{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["80(4)"],"submitter":["Nolan T"],"funding":["GSK"],"pubmed_abstract":["Background
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.Methods
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 o"],"journal":["Clinical infectious diseases : an official publication of the Infectious Diseases Society of America"],"pagination":["752-760"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12043065"],"repository":["biostudies-literature"],"pubmed_title":["Immunogenicity, 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."],"pmcid":["PMC12043065"],"pubmed_authors":["Gilsoul J","Richmond P","Gupta AK","Mzolo T","Llapur CJ","Domachowske J","Tiong F","Domachowske JB","Surber J","Ceballos A","Voloshyna O","Bloch MT","Gunner EA","Obed MN","Bhusal C","Bordon J","Lattanzi M","Bartlett A","Marc GP","Ampajwala M","Richmond PC","Wallace G","Kasarjian J","Yut C","Sullivan K","Soto AE","Rok W","Teijeiro RA","Gentile A","Farjo R","Toneatto D","BOOST Study Group","Byars W","Hoberman A","Hong M","Nolan T","Saravolatz L","Silas P","Fink E","Carr JPJ","OħMahony J","Arya M","de Looze F","Batra D","Wadia U","Akinsola A","Mann D","Riera FO","Deluca M","Mitchell G","Matherne PG"],"additional_accession":[]},"is_claimable":false,"name":"Immunogenicity, 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.","description":"Background
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.Methods
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 o","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Apr","modification":"2026-06-02T12:04:23.869Z","creation":"2025-07-08T03:13:47.733Z"},"accession":"S-EPMC12043065","cross_references":{"pubmed":["39722560"],"doi":["10.1093/cid/ciae622"]}}