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Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study.
Vaccine. 2014 Sep 08; 32(40):5177-84.V

Abstract

BACKGROUND

MenACWY-CRM (Menveo®, Novartis Vaccines, Siena, Italy) is a quadrivalent meningococcal conjugate vaccine developed to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. It is approved within the European Union in persons >2 years of age and in persons from 2 months to 55 years of age in the United States, among other countries. Little is known about the immunogenicity and safety of this vaccine in Taiwanese children >2 years and adolescents. This study assessed the immunogenicity and safety of a single injection of MenACWY-CRM vaccine in Taiwanese subjects aged 2-18 years old.

METHODS

In this phase III, multicentre, open-label study 341 subjects received one dose of MenACWY-CRM. Immunogenicity measures were rates of seroresponse (defined as the proportion of subjects with a postvaccination hSBA ≥1:8 if the prevaccination (baseline) titre was <1:4, or at least a fourfold higher hSBA titre than baseline if the prevaccination titre was ≥1:4), percentages of subjects with serum bactericidal activity (hSBA) ≥1:8 for serogroups A, C, W and Y and hSBA geometric mean titres (GMTs). Local and systemic reactions and all adverse events (AEs) were recorded for 7 days, and medically attended AEs for 1 month post-vaccination.

RESULTS

Seroresponse rates after MenACWY-CRM vaccination at Day 29 for the serogroups A, C, W, and Y were 83%, 93%, 50%, and 65%, respectively. At Day 29 the percentages of subjects with hSBA ≥1:8 against all four serogroups A, C, W and Y were: 83%, 96%, 96% and 82%, respectively. GMTs against all serogroups rose by ≥7-fold from baseline to Day 29. The vaccine was well tolerated.

CONCLUSIONS

A single dose of MenACWY-CRM demonstrated a robust immune response, and an acceptable safety profile in Taiwanese children and adolescents.

Authors+Show Affiliations

Department of Pediatrics, National Taiwan University Hospital, No. 8, Chung-Shan S. Rd., Taipei 10048, Taiwan.Department of Pediatrics, Mackay Memorial Hospital, No. 92, Sec. 2, Chung-Shan N. Rd., Taipei 10449, Taiwan.Far Eastern Memorial Hospital, No. 21, Nan-Ya S. Rd., Sec. 2, Pan-Chiao, Taipei 22060, Taiwan.Novartis Vaccines and Diagnostics, Srl., Siena, Italy.Novartis Vaccines and Diagnostics, Srl., Siena, Italy. Electronic address: ashwani_kumar.arora@novartis.com.

Pub Type(s)

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

Language

eng

PubMed ID

25075804

Citation

Huang, Li-Min, et al. "Immunogenicity and Safety of a Single Dose of a CRM-conjugated Meningococcal ACWY Vaccine in Children and Adolescents Aged 2-18 Years in Taiwan: Results of an Open Label Study." Vaccine, vol. 32, no. 40, 2014, pp. 5177-84.
Huang LM, Chiu NC, Yeh SJ, et al. Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study. Vaccine. 2014;32(40):5177-84.
Huang, L. M., Chiu, N. C., Yeh, S. J., Bhusal, C., & Arora, A. K. (2014). Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study. Vaccine, 32(40), 5177-84. https://doi.org/10.1016/j.vaccine.2014.07.063
Huang LM, et al. Immunogenicity and Safety of a Single Dose of a CRM-conjugated Meningococcal ACWY Vaccine in Children and Adolescents Aged 2-18 Years in Taiwan: Results of an Open Label Study. Vaccine. 2014 Sep 8;32(40):5177-84. PubMed PMID: 25075804.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity and safety of a single dose of a CRM-conjugated meningococcal ACWY vaccine in children and adolescents aged 2-18 years in Taiwan: results of an open label study. AU - Huang,Li-Min, AU - Chiu,Nan-Chang, AU - Yeh,Shu-Jen, AU - Bhusal,Chiranjiwi, AU - Arora,Ashwani Kumar, Y1 - 2014/07/27/ PY - 2014/03/31/received PY - 2014/06/21/revised PY - 2014/07/17/accepted PY - 2014/7/31/entrez PY - 2014/7/31/pubmed PY - 2015/3/31/medline KW - Adolescents KW - Children KW - Immunogenicity KW - Meningococcal disease KW - Quadrivalent conjugate vaccine KW - Safety SP - 5177 EP - 84 JF - Vaccine JO - Vaccine VL - 32 IS - 40 N2 - BACKGROUND: MenACWY-CRM (Menveo®, Novartis Vaccines, Siena, Italy) is a quadrivalent meningococcal conjugate vaccine developed to help prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W, and Y. It is approved within the European Union in persons >2 years of age and in persons from 2 months to 55 years of age in the United States, among other countries. Little is known about the immunogenicity and safety of this vaccine in Taiwanese children >2 years and adolescents. This study assessed the immunogenicity and safety of a single injection of MenACWY-CRM vaccine in Taiwanese subjects aged 2-18 years old. METHODS: In this phase III, multicentre, open-label study 341 subjects received one dose of MenACWY-CRM. Immunogenicity measures were rates of seroresponse (defined as the proportion of subjects with a postvaccination hSBA ≥1:8 if the prevaccination (baseline) titre was <1:4, or at least a fourfold higher hSBA titre than baseline if the prevaccination titre was ≥1:4), percentages of subjects with serum bactericidal activity (hSBA) ≥1:8 for serogroups A, C, W and Y and hSBA geometric mean titres (GMTs). Local and systemic reactions and all adverse events (AEs) were recorded for 7 days, and medically attended AEs for 1 month post-vaccination. RESULTS: Seroresponse rates after MenACWY-CRM vaccination at Day 29 for the serogroups A, C, W, and Y were 83%, 93%, 50%, and 65%, respectively. At Day 29 the percentages of subjects with hSBA ≥1:8 against all four serogroups A, C, W and Y were: 83%, 96%, 96% and 82%, respectively. GMTs against all serogroups rose by ≥7-fold from baseline to Day 29. The vaccine was well tolerated. CONCLUSIONS: A single dose of MenACWY-CRM demonstrated a robust immune response, and an acceptable safety profile in Taiwanese children and adolescents. SN - 1873-2518 UR - https://www.unboundmedicine.com/medline/citation/25075804/Immunogenicity_and_safety_of_a_single_dose_of_a_CRM_conjugated_meningococcal_ACWY_vaccine_in_children_and_adolescents_aged_2_18_years_in_Taiwan:_results_of_an_open_label_study_ DB - PRIME DP - Unbound Medicine ER -