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
| Autor: | B. Sandner, Timo Vesikari, R. Simko, T. Adelt, C. Diaz Gonzalez, D. van der Vliet, David Neveu, Emilia Jordanov, Aino Forsten, Federico Martinón-Torres, Mandeep S. Dhingra, G. Muzsay, Siham B’Chir |
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| Rok vydání: | 2021 |
| Předmět: |
0301 basic medicine
Epidemiology Tetanus business.industry Immunogenicity 030106 microbiology Toxoid Antibody titer Meningococcal vaccine medicine.disease Vaccination 03 medical and health sciences Serum Bactericidal Antibody Assay 0302 clinical medicine Infectious Diseases Conjugate vaccine Immunology medicine 030212 general & internal medicine business |
| Zdroj: | Epidemiology and Infection. 149 |
| ISSN: | 1469-4409 0950-2688 |
| DOI: | 10.1017/s0950268821000261 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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