Immunogenicity and safety of the quadrivalent meningococcal vaccine MenACWY-TT co-administered with a combined diphtheria-tetanus-acellular pertussis vaccine versus their separate administration in adolescents and young adults: A phase III, randomized study
DC Field | Value | Language |
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dc.contributor.author | Rivera, Luis | - |
dc.contributor.author | Schwarz, Tino F. | - |
dc.contributor.author | Kim, Kyung-Hyo | - |
dc.contributor.author | Kim, Yun-Kyung | - |
dc.contributor.author | Behre, Ulrich | - |
dc.contributor.author | Cha, Sung-Ho | - |
dc.contributor.author | Jo, Dae Sun | - |
dc.contributor.author | Lee, Jacob | - |
dc.contributor.author | Lee, Jin-Soo | - |
dc.contributor.author | Cheuvart, Brigitte | - |
dc.contributor.author | Jastorff, Archana | - |
dc.contributor.author | Van der Wielen, Marie | - |
dc.date.accessioned | 2021-09-02T08:53:14Z | - |
dc.date.available | 2021-09-02T08:53:14Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2018-07-25 | - |
dc.identifier.issn | 0264-410X | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/74310 | - |
dc.description.abstract | Background: This study evaluated the immunogenicity and safety of quadrivalent meningococcal conjugate vaccine using tetanus (T) toxoid as carrier protein (MenACWY-TT) co-administered with combined diphtheria-tetanus-acellular pertussis vaccine (Tdap) versus their separate administration in adolescents and young adults. Methods: In this phase III, randomized, partially-blind study (NCT01767376), healthy 11-25-year-olds (N = 660) were randomized (1:1:1) to receive MenACWY-TT and Tdap at Month 0 (Co-ad group), MenACVVY-TT at Month 0 and Tdap at Month 1 (ACWY_Tdap group) or Tdap at Month 0 and MenACVVY-TT at Month 1 (Tdap_ACWY group). Immune responses to MenACWY-TT were measured by serum bactericidal assay using rabbit complement (rSBA). Anti-diphtheria (D), anti-tetanus (T), anti-pertussis toxin (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibody concentrations were assessed using enzyme-linked immunosorbent assays. Non-inferiority of immunogenicity was assessed using pre-defined clinical criteria. Safety was also evaluated. Results: Non-inferiority of immunogenicity of MenACWY-TT and Tdap when co-administered versus their separate administration was demonstrated in terms of rSBA geometric mean titers (GMTs) for 4 meningococcal serogroups and of the percentage of participants with antibody concentrations >1 IU/ml for D and T. Among the pertussis antigens, non-inferiority criteria for geometric mean concentrations (GMCs) were reached for PT, but not met for FHA and PRN. Across all groups, >= 93.2% of participants had vaccine responses to each meningococcal serogroup, >= 99.1% were seroprotected against T and D, and >= 85.5% had booster responses to each pertussis antigen. Robust increases in antibody GMTs/GMCs were observed for all antigens between pre-and post-vaccination. Both vaccines had clinically acceptable safety profiles. Conclusion: Immune responses to MenACWY-TT and to the T and D antigens from Tdap were not impacted by their co-administration. The lower antibody concentrations observed against the pertussis components may be of limited clinical relevance since robust anti-pertussis booster responses were observed. This study supports concurrent administration of the 2 vaccines in adolescents. (C) 2018 GlaxoSmithKline Biologicals SA. Published by Elsevier Ltd. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCI LTD | - |
dc.subject | Y CONJUGATE VACCINE | - |
dc.subject | NEISSERIA-MENINGITIDIS | - |
dc.subject | IMMUNE-RESPONSES | - |
dc.subject | CONTROLLED-TRIAL | - |
dc.subject | W-135 | - |
dc.subject | SEROGROUPS | - |
dc.subject | DISEASE | - |
dc.subject | PERSISTENCE | - |
dc.subject | RECOMMENDATIONS | - |
dc.subject | REACTOGENICITY | - |
dc.title | Immunogenicity and safety of the quadrivalent meningococcal vaccine MenACWY-TT co-administered with a combined diphtheria-tetanus-acellular pertussis vaccine versus their separate administration in adolescents and young adults: A phase III, randomized study | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Yun-Kyung | - |
dc.identifier.doi | 10.1016/j.vaccine.2018.04.034 | - |
dc.identifier.scopusid | 2-s2.0-85048305823 | - |
dc.identifier.wosid | 000439676800021 | - |
dc.identifier.bibliographicCitation | VACCINE, v.36, no.31, pp.4750 - 4758 | - |
dc.relation.isPartOf | VACCINE | - |
dc.citation.title | VACCINE | - |
dc.citation.volume | 36 | - |
dc.citation.number | 31 | - |
dc.citation.startPage | 4750 | - |
dc.citation.endPage | 4758 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Immunology | - |
dc.relation.journalResearchArea | Research & Experimental Medicine | - |
dc.relation.journalWebOfScienceCategory | Immunology | - |
dc.relation.journalWebOfScienceCategory | Medicine, Research & Experimental | - |
dc.subject.keywordPlus | Y CONJUGATE VACCINE | - |
dc.subject.keywordPlus | NEISSERIA-MENINGITIDIS | - |
dc.subject.keywordPlus | IMMUNE-RESPONSES | - |
dc.subject.keywordPlus | CONTROLLED-TRIAL | - |
dc.subject.keywordPlus | W-135 | - |
dc.subject.keywordPlus | SEROGROUPS | - |
dc.subject.keywordPlus | DISEASE | - |
dc.subject.keywordPlus | PERSISTENCE | - |
dc.subject.keywordPlus | RECOMMENDATIONS | - |
dc.subject.keywordPlus | REACTOGENICITY | - |
dc.subject.keywordAuthor | Quadrivalent meningococcal conjugate vaccine | - |
dc.subject.keywordAuthor | Combined diphtheria-tetanus-acellular pertussis vaccine | - |
dc.subject.keywordAuthor | Co-administration | - |
dc.subject.keywordAuthor | Immunogenicity | - |
dc.subject.keywordAuthor | Safety | - |
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