{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T06:20:11Z","timestamp":1791872411070,"version":"4.3.4"},"reference-count":24,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"10","license":[{"start":{"date-parts":[[2020,8,21]],"date-time":"2020-08-21T00:00:00Z","timestamp":1597968000000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2020,10]]},"abstract":"<jats:sec>\n            <jats:title>Background:<\/jats:title>\n            <jats:p>Invasive meningococcal disease is a major cause of meningitis in children. An investigational meningococcal (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine (MenACYW-TT) could offer protection against invasive meningococcal disease in this population. This phase III study assessed the immunogenicity and safety of MenACYW-TT in children compared with a licensed quadrivalent meningococcal vaccine conjugated with diphtheria protein CRM<jats:sub>197<\/jats:sub> (MenACWY-CRM).<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods:<\/jats:title>\n            <jats:p>Healthy children 2\u20139 years of age in the United States, including Puerto Rico, were randomized (1:1) to receive MenACYW-TT (n = 499) or MenACWY-CRM (n = 501) (NCT03077438). Meningococcal antibody titers to the 4 vaccine serogroups were measured using a serum bactericidal antibody assay with human complement (hSBA) before and at day 30 after vaccination. Noninferiority between the vaccine groups was assessed by comparing seroresponse rates (postvaccination titers \u22651:16 when prevaccination titers were &lt;1:8, or \u22654-fold increase if prevaccination titers were \u22651:8) to the 4 serogroups at day 30. Safety was monitored.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results:<\/jats:title>\n            <jats:p>The proportion of participants achieving seroresponse at day 30 in the MenACYW-TT group was noninferior to the MenACWY-CRM group (A: 55.4% vs. 47.8%; C: 95.2% vs. 47.8%; W: 78.8% vs. 64.1%; Y: 91.5% vs. 79.3%, respectively). Geometric mean titers for serogroups C, W, and Y were higher with MenACYW-TT than for MenACWY-CRM. Both vaccines were well-tolerated and had similar safety profiles.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions:<\/jats:title>\n            <jats:p>MenACYW-TT was well-tolerated in children and achieved noninferior immune responses to MenACWY-CRM against each of the 4 vaccine serogroups.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1097\/inf.0000000000002832","type":"journal-article","created":{"date-parts":[[2020,8,27]],"date-time":"2020-08-27T03:02:47Z","timestamp":1598497367000},"page":"955-960","source":"Crossref","is-referenced-by-count":28,"title":["Safety and Immunogenicity of a Quadrivalent Meningococcal Conjugate Vaccine in Healthy Meningococcal-Na\u00efve Children 2\u20139 Years of Age: A Phase III, Randomized Study"],"prefix":"10.1097","volume":"39","author":[{"given":"Carmen I.","family":"Baccarini","sequence":"first","affiliation":[{"name":"Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael W.","family":"Simon","sequence":"additional","affiliation":[{"name":"Baptist Health, Nicholasville, KT"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donald","family":"Brandon","sequence":"additional","affiliation":[{"name":"California Research Foundation, San Diego, CA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shane","family":"Christensen","sequence":"additional","affiliation":[{"name":"Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emilia","family":"Jordanov","sequence":"additional","affiliation":[{"name":"Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mandeep S.","family":"Dhingra","sequence":"additional","affiliation":[{"name":"Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2020,8,21]]},"reference":[{"key":"R1-20230912","doi-asserted-by":"crossref","first-page":"421","DOI":"10.1007\/s40121-018-0213-2","article-title":"Systematic review of invasive meningococcal disease: sequelae and quality of life impact on patients and their caregivers.","volume":"7","author":"Olbrich","year":"2018","journal-title":"Infect Dis Ther"},{"key":"R2-20230912","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1080\/14760584.2019.1557520","article-title":"The Global Meningococcal Initiative meeting on prevention of meningococcal disease worldwide: epidemiology, surveillance, hypervirulent strains, antibiotic resistance and high-risk populations.","volume":"18","author":"Acevedo","year":"2019","journal-title":"Expert Rev Vaccines"},{"key":"R3-20230912","doi-asserted-by":"crossref","first-page":"321","DOI":"10.3389\/fped.2018.00321","article-title":"Invasive meningococcal disease in the vaccine era.","volume":"6","author":"Nadel","year":"2018","journal-title":"Front Pediatr"},{"key":"R6-20230912","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1186\/1478-7954-11-17","article-title":"Global epidemiology of invasive meningococcal disease.","volume":"11","author":"Jafri","year":"2013","journal-title":"Popul Health Metr"},{"key":"R8-20230912","doi-asserted-by":"crossref","first-page":"010409","DOI":"10.7189\/jogh.09.010409","article-title":"Meningococcal serogroups and surveillance: a systematic review and survey.","volume":"9","author":"Peterson","year":"2019","journal-title":"J Glob Health"},{"key":"R11-20230912","doi-asserted-by":"crossref","first-page":"1084","DOI":"10.1080\/21645515.2018.1434463","article-title":"Challenges and opportunities for meningococcal vaccination in the developing world.","volume":"14","author":"Shaker","year":"2018","journal-title":"Hum Vaccin Immunother"},{"key":"R13-20230912","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1128\/cdli.4.2.156-167.1997","article-title":"Standardization and a multilaboratory comparison of Neisseria meningitidis serogroup A and C serum bactericidal assays. 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