Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) vs . a licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine in meningococcal vaccine-naïve and meningococcal C conjugate vaccine-primed toddlers: a phase III randomised study.

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Tytuł:: Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) vs . a licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine in meningococcal vaccine-naïve and meningococcal C conjugate vaccine-primed toddlers: a phase III randomised study.
Autorzy:: van der Vliet D; Sanofi Pasteur, Marcy l'Etoile, France.
Vesikari T; Vaccine Research Center, University of Tampere, Tampere, Finland.
Sandner B; NETSTAP (Network of children's physicians for clinical trials in the ambulant pediatrics), Aschaffenburg, Germany.
Martinón-Torres F; Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela, Santiago de Compostela, Spain.; Genetics, Vaccines and Pediatrics Research Group, University of Santiago de Compostela, Instituto de Investigación Sanitaria de Santiago de Compostela, Santiago de Compostela, Spain.
Muzsay G; Gyor-Marcal Város II. sz. Gyermekorvosi Rendelő, Pediatrics, Győr, Hungary.
Forsten A; Vaccine Research Center, University of Tampere, Tampere, Finland.
Adelt T; Pediatric practice, Bramsche, in cooperation with NETSTAP (Network of Children's Physicians for clinical trials in the ambulant pediatrics), Germany.
Diaz Gonzalez C; Hospital Universitario La Paz, Madrid, Spain.
Simko R; Futurenest Clinical Research, Miskolc, Hungary.
B'Chir S; Sanofi Pasteur, Marcy l'Etoile, France.
Neveu D; Sanofi Pasteur, Swiftwater, PA, USA.
Jordanov E; Sanofi Pasteur, Swiftwater, PA, USA.
Dhingra MS; Sanofi Pasteur, Swiftwater, PA, USA.
Źródło:: Epidemiology and infection [Epidemiol Infect] 2021 Feb 05; Vol. 149, pp. e50. Date of Electronic Publication: 2021 Feb 05.
Typ publikacji:: Clinical Trial, Phase III; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
Język:: English
Imprint Name(s):: Original Publication: Cambridge Eng : Cambridge University Press
MeSH Terms:: Meningococcal Vaccines/*immunology
Tetanus Toxoid/*immunology
Europe ; Female ; Finland ; Humans ; Infant ; Male ; Meningococcal Infections/prevention & control ; Meningococcal Vaccines/administration & dosage ; Tetanus/prevention & control ; Tetanus Toxoid/administration & dosage ; Vaccines, Combined
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Contributed Indexing:: Keywords: IMD; MenACYW-TT; quadrivalent meningococcal vaccine; toddlers
Substance Nomenclature:: 0 (Meningococcal Vaccines)
0 (Tetanus Toxoid)
0 (Vaccines, Combined)
0 (serogroup C meningococcal conjugate vaccine)
Entry Date(s):: Date Created: 20210205 Date Completed: 20210420 Latest Revision: 20210507
Update Code:: 20240104
PubMed Central ID:: PMC8060839
DOI:: 10.1017/S0950268821000261
PMID:: 33541457
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Vaccination remains the best strategy to reduce invasive meningococcal disease. This study evaluated an investigational tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MenACYW-TT) vs. a licensed tetanus toxoid-conjugate quadrivalent meningococcal vaccine (MCV4-TT) (NCT02955797). Healthy toddlers aged 12-23 months were included if they were either meningococcal vaccine-naïve or MenC conjugate (MCC) vaccine-primed (≥1 dose of MCC prior to 12 months of age). Vaccine-naïve participants were randomised 1:1 to either MenACYW-TT (n = 306) or MCV4-TT (n = 306). MCC-primed participants were randomised 2:1 to MenACYW-TT (n = 203) or MCV4-TT (n = 103). Antibody titres against each of the four meningococcal serogroups were measured by serum bactericidal antibody assay using the human complement. The co-primary objectives of this study were to demonstrate the non-inferiority of MenACYW-TT to MCV4-TT in terms of seroprotection (titres ≥1:8) at Day 30 in both vaccine-naïve and all participants (vaccine-naïve and MCC-primed groups pooled). The immune response for all four serogroups to MenACYW-TT was non-inferior to MCV4-TT in vaccine-naïve participants (seroprotection: range 83.6-99.3% and 81.4-91.6%, respectively) and all participants (seroprotection: range 83.6-99.3% and 81.4-98.0%, respectively). The safety profiles of both vaccines were comparable. MenACYW-TT was well-tolerated and demonstrated non-inferior immunogenicity when administered to MCC vaccine-primed and vaccine-naïve toddlers.

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