Can a tweaked bird flu shot build stronger immunity?
NCT ID NCT05875961
First seen Sep 21, 2026 · Last updated Sep 21, 2026
Summary
Researchers are testing six different formulations of a cell culture-derived H2N3 influenza vaccine in about 600 healthy adults aged 18 and older. Participants receive two injections three weeks apart and are followed for about a year. The study measures antibody levels and checks for side effects to see which dose and whether adding the MF59 adjuvant produces the best immune response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental cell culture-derived H2N3 influenza vaccine, given with or without the MF59 adjuvant
- What this could lead to
- If it works, this could add a new vaccine option against the H2N3 bird flu strain, which has pandemic potential. It could also show whether the MF59 adjuvant lets smaller doses work as well as larger ones.
- What could go wrong
- This is a Phase 1 study, so its main job is to check safety and immune response, not to prove the vaccine prevents flu. Many early vaccine candidates do not move forward, and side effects like soreness, fever, or fatigue are common with flu shots.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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600 people
The number who actually took part.
- Started
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Jun 2023
- Finished
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Nov 2024
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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: * Individuals of 18 years of age and older on the day of informed consent who were not born in 1968. * 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 can comply with study procedures including follow-up. * 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 last study vaccination. 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 2 months after the last study vaccination. * A body mass index (BMI) ≥35 kg/m2. * Progressive, unstable, or uncontrolled clinical conditions as per investigator's assessment. Subjects must be stable and unchanged for a minimum of 3 months. * 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 resulting from: 1. Clinical conditions. 2. Systemic administration of corticosteroids at a dose of ≥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. 3. Administration of antineoplastic and immunomodulating agents or radiotherapy within 90 days prior to informed consent. * 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. * Received an investigational or non-registered medicinal product within 30 days prior to informed consent. * Study personnel or immediate family or household member of study personnel. * 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. * Individuals who received any other vaccines (with the exception of COVID-19 vaccines) within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 28 days from the study vaccines. * Receipt of any (investigational or licensed) COVID-19 vaccine within 14 days (non-replicating vaccines) or 28 days (replicating vaccines) prior to enrollment or plan to receive any COVID-19 vaccine within 14 days from study vaccination. * 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Manila Doctors Hospital
Manila, Philippines
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Meridian Clinical Research
Rockville, Maryland, 20854, United States
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Meridian Clinical Research
Lincoln, Nebraska, 68510, United States
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Meridian Clinical Research
Omaha, Nebraska, 58134, United States
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Quirino Memorial Medical Center
Quezon City, Philippines
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Silang Specialists Medical Center
Silang, Philippines
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West Visayas State University Medical Center
Iloilo City, Philippines
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