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In this open-label phase III study (NCT03632720; registered 13\/8\/2018), infants were randomised to quadrivalent ACWY conjugated vaccine, MenACYW-TT, at 3 and 12\u201313 months and four-component meningococcus group B vaccine (4CMenB) at 2, 4, and 12\u201313 months (Group 1), MenACYW-TT at 3 and 12\u201313 months and 4CMenB at 2 and 4 months (Group 2), or 4CMenB at 2, 4, and 12\u201313 months (Group 3). Routine vaccines were also administered per UK schedule. Primary outcome of non-inferiority of seroprotection rates against the four capsular groups (A, C, W, and Y) in Group 1 versus Group 2 at day 30 after the second vaccine dose was demonstrated with seroprotection rates \u226599% against all capsular groups in both groups. In Group 3, cross-reactivity was observed, with hSBA titres against capsular groups A and C increasing &gt;10-fold after the third 4CMenB dose. Reactogenicity was consistent with the known profiles of both vaccines; one case of anaphylaxis related to MenACYW-TT was reported and resolved without sequelae. No new safety concerns were identified.<\/jats:p>","DOI":"10.1038\/s41541-026-01508-7","type":"journal-article","created":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T16:36:38Z","timestamp":1782923798000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Safety and immunogenicity of concomitant quadrivalent meningococcus ACYW-TT and meningococcus group B vaccines"],"prefix":"10.1038","volume":"11","author":[{"given":"Monica A.","family":"McArthur","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam","family":"Finn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lawrence","family":"Barnes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Burkimsher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katrina","family":"Cathie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eva","family":"Galiza","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Heaton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Jacobsen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sian","family":"Ludman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Patrick","family":"Moore","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Clare","family":"Murray","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel","family":"Owens","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alexander","family":"Trotman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ray","family":"Borrow","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Chaix","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Arlette","family":"Delgado","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Estelle","family":"Dubois","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Youjun","family":"Huang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Olga","family":"Syrkina","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Betzana","family":"Zambrano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mandeep Singh","family":"Dhingra","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":[[2026,7,1]]},"reference":[{"key":"1508_CR1","doi-asserted-by":"publisher","first-page":"1147","DOI":"10.1007\/s40265-013-0079-2","volume":"73","author":"AC Cohn","year":"2013","unstructured":"Cohn, A. 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E.D. is an employee of Aixial, working on behalf of Sanofi. A.F. has led studies and vaccine trials funded by the following meningococcal vaccine manufacturers: Sanofi, Pfizer, GSK and MSD. A.F. currently or recently has undertaken paid consultancy for Sanofi, GSK and several other vaccine companies who do not make and are not developing meningococcal vaccines, and was formerly a member of the UK NITAG, the JCVI and chair of the WHO Euro TAG on Immunisation (ETAGE) and continues to advise the UK government and WHO on sub-committees and working groups. RBw performs contract research on behalf of UKHSA for GSK, PATH, Pfizer and Sanofi. K.C. acts on behalf of University Hospital Southampton NHS Foundation Trust as an investigator and\/or providing consultative advice on studies funded or sponsored by vaccine manufacturers including AstraZeneca, GlaxoSmithKline, Janssen, Medimmune, Merck, Pfizer, Sanofi, Iliad, Moderna and Valneva. She receives no personal financial payment for this work. E.G. reports receiving research funding for clinical trials from GSK, Moderna, Janssen, and MSD; all payments were made to her institution. D.O. reports receiving research funding for clinical trials from Pfizer, Sanofi, GSK, AstraZeneca, ILiAD, Moderna, and Novartis; all payments were made to his institution. The other authors (L.B., R.B., P.H., N.J., S.J., S.L., P.M., C.M. and A.T.) declare no competing interests.","order":1,"name":"Ethics","label":"Competing interests","group":{"name":"EthicsHeading","label":"Ethics"}}],"article-number":"195"}}