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

Completed · Phase 3

Conditions studied: Influenza, Human

In brief

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.

Key facts

Study ID

NCT06087640

Run by

Seqirus

People needed

38769

Starts

2023-10-23

Expected to finish

2026-06-15

Last updated by the study team

2026-06-23

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
• Adults of ≥65 years of age on the day of vaccination.
• Individuals who have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
• Individuals who have the ability to comply with study procedures including follow-up.

You may not qualify if…

• In order to participate in this study, all subjects must not meet any of the exclusion criteria described below:
• Bedridden subjects (i.e. confined to bed by sickness or old age).
• Subjects that are incapacitated and because of that in need of a Legally Authorized Representative.
• Receipt of any influenza vaccine within 6 months prior to enrollment or any plan to receive influenza vaccine while participating in the study.
• Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study, or severe allergic reaction (e.g. anaphylaxis) to previous influenza vaccination.
• Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis.
• Clinical conditions representing a contra-indication to intramuscular administration of vaccines or blood draw.
• Abnormal function of the immune system resulting from:
• Clinical conditions;
• Systemic administration of corticosteroids (PO/IV/IM) at a dose ≥20 mg/day of prednisone (or equivalent) for more than 14 consecutive days within 90 days prior to informed consent; Topical, inhaled and intranasal corticosteroids are permitted. Intermittent use (one dose in 30 days) of intra-articular corticosteroids are also permitted;
• Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent.
• Receipt of immunoglobulins or any blood products within 180 days prior to informed consent.
• Receipt of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the study vaccination, or planned use during the entire study period.
• Acute (severe) febrile illness.
• Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study.
• Study personnel or immediate family members (brother, sister, child, parent) or the spouse of study personnel.

Where it is running

• 84046-Accel Research Sites - Birmingham — Birmingham, Alabama, United States
• 84075-Cullman Clinical Trials — Cullman, Alabama, United States
• 84112-DM Clinical Research - Phoenix — Phoenix, Arizona, United States
• 84114-Scottsdale Clinical Trials — Scottsdale, Arizona, United States
• 84045-Lynn Institute of the Ozarks — Little Rock, Arkansas, United States
• 84070-Baptist Health Center for Clinical Research — Little Rock, Arkansas, United States
• 84101-West Coast Research LLC — Dublin, California, United States
• 84124-Leading Edge Research — Encino, California, United States
• 84104-Zillan Clinical Research — Inglewood, California, United States
• 84105-Eximia Research - CA — La Mesa, California, United States
• 84107-Long Beach Research Institute — Long Beach, California, United States
• 84109-Long Beach Clinical Trials — Long Beach, California, United States
• 84115-Central Valley Research — Modesto, California, United States
• 84120-Paradigm Research — Redding, California, United States
• 84119-Apex Clinical Research — San Diego, California, United States
• 84125-Lynn Institute of Denver — Aurora, Colorado, United States
• 84110-Tekton Research — Longmont, Colorado, United States
• 84123-Paradigm Research — Wheat Ridge, Colorado, United States
• 84085-Clinical Research Consulting, LLC — Milford, Connecticut, United States
• 84017-Chase Medical Research, LLC — Waterbury, Connecticut, United States
• 84029-Imagine Research of Palm Beach County — Boynton Beach, Florida, United States
• 84067-Innovative Research of West Florida, Inc. — Clearwater, Florida, United States
• 84006-Nature Coast Clinical Research - Crystal River — Crystal River, Florida, United States
• 84012-Evolution Clinical Trials — Doral, Florida, United States
• 71010-Merclinico Middelburg — Middelburg, South Africa

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.