{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T07:32:59Z","timestamp":1792740779855,"version":"4.5.0"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"11","license":[{"start":{"date-parts":[[2024,10,30]],"date-time":"2024-10-30T00:00:00Z","timestamp":1730246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,10,30]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>Meningococcal serogroup B (MenB) strains are highly diverse. Breadth of immune response for the MenB vaccine, 4CMenB, administered at 0\u20132, 0\u20136, or 0\u20132\u20136 months, was demonstrated by endogenous complement-human serum bactericidal antibody (enc-hSBA) assay against an epidemiologically relevant panel of 110 MenB strains.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In a phase 3 trial, 3651 healthy 10- to 25-year-old participants were randomized 5:5:9:1 to receive 4CMenB (0\u20136 schedule), 4CMenB (0\u20132\u20136 schedule), investigational MenABCWY vaccine, or control MenACWY-CRM vaccine. The primary objectives were to evaluate safety and demonstrate breadth of immune response by enc-hSBA assay against the MenB strain panel using test-based (percentage of samples without bactericidal activity against strains after 4CMenB vs control vaccination) and responder-based (percentage of participants whose postvaccination sera kill \u226570% strains) approaches. Success was demonstrated with 2-sided 97.5% confidence interval (CI) lower limit &amp;gt;65%. Immunogenicity was assessed by traditional hSBA assay against four indicator strains.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Breadth of immune response (test-based) was 78.7% (97.5% CI, 77.2\u201380.1), 81.8% (80.4\u201383.1), 83.2% (81.9\u201384.4) for the 0\u20132, 0\u20136, and 0\u20132\u20136 schedules, respectively, and (responder-based) 84.8% (81.8\u201387.5), 89.8% (87.2\u201392.0), and 93.4% (91.2\u201395.2), respectively. No clinically relevant differences in immunogenicity were observed across schedules. 4CMenB was well tolerated.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The 2-dose (0\u20132, 0\u20136) 4CMenB schedules met predefined criteria for success for both breadth of immune response endpoints against a diverse MenB strain panel, had comparable immunogenicity, and safety in line with the established 4CMenB safety profile. The 3-dose schedule provided no additional immunological benefit, supporting use of the 4CMenB 0\u20132 schedule.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ofid\/ofae638","type":"journal-article","created":{"date-parts":[[2024,10,31]],"date-time":"2024-10-31T08:39:59Z","timestamp":1730363999000},"source":"Crossref","is-referenced-by-count":9,"title":["4CMenB Breadth of Immune Response, Immunogenicity, and Safety: Results From a Phase 3 Randomized, Controlled, Observer Blind Study in Adolescents and Young Adults"],"prefix":"10.1093","volume":"11","author":[{"given":"Terry","family":"Nolan","sequence":"first","affiliation":[{"name":"Vaccine and Immunisation Research Group, Peter Doherty Institute at the University of Melbourne, and Murdoch Children's Research Institute , Melbourne, Victoria ,","place":["Australia"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiranjiwi","family":"Bhusal","sequence":"additional","affiliation":[{"name":"GSK , Amsterdam 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