{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Jain V"],"funding":["GlaxoSmithKline"],"pagination":["2578084"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC12574568"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["21(1)"],"pubmed_abstract":["<i>Fluarix Tetra</i> is a quadrivalent seasonal influenza vaccine that has been approved in India for immunization of adults and children aged ≥6 months. This study was conducted in adults aged ≥65 years in India to fulfill a post-approval regulatory commitment. In this prospective, multicenter, single-arm, open-label, Phase 4 study, participants were administered a single 0.5-mL dose of <i>Fluarix Tetra</i> (2023-2024 Northern Hemisphere). The primary objectives were to assess the reactogenicity and safety of <i>Fluarix Tetra</i> by monitoring solicited adverse events (AEs) within 7 days post-vaccination, as well as unsolicited AEs and serious AEs (SAEs) within 21 days post-vaccination. The secondary objective was to evaluate immunogenicity by monitoring the geometric mean titers, geometr"],"journal":["Human vaccines & immunotherapeutics"],"pubmed_title":["Reactogenicity, safety, and immunogenicity of a quadrivalent seasonal influenza vaccine in adults aged 65 years and older: Phase 4 study results from India during December 2023-February 2024."],"pmcid":["PMC12574568"],"funding_grant_id":["218702"],"pubmed_authors":["Qian H","Struyf F","Gupta V","Tatchou EN","Cauwberghs F","Jain V","Best-Sule K"],"additional_accession":[]},"is_claimable":false,"name":"Reactogenicity, safety, and immunogenicity of a quadrivalent seasonal influenza vaccine in adults aged 65 years and older: Phase 4 study results from India during December 2023-February 2024.","description":"<i>Fluarix Tetra</i> is a quadrivalent seasonal influenza vaccine that has been approved in India for immunization of adults and children aged ≥6 months. This study was conducted in adults aged ≥65 years in India to fulfill a post-approval regulatory commitment. In this prospective, multicenter, single-arm, open-label, Phase 4 study, participants were administered a single 0.5-mL dose of <i>Fluarix Tetra</i> (2023-2024 Northern Hemisphere). The primary objectives were to assess the reactogenicity and safety of <i>Fluarix Tetra</i> by monitoring solicited adverse events (AEs) within 7 days post-vaccination, as well as unsolicited AEs and serious AEs (SAEs) within 21 days post-vaccination. The secondary objective was to evaluate immunogenicity by monitoring the geometric mean titers, geometr","dates":{"release":"2025-01-01T00:00:00Z","publication":"2025 Dec","modification":"2026-07-15T06:11:41.18Z","creation":"2026-06-30T03:16:35.158Z"},"accession":"S-EPMC12574568","cross_references":{"pubmed":["41159757"],"doi":["10.1080/21645515.2025.2578084"]}}