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Safety and Immunogenicity of a Tetravalent Polysaccharide Vaccine Against Meningococcal Disease
- Source :
- Journal of the Formosan Medical Association, Vol 108, Iss 7, Pp 539-547 (2009)
- Publication Year :
- 2009
- Publisher :
- Elsevier, 2009.
-
Abstract
- 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). Conclusion: The tetravalent polysaccharide Mencevax™ ACWY meningococcal vaccine was well tolerated and immunogenic in subjects aged 2–30 years in Taiwan.
Details
- Language :
- English
- ISSN :
- 09296646
- Volume :
- 108
- Issue :
- 7
- Database :
- Directory of Open Access Journals
- Journal :
- Journal of the Formosan Medical Association
- Publication Type :
- Academic Journal
- Accession number :
- edsdoj.bbd196008ab64c0f86f6d6156d1f7253
- Document Type :
- article
- Full Text :
- https://doi.org/10.1016/S0929-6646(09)60371-5