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

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.

Timeline

Start

2023-12-14

Primary completion

2024-02-26

Completion

2024-02-26

Publications

• Jain V, Cauwberghs F, Qian H, Best-Sule K, Gupta V, Tatchou EN, Struyf F. 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. Hum Vaccin Immunother. 2025 Dec;21(1):2578084. doi: 10.1080/21645515.2025.2578084. Epub 2025 Oct 29.

Drugs

Indications