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This phase III, open-label, randomized, active-controlled study evaluated immunogenicity and safety of a 3-dose (2+1) schedule in Mexico and the Russian Federation, compared with a 4-dose (3+1) MCV4-CRM regimen in Mexico, when co-administered with routine pediatric vaccines to 2–12-month infants and toddlers. Serum bactericidal antibody assays and safety follow-up up to 30 days showed high seroprotection, comparable seroresponse across relevant groups, no clinically relevant impact on routine vaccine immunogenicity, and no safety concern.",{"@graph":69,"@context":122},[70,84,105],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/safety-and-immunogenicity-of-a-3-dose-schedule-of-a-quadrivalent-meningococcal-tetanus-toxoid-conjugate-vaccine-a-descriptive-randomized-study/440616/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/safety-and-immunogenicity-of-a-3-dose-schedule-of-a-quadrivalent-meningococcal-tetanus-toxoid-conjugate-vaccine-a-descriptive-randomized-study/440616.png","ImageObject",300,407,{"name":92,"@type":93},"acoobca","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-01","2026-09-29",true,{"@type":102,"interactionType":103,"userInteractionCount":8},"InteractionCounter",{"@type":104},"ViewAction",{"@type":106,"mainEntity":107},"FAQPage",[108,114,118],{"name":109,"@type":110,"acceptedAnswer":111},"What was the study designed to evaluate?","Question",{"text":112,"@type":113},"The study assessed the immunogenicity and safety of MenACYW-TT given as a 3-dose (2+1) schedule, including when co-administered with routine pediatric vaccines.","Answer",{"name":115,"@type":110,"acceptedAnswer":116},"How were immune responses measured?",{"text":117,"@type":113},"Meningococcal serogroup immunogenicity was assessed using serum bactericidal antibody assays with human complement.",{"name":119,"@type":110,"acceptedAnswer":120},"Did co-administration affect the safety or immunogenicity of routine pediatric vaccines?",{"text":121,"@type":113},"No clinically relevant effect on the immunogenicity and safety profile of routine pediatric vaccines was observed when administered concomitantly with MenACYW-TT, and no safety concern was identified.","https://schema.org",{"og:url":83,"og:type":124,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":126,"canonical":83},"index,follow",{"doc_id":128,"site_id":62},440616,1790814673,{"code":4,"msg":5,"data":131},{"doc_id":128,"user_id":132,"nickname":92,"user_avatar":133,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":134,"file_id":135,"file_url":136,"file_type":137,"file_size":138,"view_count":8,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":139,"language":140,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":141,"faqs":142,"seo_title":143,"seo_description":67,"update_tm":144,"read_time":145},3985747870733,"https://ap-avatar.wpscdn.com/davatar_a8503ba1806abce46bf441b54a3ca4cd","HUMAN VACCINES & IMMUNOTHERAPEUTICS 2025, VOL. 21, NO. 1, 2601413 [https://doi.org/10.1080/21645515.2025.2601413](https://doi.org/10.1080/21645515.2025.2601413)  \nRESEARCH ARTICLE     \nSafety 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:  \nA descriptive randomized study  \nSandra Villagomez-Martineza, Susanna Kharitb, Anna Galustyanc, Betzana Zambranod*,  \nMandeep Singh Dhingrae*, Siham B’Chirf, Olga Syrkinag, Olga Lyabis h, and Christine Rehme  \naCentro de Investigación-Instituto Nacional de Pediatría, Morelos, Mexico; bVaccinology Department, Federal State Budgetary Institution “Children’s Scientific and Clinical Center for Infectious Diseases of the Federal Medical and Biological Agency,”  \nSt. Petersburg, Russian Federation; cLLC “Medical Technologies,” and Saint Petersburg Pediatric Medical University, St. Petersburg, Russian Federation; dGlobal Clinical Development Strategy, Sanofi, Montevideo, Uruguay; eGlobal Clinical Development Strategy, Sanofi, Swiftwater, PA, USA; fGlobal Biostatistical Sciences, Sanofi, Marcy-l’Étoile, France; gGlobal Patient Safety and Pharmacovigilance, Sanofi R&D, Cambridge, MA, USA; hGlobal Clinical Development Strategy, Sanofi, Marcy L’Étoile, France  \nABSTRACT  \nMenACYW-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 \u003C12 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 meningococcalserogroups 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 ina 2 + 1 schedule demonstrated an acceptable immunogenicity and safety profile.  \nARTICLE HISTORY  \nReceived 10 July 2025 Revised 25 November 2025 Accepted 3 December 2025  \nKEYWORDS  \nQuadrivalent meningococcal conjugate vaccine;  \nco-administration;  \nMenACYW-TT;  \nimmunogenicity; safety; pediatric vaccines; toddlers; infants  \nIntroduction  \nInvasive meningococcal disease (IMD) is a serious illness caused by the bacterium Neisseria meningitidis, a Gram-negative diplococcus found exclusively in humans.1 The epidemiology of N. meningitidis can be described as complex, unpredictable, geographically variable, and changing over time.2 There are 12 identified meningococcal serogroups: A, B, C, E, H, I, K, L, W, X, Y, and Z. Historically, 6 of these serogroups (A, B, C, W, Y, and X) are pathogenic and account for meningococcal disease worldwide in both endemic and epidemic forms with seasonal variations.2–4 IMD progresses rapidly and can cause death within 24 h of the onset.4,5 Overall, the case fatality r","cbCaihB8lG7e21To","https://ap.wps.com/l/cbCaihB8lG7e21To","pdf",1329566,18,"English","# Abstract\n# Introduction\n## Invasive meningococcal disease background\n## Serogroups and epidemiology","[{\"question\":\"What was the study designed to evaluate?\",\"answer\":\"The study assessed the immunogenicity and safety of MenACYW-TT given as a 3-dose (2+1) schedule, including when co-administered with routine pediatric vaccines.\"},{\"question\":\"How were immune responses measured?\",\"answer\":\"Meningococcal serogroup immunogenicity was assessed using serum bactericidal antibody assays with human complement.\"},{\"question\":\"Did co-administration affect the safety or immunogenicity of routine pediatric vaccines?\",\"answer\":\"No clinically relevant effect on the immunogenicity and safety profile of routine pediatric vaccines was observed when administered concomitantly with MenACYW-TT, and no safety concern was identified.\"}]","Safety and immunogenicity of a 3-dose schedule of a quadrivalent meningococcal tetanus toxoid conjugate vaccine - A descriptive randomized study | PDF",1790692702,45]