Comparative trial of the safety and immunogenicity of quadrivalent (A, C, Y, W-135) meningococcal polysaccharide-diphtheria conjugate vaccine versus quadrivalent polysaccharide vaccine in two- to ten-year-old children

• Published in: The Pediatric infectious disease journal Vol. 24; no. 1; p. 57
• Main Authors: Pichichero, Michael, Casey, Janet, Blatter, Mark, Rothstein, Edward, Ryall, Robert, Bybel, Mike, Gilmet, Gregory, Papa, Thomas
• Format: Journal Article
• Language: English
• Published: United States 01.01.2005
• Subjects: Antibodies, Bacterial - blood; Child; Child, Preschool; Diphtheria Toxoid - immunology; Double-Blind Method; Humans; Meningococcal Infections - prevention & control; Meningococcal Vaccines - administration & dosage; Meningococcal Vaccines - adverse effects; Meningococcal Vaccines - immunology; Neisseria meningitidis - classification; Neisseria meningitidis - immunology; Polysaccharides, Bacterial - immunology; Serotyping; Vaccines, Conjugate - administration & dosage; Vaccines, Conjugate - adverse effects; Vaccines, Conjugate - immunology
• ISSN: 0891-3668
• DOI: 10.1097/01.inf.0000148928.10057.86

A quadrivalent meningococcal diphtheria conjugate vaccine (MCV-4) has been developed to provide T-cell dependent immune responses against 4 major disease-causing serogroups (A, C, Y, W-135). In a comparative, randomized, modified double blind, controlled study in healthy 2- to 10-year-old U.S. children, safety and immunogenicity profiles of MCV-4 (n = 696) were compared with those of a licensed quadrivalent polysaccharide vaccine, Menomune A/C/Y/W-135 (PSV-4, n = 702). Vaccine-related adverse reactions were assessed for 28-day and 6-month follow-up periods. Serum bactericidal activity (SBA) was assayed in prevaccination, day 28 and 6-month postvaccination sera samples. Both vaccines were well-tolerated, with no vaccine-related serious adverse events and similar rates of mostly mild local and systemic reactions. Functional antibody (SBA) seroconversion percentages were significantly higher for all 4 serogroups in the MCV-4 group. The SBA geometric mean titers against serogroups A, C, Y and W-135 with MCV-4 were 1700, 354, 637 and 750, respectively, compared with PSV-4 (893, 231, 408 and 426) 28 days postvaccination (P < 0.001 for all comparisons). This significant difference persisted through 6 months. In 2- to 10-year-old children MCV-4 had a safety profile similar to that of PSV-4 and elicited significantly higher and more persistent serum bactericidal antibody responses against meningococcal serogroups A, C, Y and W-135 than did the licensed polysaccharide vaccine.