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.

ABSTRACT: Fluarix Tetra 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 Fluarix Tetra (2023-2024 Northern Hemisphere). The primary objectives were to assess the reactogenicity and safety of Fluarix Tetra 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

SUBMITTER: Jain V 

PROVIDER: S-EPMC12574568 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature