{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T12:07:16Z","timestamp":1792670836092,"version":"4.5.0"},"reference-count":48,"publisher":"Springer Science and Business Media LLC","license":[{"start":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T00:00:00Z","timestamp":1772755200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T00:00:00Z","timestamp":1772755200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Pediatr Res"],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>A quadrivalent meningococcal tetanus toxoid-conjugate vaccine, MenACYW-TT, was developed to provide broad protection against invasive meningococcal disease across all age groups. We evaluated the immunogenicity and safety of MenACYW-TT as a two-dose series (1\u2009+\u20091 schedule) co-administered with routine pediatric vaccines to infants from 6 months of age.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      This phase III modified double-blind, randomized study (NCT03691610) enrolled healthy infants (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009750) and toddlers (\n                      <jats:italic>n<\/jats:italic>\n                      \u2009=\u2009200). Infants were randomized 1:1 to receive MenACYW-TT (Group 1) or another quadrivalent conjugate vaccine, MenACWY-CRM (Group 2) at ages 6\u20137 and 12\u201313 months, co-administered with routine vaccines. Toddlers were randomized 1:1 to receive MenACYW-TT (Group 3) or another quadrivalent conjugate vaccine, MenACWY-DT (Group 4) at ages 17\u201319 and 20\u201323 months. Functional antibodies against the four meningococcal serogroups were assessed by serum bactericidal antibody assay using human complement (hSBA). Safety was assessed up to 6 months post-vaccination.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Seroresponse to MenACYW-TT was non-inferior to that with MenACWY-CRM against all four serogroups (seroresponse rates 30 days post-dose 2 were 89.4\u201399.3% and 82.9\u201397.7%, respectively). All vaccines were well tolerated.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>These findings support MenACYW-TT administration as a two-dose series in children from 6 months of age.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Study registration<\/jats:title>\n                    <jats:p>Clinicaltrials.gov: NCT03691610.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Impact<\/jats:title>\n                    <jats:p>\n                      <jats:list list-type=\"bullet\">\n                        <jats:list-item>\n                          <jats:p>When administered as a two-dose series (1\u2009+\u20091 schedule), MenACYW-TT demonstrated comparable\/higher immunogenicity to MenACWY-CRM (ages 6\u20137 and 12\u201313 months) and the safety profiles of these quadrivalent meningococcal vaccines were similar.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>MenACYW-TT was non-inferior to MenACWY-CRM in terms of seroresponse rates and proportion of participants with antibody titer \u22651:8 after a second dose at age 12\u201313 months.<\/jats:p>\n                        <\/jats:list-item>\n                        <jats:list-item>\n                          <jats:p>This phase III study is the first to confirm the safety and immunogenicity of MenACYW-TT in infants and supports its use as a two-dose series from 6 months of age.<\/jats:p>\n                        <\/jats:list-item>\n                      <\/jats:list>\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1038\/s41390-026-04833-8","type":"journal-article","created":{"date-parts":[[2026,3,6]],"date-time":"2026-03-06T15:59:01Z","timestamp":1772812741000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Meningococcal quadrivalent ACYW-TT conjugated vaccine at 6\u201323 months: phase III study (US\/Puerto Rico)"],"prefix":"10.1038","author":[{"given":"Cheryl","family":"Duffy","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Lyabis","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mandeep Singh","family":"Dhingra","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Betzana","family":"Zambrano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Chaix","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Syrkina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Siham","family":"B\u2019Chir","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandeep","family":"Gupta","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine","family":"Rehm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2026,3,6]]},"reference":[{"key":"4833_CR1","unstructured":"European Centre for Disease Prevention and Control. Factsheet about meningococcal disease (accessed 5 September 2024); https:\/\/www.ecdc.europa.eu\/en\/meningococcal-disease\/factsheet#:~:text=The."},{"key":"4833_CR2","unstructured":"US Centers for Disease Control and Prevention. About meningococcal disease (accessed 5 September 2024); https:\/\/www.cdc.gov\/meningococcal\/about\/index.html."},{"key":"4833_CR3","unstructured":"World Health Organization. Fact sheet: Meningitis (accessed 5 September 2024); https:\/\/www.who.int\/news-room\/fact-sheets\/detail\/meningitis."},{"key":"4833_CR4","doi-asserted-by":"publisher","first-page":"e57","DOI":"10.1017\/S0950268823000328","volume":"151","author":"C Pardo de Santayana","year":"2023","unstructured":"Pardo de Santayana, C., Tin Tin Htar, M., Findlow, J. & Balmer, P. Epidemiology of invasive meningococcal disease worldwide from 2010-2019: a literature review. Epidemiol. Infect. 151, e57 (2023).","journal-title":"Epidemiol. Infect."},{"key":"4833_CR5","unstructured":"World Health Organization. Health Topics: Meningitis (accessed 3 February 2025); https:\/\/www.who.int\/health-topics\/meningitis#tab=tab_2."},{"key":"4833_CR6","doi-asserted-by":"publisher","first-page":"421","DOI":"10.1007\/s40121-018-0213-2","volume":"7","author":"KJ Olbrich","year":"2018","unstructured":"Olbrich, K. J. et al. Systematic review of invasive meningococcal disease: sequelae and quality of life impact on patients and their caregivers. Infect. Dis. Ther. 7, 421\u2013438 (2018).","journal-title":"Infect. Dis. Ther."},{"key":"4833_CR7","unstructured":"US Centers for Disease Control and Prevention. Meningococcal disease surveillance and trends (accessed 5 September 2024); https:\/\/www.cdc.gov\/meningococcal\/php\/surveillance\/index.html."},{"key":"4833_CR8","doi-asserted-by":"publisher","first-page":"2034","DOI":"10.1016\/j.vaccine.2017.03.007","volume":"35","author":"R Whittaker","year":"2017","unstructured":"Whittaker, R. et al. The epidemiology of invasive meningococcal disease in EU\/EEA countries, 2004-2014. Vaccine 35, 2034\u20132041 (2017).","journal-title":"Vaccine"},{"key":"4833_CR9","unstructured":"Australian Government - Department of Health and Aged Care. Meningococcal disease: the Australian Immunisation Handbook (accessed 5 September 2024); https:\/\/immunisationhandbook.health.gov.au\/contents\/vaccine-preventable-diseases\/meningococcal-disease#infants-and-children."},{"key":"4833_CR10","unstructured":"European Centre for Disease Prevention and Control. Meningococcal disease: recommended vaccinations (accessed 5 September 2024); https:\/\/vaccine-schedule.ecdc.europa.eu\/Scheduler\/ByDisease?SelectedDiseaseId=48&SelectedCountryIdByDisease=-1."},{"key":"4833_CR11","unstructured":"Government of Canada. Meningococcal vaccines: Canadian immunization guide (accessed 5 September 2024); https:\/\/www.canada.ca\/en\/public-health\/services\/publications\/healthy-living\/canadian-immunization-guide-part-4-active-vaccines\/page-13-meningococcal-vaccine.html."},{"key":"4833_CR12","doi-asserted-by":"publisher","first-page":"1","DOI":"10.15585\/mmwr.rr6909a1","volume":"69","author":"SA Mbaeyi","year":"2020","unstructured":"Mbaeyi, S. A. et al. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm. Rep. 69, 1\u201341 (2020).","journal-title":"MMWR Recomm. Rep."},{"key":"4833_CR13","unstructured":"World Health Organization. Immunization, vaccines and biologicals. Meningococcal meningitis (accessed 5 September 2024); https:\/\/www.who.int\/teams\/immunization-vaccines-and-biologicals\/diseases\/meningitis."},{"key":"4833_CR14","unstructured":"US Food and Drug Administration. MenQuadfi. Highlights of prescribing information. (accessed 1 December 2025); https:\/\/www.fda.gov\/media\/137306\/download."},{"key":"4833_CR15","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268821000698","volume":"149","author":"MS Dhingra","year":"2021","unstructured":"Dhingra, M. S. et al. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine administered concomitantly with other paediatric vaccines in toddlers: a phase III randomised study. Epidemiol. Infect. 149, e90 (2021).","journal-title":"Epidemiol. Infect."},{"key":"4833_CR16","doi-asserted-by":"publisher","first-page":"2052657","DOI":"10.1080\/21645515.2022.2052657","volume":"18","author":"M Knuf","year":"2022","unstructured":"Knuf, M. et al. Comparing the meningococcal serogroup C immune response elicited by a tetanus toxoid conjugate quadrivalent meningococcal vaccine (MenACYW-TT) versus a quadrivalent or monovalent C tetanus toxoid conjugate meningococcal vaccine in healthy meningococcal vaccine-naive toddlers: a randomised, controlled trial. Hum. Vaccin. Immunother. 18, 2052657 (2022).","journal-title":"Hum. Vaccin. Immunother."},{"key":"4833_CR17","doi-asserted-by":"publisher","DOI":"10.1017\/S0950268821000261","volume":"149","author":"D van der Vliet","year":"2021","unstructured":"van der Vliet, D. et al. 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-naive and meningococcal C conjugate vaccine-primed toddlers: a phase III randomised study. Epidemiol. Infect. 149, e50 (2021).","journal-title":"Epidemiol. 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Vaccine 38, 3560\u20133569 (2020).","journal-title":"Vaccine"},{"key":"4833_CR22","doi-asserted-by":"publisher","first-page":"5194","DOI":"10.1016\/j.vaccine.2020.06.013","volume":"38","author":"MS Dhingra","year":"2020","unstructured":"Dhingra, M. S. et al. Immunogenicity, safety and inter-lot consistency of a meningococcal conjugate vaccine (MenACYW-TT) in adolescents and adults: a phase III randomized study. Vaccine 38, 5194\u20135201 (2020).","journal-title":"Vaccine"},{"key":"4833_CR23","doi-asserted-by":"publisher","first-page":"1835","DOI":"10.1007\/s40121-024-01009-x","volume":"13","author":"J Diez-Domingo","year":"2024","unstructured":"Diez-Domingo, J. et al. Immunogenicity and safety of a quadrivalent meningococcal conjugate vaccine versus Nimenrix in healthy adolescents: a randomized phase IIIb multicenter study. Infect. Dis. Ther. 13, 1835\u20131859 (2024).","journal-title":"Infect. Dis. 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Immunother."},{"key":"4833_CR26","doi-asserted-by":"publisher","first-page":"174","DOI":"10.7883\/yoken.JJID.2022.272","volume":"76","author":"O Matsuoka","year":"2023","unstructured":"Matsuoka, O. et al. Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in meningococcal vaccine-naive participants across a broad age range (2-55 Years) in Japan: a phase III randomized study. Jpn. J. Infect. Dis. 76, 174\u2013182 (2023).","journal-title":"Jpn. J. Infect. Dis."},{"key":"4833_CR27","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1080\/21645515.2021.1902701","volume":"18","author":"FM Piazza","year":"2022","unstructured":"Piazza, F. M. et al. Immunogenicity and safety of an investigational quadrivalent meningococcal conjugate vaccine administered as a booster dose in children vaccinated against meningococcal disease 3 years earlier as toddlers: a phase III, open-label, multi-center study. Hum. Vaccin. 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Immunother."},{"key":"4833_CR32","unstructured":"Australian Government Therapeutic Goods Administration. Australian product information \u2013 MENQUADFI\u00ae (meningococcal (groups A, C, Y, W) polysaccharide tetanus toxoid conjugate vaccine) solution for injection (5 September accessed 2024); https:\/\/www.tga.gov.au\/sites\/default\/files\/auspar-meningococcal-groups-a-c-y-w-polysaccharide-tetanus-toxoid-conjugate-vaccine-210317-pi.pdf."},{"key":"4833_CR33","unstructured":"European Medicines Agency. MenQuadfi solution for injection. Summary of product characteristics (accessed 5 September 2024); https:\/\/ec.europa.eu\/health\/documents\/community-register\/2022\/20220929157200\/anx_157200_en.pdf."},{"key":"4833_CR34","unstructured":"Government of Canada - Health Canada. MenQuadfi. Meningococcal (groups A, C, Y, W) polysaccharide tetanus toxoid conjugate vaccine solution for injection. Product monograph. 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S.B., S.G., and C.R. are employees of Sanofi and may hold stocks\/shares. M.S.D. and B.Z. were employees of Sanofi at the time of the study and may hold stocks\/shares. C. D. has no competing interests to disclose.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"An informed consent form was signed by the parents\/guardians of each study participant before any study-related treatment or procedure was performed. This study was approved by the Institutional Review Board for all sites and all investigators, Advarra, Columbus, MD.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}}]}}