Safety and immunogenicity of a tetravalent polysaccharide vaccine against meningococcal disease.
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.
Shao
Pei-Lan
PL
Department of Pediatrics, National Taiwan University Hospital, Taipei, Taiwan.
Chang
Luan-Yin
LY
Hsieh
Szu-Min
SM
Chang
Shan-Chwen
SC
Pan
Sung-Ching
SC
Lu
Chun-Yi
CY
Hsieh
Yu-Chia
YC
Lee
Chin-Yun
CY
Dobbelaere
Kurt
K
Boutriau
Dominique
D
Tang
Haiwen
H
Bock
Hans L
HL
Huang
Li-Min
LM
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
D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines