Trial reportHuman vaccines & immunotherapeutics2025
Safety and immunogenicity of a 3-dose schedule of a quadrivalent meningococcal tetanus toxoid conjugate vaccine administered concomitantly with routine pediatric vaccines to infants and toddlers: A descriptive randomized study.
Trial report in Human vaccines & immunotherapeutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03630705 (Safety and Immunogenicity of a 3-Dose Schedule of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers), which is not on this map. Not yet cited in PubMed.
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Safety and Immunogenicity of a 3-Dose Schedule of an Investigational Quadrivalent Meningococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers
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9 authors.
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Abstract
MenACYW-TT (MenQuadfi®), a quadrivalent meningococcal conjugate vaccine, is approved for use in individuals aged ≥12 months or ≥6 weeks depending on the country. This study reported the immunogenicity and safety of MenACYW-TT in individuals aged <12 months. This phase III, open-label, randomized, active-controlled study described the immunogenicity and safety of a 3-dose (2 + 1) immunization schedule of MenACYW-TT in Mexico and the Russian Federation or a 4-dose (3 + 1) immunization schedule of MCV4-CRM in Mexico, when co-administered with routine pediatric vaccines to healthy infants and toddlers aged 2 to 12 months (NCT03630705). The immunogenicity of meningococcal serogroups was assessed by serum bactericidal antibody assays using human complement. The safety data were collected for up to 30 d following vaccination. MenACYW-TT demonstrated high seroprotection rates in Mexico and in the Russian Federation after the last vaccination (booster) at 12 months of age. The proportion of participants achieving seroresponse to all 4 meningococcal serogroups after receiving 2 doses of MenACYW-TT in the infant series was comparable to the proportion of those receiving 3 doses of MCV4-CRM in Mexico. There was no clinically relevant effect on the immunogenicity and safety profile of the routine pediatric vaccines when administered concomitantly with MenACYW-TT at the same visit. No safety concern was observed during this study. MenACYW-TT demonstrated a safety profile generally comparable with that of MCV4-CRM when administered concomitantly with routine pediatric vaccines. The MenACYW-TT conjugate vaccine in a 2 + 1 schedule demonstrated an acceptable immunogenicity and safety profile.
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