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|Title:||Immunogenicity and safety of a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine 6 years after MenC priming as toddlers|
Van der Wielen, M.
|Citation:||The Pediatric Infectious Disease Journal, 2019; 38(6):643-650|
|Publisher:||Lippincott Williams & Wilkins|
|Terry Nolan, Robert Booy, Helen Marshall, Peter Richmond, Michael Nissen, John Ziegler, Yaela Baine, Magali Traskine, Archana Jastorf, Marie Van der Wielen|
|Abstract:||BACKGROUND:We assessed immunogenicity, antibody persistence and safety of the meningococcal serogroups A, C, W and Y-tetanus toxoid (TT) conjugate vaccine (MenACWY-TT) in children primed as toddlers with MenC vaccine. METHODS:This open, multicenter extension study enrolled children 84-95 months of age who had received one dose of the combined Haemophilus influenzae type b (Hib)-MenC-TT conjugate vaccine (HibMenC group) or Hib-TT and monovalent MenC (MCC)-CRM197 vaccines (Hib+MCC group) at 12-18 months of age, in the primary study. All participants received one dose of MenACWY-TT. We assessed immunogenicity against MenA, MenC, MenW and MenY at 1 month and 2 years postvaccination by serum bactericidal assay using baby rabbit complement (rSBA). Safety and reactogenicity were evaluated. RESULTS:Six years post-MenC vaccination, <20% of children retained rSBA-MenC titers ≥1:8. At 1 month post-MenACWY-TT vaccination, vaccine response rates against all serogroups were high for both groups with ≥97.1% of children having rSBA ≥1:8. Two years postvaccination, ≥63.6% of children retained rSBA-MenA ≥1:8, and ≥87.9% for other serogroups. Geometric mean titers for all serogroups declined at 2 years post-MenACWY-TT vaccination, but remained ≥13 times higher than prevaccination levels. For both groups, pain (≤58.5%), redness (≤51.4%) and fatigue (≤27.0%) were the most frequently reported adverse events. No serious adverse events were reported. CONCLUSIONS:One dose of MenACWY-TT boosts protection against MenC in primed children, is safe and extends protection against MenA, MenW and MenY. Immunogenicity and safety were comparable in infants vaccinated with conjugated vaccine (HibMenC-TT) or the separate vaccines (Hib-TT and MCC-CRM197).|
|Keywords:||Quadrivalent meningococcal vaccine; children; bactericidal activity; persistence; safety|
|Rights:||© 2019 The Author(s). Published by Wolters Kluwer Health, Inc.|
|Appears in Collections:||Paediatrics publications|
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