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New RNA flu vaccine could be a Game-Changer – early trial underway

NCT ID NCT05227001

Vaccine Sponsor: Pfizer 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Pfizer is testing a new type of flu vaccine called a self-amplifying RNA (saRNA) vaccine. This early study involves 440 healthy adults aged 18 to 49. Participants receive either the saRNA vaccine, a licensed flu shot, or a placebo. The main goal is to check safety and side effects, with a secondary look at immune response. The trial is already completed.

What this could mean

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

Active substance
self-amplifying RNA (saRNA) flu vaccine
What this could lead to
If successful, this could lead to a more effective flu vaccine that requires lower doses and provides stronger protection.
What could go wrong
This is an early Phase 1 trial focused on safety, not yet proving the vaccine works. The saRNA technology is new, and side effects or limited immune response are possible.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

440 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 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 to 49 years

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: * Male or female participants 18 to 49 years of age. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. * Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not of childbearing potential; or male participant not able to father children. * Capable of giving signed informed consent. Exclusion Criteria: * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention. * Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. * Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection. * Women who are pregnant or breastfeeding. * Allergy to egg proteins (egg or egg products) or chicken proteins. * Participant who has had significant exposure to laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 infection), coronavirus disease 2019 (COVID-19), or influenza in the past 14 days known prior to Visit 1 * Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 1 that has not been confirmed as negative. * Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. * Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study. * Vaccination with any influenza vaccine within 6 months (175 days) before study intervention administration. * Any participant who has received or plans to receive a nucleoside-modified messenger ribonucleic acid (modRNA)-platform SARS-CoV-2 vaccine within 60 days of Visit 1 * Previous vaccination with an saRNA or an alphavirus replicon vaccine preparation. * Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation. * Screening hematology/blood chemistry lab \>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator. * Screening electrocardiogram (ECG) that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or study results. * Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members. * Participation in strenuous or endurance exercise through Visit 3. * Prior history of heart disease.

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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

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147, United States

  • Arizona Heart Rhythm Center

    Phoenix, Arizona, 85016, United States

  • Benchmark Research

    Austin, Texas, 78705, United States

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212, United States

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405, United States

  • Comprehensive Cardiology Consultants

    Pembroke Pines, Florida, 33028, United States

  • DM Clinical Research, Martin Diagnostic Clinic

    Tomball, Texas, 77375, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • Eric S. Tiblier, MD

    Austin, Texas, 78705, United States

  • Finlay Medical Research

    Greenacres City, Florida, 33467, United States

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois, 60640, United States

  • Hope Research Institute

    Phoenix, Arizona, 85018, United States

  • Miami Clinical Research

    Miami, Florida, 33155, United States

  • Mount Sinai Hospital

    Miami Beach, Florida, 33140, United States

  • NYU Langone Health

    New York, New York, 10016, United States

  • Panax Clinical Research

    Miami Lakes, Florida, 33014, United States

  • Pines Care Research Center, LLC

    Pembroke Pines, Florida, 33024, United States

  • Pinnacle Health Care Center

    Pembroke Pines, Florida, 33024, United States

  • Pioneer Heart Institute

    Lincoln, Nebraska, 68506, United States

  • SUNY Upstate Medical University

    Syracuse, New York, 13215, United States

  • SUNY Upstate Medical University Global Health Laboratory

    Syracuse, New York, 13210, United States

  • SUNY Upstate Medical University Institute for Global Health

    Syracuse, New York, 13215, United States

  • The Pain Center of Arizona

    Phoenix, Arizona, 85018, United States

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.