{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["78(5)"],"submitter":["Usdan L"],"pubmed_abstract":["<h4>Background</h4>Protection against contemporary severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants requires sequence-adapted vaccines.<h4>Methods</h4>In this ongoing phase 2/3 trial, 12-17-year-olds (n = 108), 18-55-year-olds (n = 313), and >55-year-olds (n = 306) who previously received 3 original BNT162b2 30-µg doses, received a fourth dose (second booster) of 30-µg bivalent original/Omicron-BA.4/BA.5-adapted BNT162b2 (BNT162b2-Omi.BA.4/BA.5). For comparisons with original BNT162b2, participants were selected from another phase 3 trial. Immunologic superiority 1 month after vaccination, with respect to 50% neutralizing titers (lower bound [LB] of 2-sided 95% confidence interval [CI] for geometric mean ratio [GMR], >1), and noninferiority with respect to seroresponse"],"journal":["Clinical infectious diseases : an official publication of the Infectious Diseases Society of America"],"pagination":["1194-1203"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11093671"],"repository":["biostudies-literature"],"pubmed_title":["A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds."],"pmcid":["PMC11093671"],"pubmed_authors":["Sahin U","Stacey H","Rodriguez H","Christensen S","Andrews C","Tureci O","Davis M","Wyper H","Murray A","Martin E","Essink B","Fortmann S","Patel S","Miller D","Varano S","Chu L","Koury K","Anderson AS","Fragoso V","Usdan L","Lee DY","Mensa FJ","Lu C","Raad G","Finn D","Lowry FS","Chalhoub F","Cannon K","Heller R","Fitz-Patrick D","Senders S","Haggag A","Arora S","Lucasti C","Peterson J","Jennings T","Hartman A","Cooper D","Pickrell P","Wadsworth L","Kitchin N","Brandon D","Xu X","C4591044 Study Group","Swanson KA","Gruber WC"],"additional_accession":[]},"is_claimable":false,"name":"A Bivalent Omicron-BA.4/BA.5-Adapted BNT162b2 Booster in ≥12-Year-Olds.","description":"<h4>Background</h4>Protection against contemporary severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants requires sequence-adapted vaccines.<h4>Methods</h4>In this ongoing phase 2/3 trial, 12-17-year-olds (n = 108), 18-55-year-olds (n = 313), and >55-year-olds (n = 306) who previously received 3 original BNT162b2 30-µg doses, received a fourth dose (second booster) of 30-µg bivalent original/Omicron-BA.4/BA.5-adapted BNT162b2 (BNT162b2-Omi.BA.4/BA.5). For comparisons with original BNT162b2, participants were selected from another phase 3 trial. Immunologic superiority 1 month after vaccination, with respect to 50% neutralizing titers (lower bound [LB] of 2-sided 95% confidence interval [CI] for geometric mean ratio [GMR], >1), and noninferiority with respect to seroresponse","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 May","modification":"2026-06-02T21:23:23.757Z","creation":"2026-04-20T03:14:19.925Z"},"accession":"S-EPMC11093671","cross_references":{"pubmed":["38016021"],"doi":["10.1093/cid/ciad718"]}}