Published in

Elsevier, Journal of the Formosan Medical Association, 7(108), p. 539-547, 2009

DOI: 10.1016/s0929-6646(09)60371-5

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Safety and immunogenicity of a tetravalent polysaccharide vaccine against meningococcal disease.

This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Abstract

Background/Purpose: Meningococcal disease, including meningitis and sepsis, usually follows ail 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 GIaxoSmithKline Biologicals' Mencevax (TM) 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 (TM ) 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 I month after vaccination with Mencevax (TM) 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). Conclusion: The tetravalent polysaccharide Mencevax (TM) ACWY meningococcal vaccine was well tolerated and immunogenic in subjects aged 2-30 years in Taiwan. ; 附設醫院檢驗醫學部 ; 醫學院附設醫院 ; 期刊論文