Safety and Immunogenicity of an MF59-Adjuvanted Influenza Vaccine in Older Adults

Summary

This Phase 2, randomized, observer-blind, active controlled clinical study is evaluating the safety and immunogenicity of the investigational MF59-Adjuvanted Quadrivalent Subunit Inactivated Influenza Vaccine. Approximately 480 subjects are to be randomized into 1 of 4 possible treatment groups (investigational Influenza Vaccine or licensed Quadrivalent Influenza Vaccine comparators) at 120 participants per group. Every participant will receive an influenza vaccine injection on Day 1 and will be followed up for approximately 6 months following injection. The primary immunogenicity analysis is based on Day 29 serum.

Timeline

Start

2020-10-08

Primary completion

2021-03-19

Completion

2021-05-24

Publications

• Essink BJ, Vermeulen W, Andrade C, de Rooij R, Isakov L, Casula D, Albano FR. A randomised phase 2 immunogenicity and safety study of a MF59-adjuvanted quadrivalent subunit inactivated cell-derived influenza vaccine (aQIVc) in adults aged 50 years and older. Vaccine. 2025 Apr 2;51:126791. doi: 10.1016/j.vaccine.2025.126791. Epub 2025 Feb 12.

Drugs

Indications