drugset / Trial / NCT06087640
A Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an Adjuvanted Influenza Vaccine Compared to a Non-adjuvanted Influenza Vaccine in Adults ≥65 Years of Age
RandomizedParallel-groupQuadruple-blindPrevention
Summary
This Phase 3 study is a randomized, observer-blind study of MF59-adjuvanted influenza vaccine (aQIV or aTIV) compared with a non-adjuvanted influenza vaccine (QIV or TIV) in adults ≥65 years of age. The aim of the study is to evaluate MF59-adjuvanted influenza vaccine compared with non-adjuvanted influenza vaccine in the prevention of reverse transcription-polymerase chain reaction (RT-PCR)-confirmed influenza A and/or B in subjects ≥65 years of age.
Timeline
- Start
- 2023-10-23
- Primary completion
- 2026-05-26
- Completion
- 2026-06-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | QIV | Vaccine | 0.5 ml | Intramuscular |
| Subject | TIV | Vaccine | 0.5 ml | Intramuscular |
| Subject | aQIV | Vaccine | 0.5 ml | Intramuscular |
| Subject | aTIV | Vaccine | 0.5 ml | Intramuscular |