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

NCT06087640 ↗

Phase 3 Completed 38769 enrolled Seqirus
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

EvaluationDrugModalityDoseRoute
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

Indications