Journal Article

Phase III Comparison of an Investigational Quadrivalent Meningococcal Conjugate Vaccine with the Licensed Meningococcal ACWY Conjugate Vaccine in Adolescents

Lisa A. Jackson, Roger Baxter, Keith Reisinger, Annette Karsten, Jina Shah, Lisa Bedell and Peter M. Dull

in Clinical Infectious Diseases

Published on behalf of Infectious Diseases Society of America

Volume 49, issue 1, pages e1-e10
Published in print July 2009 | ISSN: 1058-4838
Published online July 2009 | e-ISSN: 1537-6591 | DOI: http://dx.doi.org/10.1086/599117
Phase III Comparison of an Investigational Quadrivalent Meningococcal Conjugate Vaccine with the Licensed Meningococcal ACWY Conjugate Vaccine in Adolescents

More Like This

Show all results sharing these subjects:

  • Infectious Diseases
  • Immunology
  • Public Health and Epidemiology
  • Microbiology

GO

Show Summary Details

Preview

Background. Neisseria meningitidis is an important cause of invasive bacterial infection in the United States, and disease rates are higher for adolescents than for the general population. Quadrivalent meningococcal conjugate vaccine is recommended for routine vaccination of adolescents and high-risk groups. This study compares the safety and immunogenicity of the Novartis Vaccines investigational quadrivalent meningococcal CRM197conjugate vaccine, MenACWY-CRM, with the licensed meningococcal conjugate vaccine, Menactra.

Methods. In this multicenter phase III study, 2180 adolescents 11–18 years of age were randomly assigned to 4 groups (1:1:1:1) to receive a single dose of 1 of 3 lots of MenACWY-CRM or a single dose of Menactra. Serum samples obtained before vaccination and 1 month after vaccination were tested for serogroup-specific serum bactericidal activity using human complement (hSBA). The hSBA titers after vaccination with MenACWY-CRM or Menactra were compared in noninferiority and superiority analyses.

Results. The hSBA geometric mean titers after MenACWY-CRM vaccination were higher than the hSBA geometric mean titers after Menactra vaccination, and criteria for superiority were met for this end point for all 4 serogroups. Also, the criteria for superiority of MenACWY-CRM, compared with Menactra, were met for the end points of proportion of subjects with postvaccination hSBA titers ⩾1:8 and proportion of seroresponders for serogroups A, W-135, and Y. MenACWY-CRM was noninferior to Menactra for serogroup C for these end points. Reactogenicity was similar, with 64% of the MenACWY-CRM recipients and 70% of the Menactra recipients reporting mild and/or moderate solicited reactions. Neither vaccine was associated with a serious adverse event.

Conclusions. MenACWY-CRM vaccine is well tolerated in adolescents and generates a stronger immune response than Menactra for all 4 serogroups.

Trial registration. Clinicaltrials.gov identifier: NCT00450437.

Journal Article.  4961 words.  Illustrated.

Subjects: Infectious Diseases ; Immunology ; Public Health and Epidemiology ; Microbiology

Full text: subscription required

How to subscribe Recommend to my Librarian

Users without a subscription are not able to see the full content. Please, subscribe or login to access all content.