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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 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- BIOLOGICAL aQIV or aTIV
- BIOLOGICAL QIV or TIV
Study Locations (20)
California
- 84101-West Coast Research LLC — Dublin
- 84124-Leading Edge Research — Encino
- 84104-Zillan Clinical Research — Inglewood
- 84105-Eximia Research - CA — La Mesa
- 84107-Long Beach Research Institute — Long Beach
- 84109-Long Beach Clinical Trials — Long Beach
- 84115-Central Valley Research — Modesto
- 84120-Paradigm Research — Redding
- 84119-Apex Clinical Research — San Diego
Colorado
- 84125-Lynn Institute of Denver — Aurora
- 84110-Tekton Research — Longmont
- 84123-Paradigm Research — Wheat Ridge
Alabama
- 84046-Accel Research Sites - Birmingham — Birmingham
- 84075-Cullman Clinical Trials — Cullman
Arizona
- 84112-DM Clinical Research - Phoenix — Phoenix
- 84114-Scottsdale Clinical Trials — Scottsdale
Arkansas
- 84045-Lynn Institute of the Ozarks — Little Rock
- 84070-Baptist Health Center for Clinical Research — Little Rock
Connecticut
- 84085-Clinical Research Consulting, LLC — Milford
- 84017-Chase Medical Research, LLC — Waterbury
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35,800 participants |
| Start Date | 2023-10-23 |
| Est. Completion | 2026-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06087640
The ClinicalTrials.gov registry entry for NCT06087640 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 35,800 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Seqirus, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Influenza, Human appearing as the primary indexed condition, and to 2 interventions — of which aQIV or aTIV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06087640 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Colorado, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06087640 about?
NCT06087640 is a clinical study titled "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". 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 in...
What is the current status of trial NCT06087640?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 35,800 participants. The study started on 2023-10-23. Estimated completion is 2026-12.
What conditions does trial NCT06087640 study?
This clinical trial studies the following conditions: Influenza, Human. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06087640?
The interventions under investigation include: aQIV or aTIV (BIOLOGICAL), QIV or TIV (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06087640?
This trial is sponsored by Seqirus, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06087640 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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