Invasive meningococcal disease

This information is intended for global use. Please consult the appropriate country-specific Baxter website for more information. Some statements about products or procedures may differ from the licensed indications in specific countries. Therefore, always consult the country-specific summary of product characteristics (SPC), package leaflets or instructions for use. For more information, please contact a local Baxter representative.

Invasive meningococcal disease is a contagious and life threatening infection caused by Neisseria meningitidis, a Gram-negative endotoxin-producing organism unique for its ability to cause epidemic disease.¹

Transmission of meningococcal bacteria:

Humans are the only reservoir for meningococci. Meningococcal disease occurs worldwide, showing considerable geographic variability in serogroup distribution.² In many parts of the world, meningococcal disease is the leading cause of bacterial meningitis and septicaemia. Regardless of serogroup, the highest incidence of meningococcal disease occurs in young children.

Based on the chemical and immunologic specificity of the capsular polysaccharides, the genus Neisseria can be divided into at least 13 serogroups, of which A, B, C, W-135, X and Y account for almost all cases of disease. Polysaccharides are specific to each serogroup and essential to pathogenicity. Therefore, the risk of epidemic disease may differ considerably between serogroups.

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The state of the art of preventing meningococcal infection is active immunization with conjugate vaccines, which have now been available for a number of years. Monovalent group C conjugate vaccines, such as Baxter’s meningococcal group C polysaccharide conjugate vaccine (MCC), were first introduced in the UK in 1999 and are now widely used in other European countries, Canada, and Australia. In 2005, a tetravalent meningococcal A, C, W-135, and Y conjugate vaccine was registered in the US and is recommended for routine use in teenagers and young adults.³

The Men C conjugate vaccine by Baxter is a meningococcal group C polysaccharide conjugate vaccine (MCC) adsorbed on aluminium hydroxide. It is composed of group C meningococcal de-O-acetylated capsular polysaccharide coupled to purified tetanus toxoid (TT). It differs from other MCC vaccines by the proprietary de-acetylation of the polysaccharide and the use of TT as carrier protein.

During its clinical development, Baxter’s meningococcal group C polysaccharide conjugate vaccine (MCC) was evaluated in a series of clinical studies covering all age groups from infant, toddlers, children and adolescent to adults.^5-11

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^{1. Granoff DM, Harrison LH, Borrow R. Meningococcal vaccines. In: Plotkin, ed. Vaccines: Elsevier, 2008.}

^{2. Stephens DS, Greenwood B, Brandtzaeg P. Epidemic meningitis, meningococcaemia, and Neisseria meningitidis. Lancet 2007; 369:2196-210.}

^{3. Bilukha OO, Rosenstein N. Prevention and control of meningococcal disease. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep 2005; 54:1-21.}

^{4. Borrow R, Goldblatt D, Finn A, et al. Immunogenicity of, and immunologic memory to, a reduced primary schedule of meningococcal C-tetanus toxoid conjugate vaccine in infants in the United Kingdom. Infect Immun 2003; 71:5549-55.}

^{5. Southern J, Crowley-Luke A, Borrow R, Andrews N, Miller E. Immunogenicity of one, two or three doses of a meningococcal C conjugate vaccine conjugated to tetanus toxoid, given as a three-dose primary vaccination course in UK infants at 2, 3 and 4 months of age with acellular pertussis-containing DTP/Hib vaccine. Vaccine 2006; 24:215-9.}

^{6. Richmond P, Borrow R, Findlow J, et al. Evaluation of De-O-acetylated meningococcal C polysaccharide-tetanus toxoid conjugate vaccine in infancy: reactogenicity, immunogenicity, immunologic priming, and bactericidal activity against O-acetylated and De-O-acetylated serogroup C strains. Infect Immun 2001; 69:2378-82.}

^{7. Richmond P, Borrow R, Goldblatt D, et al. Ability of 3 different meningococcal C conjugate vaccines to induce immunologic memory after a single dose in UK toddlers. J Infect Dis 2001; 183:160-3.}

^{8. Richmond P, Goldblatt D, Fusco PC, et al. Safety and immunogenicity of a new Neisseria meningitidis serogroup C-tetanus toxoid conjugate vaccine in healthy adults. Vaccine 2000; 18:641-6.}

^{9. Southern J, Deane S, Ashton L, et al. Effects of prior polysaccharide vaccination on magnitude, duration, and quality of immune responses to and safety profile of a meningococcal serogroup C tetanus toxoid conjugate vaccination in adults. Clin Diagn Lab Immunol 2004; 11:1100-4.}

^{10. Burrage M, Robinson A, Borrow R, et al. Effect of vaccination with carrier protein on response to meningococcal C conjugate vaccines and value of different immunoassays as predictors of protection. Infect Immun 2002; 70:4946-54.}

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