CVI Accepts, published online ahead of print on 7 October 2009

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Clin. Vaccine Immunol. doi:10.1128/CVI.00207-09
Copyright (c) 2009, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

Quadrivalent meningococcal vaccination in adults: A Phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra

Keith S. Reisinger^*, Roger Baxter, Stanley L. Block, Jina Shah, Lisa Bedell, and Peter M. Dull

Primary Physicians Research, Pittsburgh, Pennsylvania; Kaiser Permanente Vaccine Study Center, Oakland, California; Kentucky Pediatric and Adult Research, Inc., Bardstown, Kentucky; Novartis Vaccines and Diagnostics, Inc., Cambridge, Massachusetts

^* To whom correspondence should be addressed. Email: KSRPPR{at}aol.com.

Neisseria meningitidis is a leading cause of bacterial meningitis in the US with highest case-fatality rates reported in individuals 15 years of age. This study compares the safety and immunogenicity of the Novartis Vaccines investigational quadrivalent meningococcal CRM₁₉₇ conjugate vaccine, MenACWY-CRM, with those of the licensed meningococcal conjugate vaccine, Menactra®, when administered to healthy adults. In this Phase III multicenter study, 1359 adults 19-55 years of age were randomized to one of four groups (1:1:1:1 ratio) to receive a single dose of one of three lots of MenACWY-CRM or a single dose of Menactra. Sera obtained at baseline and 1 month post-vaccination were tested for serogroup-specific serum bactericidal activity using human complement (hSBA). The hSBA titers following vaccination with MenACWY-CRM and Menactra were compared in non-inferiority and pre-specified superiority analyses. Reactogenicity was similar between the MenACWY-CRM and Menactra groups and neither vaccine was associated with a serious adverse event. Compared with Menactra, MenACWY-CRM met the superiority criteria for the proportions of recipients achieving a seroresponse against serogroups C, W-135, and Y and the proportion of subjects achieving post-vaccination titers 1:8 for serogroups C and Y. MenACWY-CRM immunogenicity was statistically non-inferior (lower limit of the two-sided 95% confidence interval was > -10%) to Menactra for all four serogroups, with post-vaccination hSBA geometric mean titers being consistently higher for MenACWY-CRM than for Menactra. MenACWY-CRM is well tolerated in adults 19-55 years of age, with immune responses to each of the serogroups non-inferior, and in some cases statistically superior, to those to Menactra.