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Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age.

Publication ,  Journal Article
Halperin, SA; Gupta, A; Jeanfreau, R; Klein, NP; Reisinger, K; Walter, E; Bedell, L; Gill, C; Dull, PM
Published in: Vaccine
November 23, 2010

BACKGROUND: Routine administration of quadrivalent meningococcal conjugate vaccine to adolescents and certain high risk groups is recommended in the United States and Canada. We compared the immunogenicity and safety of an investigational quadrivalent meningococcal vaccine conjugated to CRM-197 (MenACWY-CRM) with a licensed quadrivalent vaccine conjugated to diphtheria toxoid (MCV4) in children aged 2-10 years. METHODS: Eligible 2-5-year-olds were randomized 1:2:2 to receive either 2 doses of MenACWY-CRM, or 1 dose of MenACWY-CRM or MCV4; 6-10-year-olds were randomized 1:1 to receive a single dose of MenACWY-CRM or MCV4. The primary immunogenicity assessment was seroresponse separately for the two age cohorts 28 days following a single dose of MenACWY-CRM or MCV4. Noninferiority and superiority criteria were predefined. Solicited injection-site and systemic reactions were collected for the 7 days postvaccination. RESULTS: A total of 2907 children were randomized to receive study vaccine. MenACWY-CRM met statistical superiority criteria vs. MCV4 for groups W and Y and was noninferior for group C in both age strata. For group A, noninferiority criteria were not met; the group A seroresponse rates for MenACWY-CRM and MCV4, respectively were 72% (95% confidence interval 68-75%) and 77% (73-80%) in 2-5-year-olds and 77% (73-80%) and 83% (79-86%) in 6-10-year-olds. When the two age strata were combined (2-10-year-old children), MenACWY-CRM was noninferior to MCV4 for all four groups, and statistically superior for groups C, W, and Y. Safety parameters were similar across age cohorts and vaccines groups. CONCLUSIONS: MenACWY-CRM and MCV4 were immunogenic and well tolerated in children aged 2-10 years. Seroresponse to MenACWY-CRM was statistically noninferior to MCV4 for all groups, and statistically superior for groups C, W, and Y. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00616421.

Duke Scholars

Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

November 23, 2010

Volume

28

Issue

50

Start / End Page

7865 / 7872

Location

Netherlands

Related Subject Headings

  • Virology
  • Vaccines, Conjugate
  • Single-Blind Method
  • Meningococcal Vaccines
  • Meningococcal Infections
  • Male
  • Humans
  • Female
  • Diphtheria Toxoid
  • Child, Preschool
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Halperin, S. A., Gupta, A., Jeanfreau, R., Klein, N. P., Reisinger, K., Walter, E., … Dull, P. M. (2010). Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine, 28(50), 7865–7872. https://doi.org/10.1016/j.vaccine.2010.09.092
Halperin, Scott A., Anil Gupta, Robert Jeanfreau, Nicola P. Klein, Keith Reisinger, Emmanuel Walter, Lisa Bedell, Christopher Gill, and Peter M. Dull. “Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age.Vaccine 28, no. 50 (November 23, 2010): 7865–72. https://doi.org/10.1016/j.vaccine.2010.09.092.
Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, et al. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865–72.
Halperin, Scott A., et al. “Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age.Vaccine, vol. 28, no. 50, Nov. 2010, pp. 7865–72. Pubmed, doi:10.1016/j.vaccine.2010.09.092.
Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865–7872.
Journal cover image

Published In

Vaccine

DOI

EISSN

1873-2518

Publication Date

November 23, 2010

Volume

28

Issue

50

Start / End Page

7865 / 7872

Location

Netherlands

Related Subject Headings

  • Virology
  • Vaccines, Conjugate
  • Single-Blind Method
  • Meningococcal Vaccines
  • Meningococcal Infections
  • Male
  • Humans
  • Female
  • Diphtheria Toxoid
  • Child, Preschool