Full metadata record
DC Field | Value | Language |
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dc.contributor.author | 김경효 | * |
dc.date.accessioned | 2018-12-14T16:30:48Z | - |
dc.date.available | 2018-12-14T16:30:48Z | - |
dc.date.issued | 2018 | * |
dc.identifier.issn | 0264-410X | * |
dc.identifier.other | OAK-22663 | * |
dc.identifier.uri | https://dspace.ewha.ac.kr/handle/2015.oak/247705 | - |
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), MenACWY-TT at Month 0 and Tdap at Month 1 (ACWY_Tdap group) or Tdap at Month 0 and MenACWY-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. © 2018 GlaxoSmithKline Biologicals SA | * |
dc.language | English | * |
dc.publisher | Elsevier Ltd | * |
dc.subject | Co-administration | * |
dc.subject | Combined diphtheria-tetanus-acellular pertussis vaccine | * |
dc.subject | Immunogenicity | * |
dc.subject | Quadrivalent meningococcal conjugate vaccine | * |
dc.subject | Safety | * |
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.relation.issue | 31 | * |
dc.relation.volume | 36 | * |
dc.relation.index | SCIE | * |
dc.relation.index | SCOPUS | * |
dc.relation.startpage | 4750 | * |
dc.relation.lastpage | 4758 | * |
dc.relation.journaltitle | Vaccine | * |
dc.identifier.doi | 10.1016/j.vaccine.2018.04.034 | * |
dc.identifier.wosid | WOS:000439676800021 | * |
dc.identifier.scopusid | 2-s2.0-85048305823 | * |
dc.author.google | Rivera L. | * |
dc.author.google | Schwarz T.F. | * |
dc.author.google | Kim K.-H. | * |
dc.author.google | Kim Y.-K. | * |
dc.author.google | Behre U. | * |
dc.author.google | Cha S.-H. | * |
dc.author.google | Jo D.S. | * |
dc.author.google | Lee J. | * |
dc.author.google | Lee J.-S. | * |
dc.author.google | Cheuvart B. | * |
dc.author.google | Jastorff A. | * |
dc.author.google | Van der Wielen M. | * |
dc.contributor.scopusid | 김경효(35448653000) | * |
dc.date.modifydate | 20240301081003 | * |