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New adjuvanted flu vaccine aims to boost protection in older adults

NCT ID NCT05501561

Vaccine Sponsor: Seqirus Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This phase 2b trial tests several versions of an experimental flu vaccine that includes an adjuvant (MF59) to strengthen the immune response. The vaccine is made from cells, not eggs, and targets four flu strains. Around 1,000 adults aged 50 and older receive a single shot and are followed for about six months to check safety and immune response. The goal is to find the best dose of antigen and adjuvant for this age group.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MF59-adjuvanted quadrivalent cell-derived influenza vaccine
What this could lead to
If successful, this vaccine could offer stronger and broader protection against seasonal flu for older adults, who are at higher risk of severe illness.
What could go wrong
This is a mid-stage trial focused on immune response, not yet proven to prevent flu in the real world. Different formulations are being compared, and the best one may still fail in later studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

1,056 people

The number who actually took part.

Started

Aug 2022

Finished

Mar 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: In order to participate in this study, all subjects must meet ALL of the inclusion criteria described. 1. Individuals ≥50 years of age on the day of informed consent. 2. Individuals who have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. Individuals who can comply with study procedures including follow-up . 4. Males, females of non-childbearing potential or females of childbearing potential who are using an effective birth control method, at least 30 days prior to informed consent, which they intend to use for at least 2 months after the study vaccination. \- Exclusion Criteria: In order to participate in this study, all subjects must not meet ANY of the exclusion criteria described below: 1. Females of childbearing potential who are pregnant, lactating, or who have not adhered to a specified set of contraceptive methods from at least 30 days prior to informed consent and who do not plan to do so for at least 2 months after the study vaccination. 2. Progressive, unstable or uncontrolled clinical conditions. 3. Hypersensitivity, including allergy, to any component of vaccines whose use is foreseen in this study. 4. History of any medical condition considered an adverse event of special interest (AESI). 5. Known history of Guillain-Barré syndrome or another demyelinating disease such as encephalomyelitis and transverse myelitis. 6. Clinical conditions representing a contraindication to intramuscular administration of vaccines or blood draw. 7. Abnormal function of the immune system resulting from: 1. Clinical conditions. 2. Systemic administration of corticosteroids (PO/IV/IM) at a dose of ≥20 mg/day of prednisone or equivalent for more than 14 consecutive days within 90 days prior to informed consent5. 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. 8. Receipt of immunoglobulins or any blood products within 180 days prior to informed consent. 9. Receipt of an investigational or non-registered medicinal product within 30 days prior to informed consent. 10. Receipt of any COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to informed consent or plan to receive any COVID-19 vaccine within 7 days from study vaccination 11. Individuals who received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to informed consent or who are planning to receive any vaccine within 28 days from the study vaccines. 12. Study personnel or immediate family or household member of study personnel. 13. Receipt of any influenza vaccine within 6 months prior to informed consent, or plan to receive an influenza vaccine during the study period. 14. Acute (severe) febrile illness, 15. 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. \-

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Conditions

The condition(s) this trial relates to.

influenza prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Influenza, human

Contacts and locations

Locations

  • AMR Coastal Clinical Research

    Knoxville, Tennessee, 37920, United States

  • AMR El Dorado

    El Dorado, Kansas, 67042, United States

  • AMR Lexington

    Lexington, Kentucky, 40509, United States

  • AMR Tempe

    Tempe, Arizona, 85281, United States

  • Alliance for Multispecialty Research, LLC, Las Vegas

    Las Vegas, Nevada, 89119, United States

  • Aventiv Research, Inc. Columbus

    Columbus, Ohio, 43213, United States

  • CVS pharmacy - Charlottesville

    Charlottesville, Virginia, 22902, United States

  • CVS pharmacy - Reston

    Reston, Virginia, 20190, United States

  • CVS pharmacy - Richmond

    Richmond, Virginia, 23235, United States

  • California Research Center

    San Diego, California, 92123, United States

  • CenExel RCA

    Hollywood, Florida, 33024, United States

  • Clinical Research Consulting, LLC

    Milford, Connecticut, 06460, United States

  • DM Clinical Research

    Tomball, Texas, 77375, United States

  • Global Health Research Center

    Miami Lakes, Florida, 33016, United States

  • Global Health Research Center

    Tampa, Florida, 33615, United States

  • Health Awareness INC

    Jupiter, Florida, 33458, United States

  • Healthcare Research Network

    Hazelwood, Missouri, 63042, United States

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756, United States

  • JBR Clinical Research

    Salt Lake City, Utah, 84107, United States

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112, United States

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612, United States

  • Marvel Clinical Research

    Huntington Beach, California, 92647, United States

  • MedPharmics LLC

    Biloxi, Mississippi, 39531, United States

  • Medpharmics, LLC

    Metairie, Louisiana, 70006, United States

  • Meridian Clinical Research

    Baton Rouge, Louisiana, 70808, United States

  • Meridian Clinical Research

    Bellevue, Nebraska, 68005, United States

  • Meridian Clinical Research

    Grand Island, Nebraska, 68803, United States

  • Meridian Clinical Research (Binghamton, NY)

    Binghamton, New York, 13901, United States

  • Meridian Clinical Research - Dakota Dunes

    Dakota Dunes, South Dakota, 57049, United States

  • Meridian Clinical Research - Savannah

    Savannah, Georgia, 31406, United States

  • Meridian Clinical Research, LLC

    Lincoln, Nebraska, 68510, United States

  • Meridian Clinical Research, LLC

    Endwell, New York, 13760, United States

  • Meridian Clinical Research, LLC

    Cincinnati, Ohio, 45219, United States

  • Meridian Clinical Research, LLC

    Cincinnati, Ohio, 45246, United States

  • Platinum Research Network, LLC

    Savannah, Georgia, 31405, United States

  • Precision Clinical Research

    Sunrise, Florida, 33351, United States

  • Rockville Internal Medicine Group

    Rockville, Maryland, 20854, United States

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141, United States

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114, United States

  • The Lynn Institute of The Rockies

    Colorado Springs, Colorado, 80920, United States

  • Velocity Clinical Research - Greenville

    Greenville, South Carolina, 29615, United States

  • Velocity Clinical Research - Medford

    Medford, Oregon, 97504, United States

  • Velocity Clinical Research - New Smyrna Beach

    Edgewater, Florida, 32132, United States

  • Velocity Clinical Research - Syracuse

    Syracuse, New York, 13057, United States

  • Velocity Clinical Research - West Jordan

    West Jordan, Utah, 84088, United States

  • Velocity Clinical Research, Gaffney

    Gaffney, South Carolina, 29340, United States

  • Velocity Clinical Research, Spartanburg

    Spartanburg, South Carolina, 29303, United States

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