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Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents.
Clin Infect Dis. 2009 Jul 01; 49(1):e1-10.CI

Abstract

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.

TRIAL REGISTRATION

Clinicaltrials.gov identifier: NCT00450437 .

Authors+Show Affiliations

Group Health Center for Health Studies, Seattle, Washington 98101, USA. jackson.l@ghc.orgNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19476428

Citation

Jackson, Lisa A., et al. "Phase III Comparison of an Investigational Quadrivalent Meningococcal Conjugate Vaccine With the Licensed Meningococcal ACWY Conjugate Vaccine in Adolescents." Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, vol. 49, no. 1, 2009, pp. e1-10.
Jackson LA, Baxter R, Reisinger K, et al. Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clin Infect Dis. 2009;49(1):e1-10.
Jackson, L. A., Baxter, R., Reisinger, K., Karsten, A., Shah, J., Bedell, L., & Dull, P. M. (2009). Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America, 49(1), e1-10. https://doi.org/10.1086/599117
Jackson LA, et al. Phase III Comparison of an Investigational Quadrivalent Meningococcal Conjugate Vaccine With the Licensed Meningococcal ACWY Conjugate Vaccine in Adolescents. Clin Infect Dis. 2009 Jul 1;49(1):e1-10. PubMed PMID: 19476428.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Phase III comparison of an investigational quadrivalent meningococcal conjugate vaccine with the licensed meningococcal ACWY conjugate vaccine in adolescents. AU - Jackson,Lisa A, AU - Baxter,Roger, AU - Reisinger,Keith, AU - Karsten,Annette, AU - Shah,Jina, AU - Bedell,Lisa, AU - Dull,Peter M, AU - ,, PY - 2009/5/30/entrez PY - 2009/5/30/pubmed PY - 2009/7/28/medline SP - e1 EP - 10 JF - Clinical infectious diseases : an official publication of the Infectious Diseases Society of America JO - Clin Infect Dis VL - 49 IS - 1 N2 - 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. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00450437 . SN - 1537-6591 UR - https://www.unboundmedicine.com/medline/citation/19476428/Phase_III_comparison_of_an_investigational_quadrivalent_meningococcal_conjugate_vaccine_with_the_licensed_meningococcal_ACWY_conjugate_vaccine_in_adolescents_ L2 - https://academic.oup.com/cid/article-lookup/doi/10.1086/599117 DB - PRIME DP - Unbound Medicine ER -