clinical trial · NCT05648357
A Study to Assess the Safety and Immune Response of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India
GlaxoSmithKline·phase4·completed·n = 250
Influenza, HumanFluarix Tetra Vaccine
brief summary
The purpose of this study is to gather additional evidence of the safety and immunogenicity of 1 dose of Fluarix Tetra (0.5 milliliter \[mL\]) (Northern Hemisphere (NH)2023-2024) in individuals aged 65 years and above to fulfill a post-approval condition imposed by the Indian regulatory authorities (CDSCO) for this age group in India.
started
Dec 14, 2023
primary completion
Feb 26, 2024
completion
Feb 26, 2024
last updated
Mar 28, 2025
official title
A Single-arm, Open-label, Multi-center, Phase IV Trial to Evaluate the Reactogenicity, Safety, and Immunogenicity of Quadrivalent Seasonal Influenza Vaccine (Fluarix Tetra) in Participants Aged 65 Years and Older in India
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol