biostudies-literatureUnknown80(4)Nolan TGSK<h4>Background</h4>A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the 5 meningococcal serogroups that cause most invasive disease cases.<h4>Methods</h4>In this phase 3 study, healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive 2 MenABCWY doses 6 months apart or 1 MenACWY-CRM dose. Primary objectives were to demonstrate the noninferiority of MenABCWY 1 month postvaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety. Secondary endpoints included percentages oClinical infectious diseases : an official publication of the Infectious Diseases Society of America752-760https://www.ebi.ac.uk/biostudies/studies/S-EPMC12043065biostudies-literatureImmunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults Who Had Previously Received a Meningococcal ACWY Vaccine: A Phase 3, Randomized Controlled Clinical Study.PMC12043065Gilsoul JRichmond PGupta AKMzolo TLlapur CJDomachowske JTiong FDomachowske JBSurber JCeballos AVoloshyna OBloch MTGunner EAObed MNBhusal CBordon JLattanzi MBartlett AMarc GPAmpajwala MRichmond PCWallace GKasarjian JYut CSullivan KSoto AERok WTeijeiro RAGentile AFarjo RToneatto DBOOST Study GroupByars WHoberman AHong MNolan TSaravolatz LSilas PFink ECarr JPJOħMahony JArya Mde Looze FBatra DWadia UAkinsola AMann DRiera FODeluca MMitchell GMatherne PGfalseImmunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults Who Had Previously Received a Meningococcal ACWY Vaccine: A Phase 3, Randomized Controlled Clinical Study.<h4>Background</h4>A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the 5 meningococcal serogroups that cause most invasive disease cases.<h4>Methods</h4>In this phase 3 study, healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive 2 MenABCWY doses 6 months apart or 1 MenACWY-CRM dose. Primary objectives were to demonstrate the noninferiority of MenABCWY 1 month postvaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety. Secondary endpoints included percentages o2025-01-01T00:00:00Z2025 Apr2026-06-02T12:04:23.869Z2025-07-08T03:13:47.733ZS-EPMC120430653972256010.1093/cid/ciae622