Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents.
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 CRM(197) conjugate 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.


BACKGROUND
Clinicaltrials.gov identifier: NCT00450437 .
Jackson
Lisa A
LA
Group Health Center for Health Studies, Seattle, Washington 98101, USA. jackson.l@ghc.org
Baxter
Roger
R
Reisinger
Keith
K
Karsten
Annette
A
Shah
Jina
J
Bedell
Lisa
L
Dull
Peter M
PM
D000293:Adolescent; D001770:Blood Bactericidal Activity; D002648:Child; D003165:Complement System Proteins / Q000276:immunology; D005260:Female; D006801:Humans; D008297:Male; D008589:Meningococcal Infections / Q000517:prevention & control*; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D014481:United States; D018074:Vaccines, Conjugate / Q000009:adverse effects / Q000276:immunology
C525703:MenACWY; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate; D003165:Complement System Proteins