaere
authors: Dominique
authors: D
authors: Boutriau
authors: Haiwen
authors: H
authors: Tang
authors: Hans L
authors: HL
authors: Bock
authors: Li-Min
authors: LM
authors: Huang
mesh_terms: D000293:Adolescent; D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D001770:Blood Bactericidal Activity; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D009345:Neisseria meningitidis / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines