title: Group C meningococcal polysaccharide-tetanus toxoid conjugate vaccine: a meta-analysis of immunogenicity, safety and posology.
abstract: A conjugate vaccine comprised of de-O-acetylated group C meningococcal polysaccharide coupled to tetanus toxoid (GCMP-TT) has been licensed in 32 countries and incorporated in a comprehensive UK vaccination program. Extensive evidence, forming the subject of this meta-analysis, has rapidly accumulated on the immunogenicity, safety and posology of GCMP-TT as well as its epidemiological impact. GCMP-TT has been shown effective after a single dose in individuals >12 months of age, and initial posology specified three doses in infants. However, based on a recent clinical trial, posology was reduced to two doses in infants. Pooled protection rate, defined as proportion of subjects with serum bactericidal antibody (SBA) levels > or = 1:8, was 99.4% (CI, 98.2-99.9%) in seven clinical trials covering all age groups. Robust responses to GCMP-TT have been demonstrated with respect to SBA, IgG levels and antibody avidity. In post-marketing pharmacosurveillance encompassing >12 x 10(6) GCMP-TT doses distributed worldwide, the vaccine has been well tolerated with an incidence rate of 0.01% for all the most commonly encountered types of adverse events. After a catch-up UK vaccination campaign where 5-8 year old children were primarily given GCMP-TT, a 93% decline in meningococcal disease incidence was observed. In view of its immunogenicity, safety and potential suitability for use among infants in reduced dose schedules, GCMP-TT appears to mark a major advance over predecessor polysaccharide vaccines for the prevention of meningococcal C disease.
authors.affiliation: Baxter BioScience, Vienna, Austria. eva_maria_poellabauer@baxter.com
authors.forename: Eva Maria
authors.initials: EM
authors.lastname: Pöllabauer
authors.forename: Robert
authors.initials: R
authors.lastname: Petermann
authors.forename: Hartmut J
authors.initials: HJ
authors.lastname: Ehrlich
mesh_terms: D000907:Antibodies, Bacterial / Q000032:analysis / Q000096:biosynthesis; D002648:Child; D002675:Child, Preschool; D023381:Endpoint Determination; D006801:Humans; D007115:Immunization Schedule; D007156:Immunologic Memory / Q000276:immunology; D007223:Infant; D008585:Meningitis, Meningococcal / Q000453:epidemiology / Q000276:immunology / Q000517:prevention & control; D022401:Meningococcal Vaccines / Q000009:adverse effects / Q000276:immunology*; D038542:Neisseria meningitidis, Serogroup C / Q000276:immunology*; D011134:Polysaccharides / Q000009:adverse effects / Q000276:immunology; D013745:Tetanus Toxoid / Q000009:adverse effects / Q000276:immunology*; D006113:United Kingdom / Q000453:epidemiology; D018074:Vaccines, Conjugate
chemical_list: D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines; D011134:Polysaccharides; D013745:Tetanus Toxoid; D018074:Vaccines, Conjugate