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New bird flu booster shot shows promise in early trial

NCT ID NCT05422326

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a booster vaccine for H5N6 bird flu in about 260 adults. Some had previously received an H5N1 bird flu vaccine, while others had not. The goal was to see if the booster was safe and triggered a strong immune response. Participants received one or two doses of the H5N6 vaccine and were monitored for about 7 months.

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 H5N6 bird flu vaccine
What this could lead to
If successful, this could help create a strategy to quickly boost immunity against new bird flu strains, potentially preventing a future pandemic.
What could go wrong
This is a Phase 2 study with only 260 participants, so results may not apply to everyone. The vaccine targets a specific bird flu strain, and its effectiveness against other strains is unknown.

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

260 people

The number who actually took part.

Started

Jul 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

18 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: * Subjects who received 2 doses of aH5N1c vaccine or placebo in and completed the parent study V89\_18 in the \<65 years of age cohort. * Individuals who can comply with study procedures including follow-up. Exclusion Criteria: * 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 study entry and who do not plan to do so until at least 30 days after the last study vaccination. * Progressive, unstable or uncontrolled clinical conditions. * Hypersensitivity, including allergy, to any component of vaccines, medicinal products or medical equipment whose use is foreseen in this study. * Clinical conditions representing a contraindication to intramuscular vaccination and blood draws. * Abnormal function of the immune system. * History of any medical condition considered an adverse event of special interest (AESI). * Received immunoglobulins with immunomodulating effects or any blood products within 180 days prior to informed consent. * Subjects, who received an influenza H5 vaccine other than in the V89\_18 parent study or have a history of H5 influenza infection prior to enrollment. * Received an investigational or non-registered medicinal product within 30 days prior to informed consent. * Individuals who received any other vaccines \[except corona virus disease 2019 (COVID-19) vaccines\] within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccination. * Receipt of any COVID-19 vaccine within 7 days prior to enrollment or plan to receive any COVID-19 vaccine within 7 days from study vaccination. * Acute (severe) febrile illness. * A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis.

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Conditions

The condition(s) this trial relates to.

avian influenza Infections infectious disease respiratory system disorder respiratory tract infectious disorder RNA Virus Infections viral infectious disease influenza prevention target

As listed by the trial registrant

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

Infections Influenza in birds Influenza, human Orthomyxoviridae infections Respiratory tract diseases Respiratory tract infections Rna virus infections Virus diseases

Contacts and locations

Locations

  • AccellaCare

    Winston-Salem, North Carolina, 27103, United States

  • Aventiv Research

    Columbus, Ohio, 43213, United States

  • Biogenics Research Institute

    San Antonio, Texas, 78229, United States

  • California Research Foundation

    San Diego, California, 92103, United States

  • Clinical Research Consortium Arizona

    Tempe, Arizona, 85283, United States

  • Clinical Research Consulting, LLC

    Milford, Connecticut, 06460, United States

  • Great Lakes Clinical Trials LLC

    Chicago, Illinois, 60640, United States

  • Heartland Research Associates, LLC

    Wichita, Kansas, 67207, United States

  • Innovative Research of West Florida, Inc.

    Clearwater, Florida, 33756, United States

  • J. Lewis Research, Inc/Foothill Family Clinic North

    Salt Lake City, Utah, 84109, United States

  • J. Lewis Research, Inc/Foothill Family Clinic South

    Salt Lake City, Utah, 84121, United States

  • J. Lewis Research, Inc/Jordan River Family Medicine

    South Jordan, Utah, 84095, United States

  • Optimal Research, LLC

    Huntsville, Alabama, 35802, United States

  • Optimal Research, LLC

    Melbourne, Florida, 32934, United States

  • PMG Research of Raleigh

    Raleigh, North Carolina, 27609, United States

  • Rochester Clinical Research, Inc

    Rochester, New York, 14609, United States

  • Sundance Clinical Research, LLC

    St Louis, Missouri, 63141, United States

  • The Center for Pharmaceutical Research

    Kansas City, Missouri, 64114, United States

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