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- Title
Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) . a licensed quadrivalent meningococcal tetanus toxoid-conjugate vaccine in meningococcal vaccine-naïve and meningococcal C conjugate vaccine-primed toddlers: a phase III randomised study.
- Authors
van der Vliet, D.; Vesikari, T.; Sandner, B.; Martinón-Torres, F.; Muzsay, G.; Forsten, A.; Adelt, T.; Diaz Gonzalez, C.; Simko, R.; B'Chir, S.; Neveu, D.; Jordanov, E.; Dhingra, M. S.
- Abstract
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.
- Subjects
EUROPE; FINLAND; TETANUS; RESEARCH; CLINICAL trials; RESEARCH methodology; MEDICAL cooperation; EVALUATION research; MENINGOCOCCAL vaccines; COMBINED vaccines; COMPARATIVE studies; RANDOMIZED controlled trials; TETANUS vaccines; NEISSERIA meningitidis
- Publication
Epidemiology & Infection, 2021, Vol 149, p1
- ISSN
0950-2688
- Publication type
journal article
- DOI
10.1017/S0950268821000261