Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age
- PMID: 20943209
- DOI: 10.1016/j.vaccine.2010.09.092
Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age
Abstract
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.
Copyright © 2010 Elsevier Ltd. All rights reserved.
Similar articles
-
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. doi: 10.1086/599117. Clin Infect Dis. 2009. PMID: 19476428 Clinical Trial.
-
A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents.Pediatr Infect Dis J. 2009 Feb;28(2):86-91. doi: 10.1097/INF.0b013e31818a0237. Pediatr Infect Dis J. 2009. PMID: 19116603 Clinical Trial.
-
Quadrivalent meningococcal vaccination of adults: phase III comparison of an investigational conjugate vaccine, MenACWY-CRM, with the licensed vaccine, Menactra.Clin Vaccine Immunol. 2009 Dec;16(12):1810-5. doi: 10.1128/CVI.00207-09. Epub 2009 Oct 7. Clin Vaccine Immunol. 2009. PMID: 19812260 Free PMC article. Clinical Trial.
-
Menveo®): a novel quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135 and Y.Expert Rev Vaccines. 2011 Jan;10(1):21-33. doi: 10.1586/erv.10.147. Expert Rev Vaccines. 2011. PMID: 21162617 Review.
-
An update of clinical experience with the quadrivalent meningococcal ACWY-CRM conjugate vaccine.Expert Rev Vaccines. 2018 Oct;17(10):865-880. doi: 10.1080/14760584.2018.1521280. Epub 2018 Sep 27. Expert Rev Vaccines. 2018. PMID: 30198805 Review.
Cited by
-
Efficacy and Safety of Quadrivalent Conjugate Meningococcal Vaccines: A Systematic Review and Meta-Analysis.Vaccines (Basel). 2023 Jan 13;11(1):178. doi: 10.3390/vaccines11010178. Vaccines (Basel). 2023. PMID: 36680022 Free PMC article. Review.
-
[Health Technology Assessment (HTA) of the introduction of additional cohorts for anti-meningococcal vaccination with quadrivalent conjugate vaccines in Italy].J Prev Med Hyg. 2021 May 13;62(1 Suppl 1):E1-E128. doi: 10.15167/2421-4248/jpmh2021.62.1s1. eCollection 2021 Mar. J Prev Med Hyg. 2021. PMID: 34622076 Free PMC article. Italian. No abstract available.
-
Meningococcal Vaccination: Recommendations of the Advisory Committee on Immunization Practices, United States, 2020.MMWR Recomm Rep. 2020 Sep 25;69(9):1-41. doi: 10.15585/mmwr.rr6909a1. MMWR Recomm Rep. 2020. PMID: 33417592 Free PMC article.
-
Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP): Recommended Immunization Schedule (2020-21) and Update on Immunization for Children Aged 0 Through 18 Years.Indian Pediatr. 2021 Jan 15;58(1):44-53. doi: 10.1007/s13312-021-2096-7. Epub 2021 Nov 29. Indian Pediatr. 2021. PMID: 33257602 Free PMC article.
-
Vaccines against Meningococcal Diseases.Microorganisms. 2020 Oct 3;8(10):1521. doi: 10.3390/microorganisms8101521. Microorganisms. 2020. PMID: 33022961 Free PMC article. Review.
Publication types
MeSH terms
Substances
Associated data
LinkOut - more resources
Full Text Sources
Other Literature Sources
Medical
Miscellaneous