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Influenza, HumanPhase 1NCT05227001

A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza

A Phase 1 study testing PF-07852352 Influenza saRNA 1, PF-07836391 Influenza saRNA and PF-07836394 Influenza saRNA in people with Influenza, Human, run by Pfizer at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who: Are between the age of 18 to 49 years old. Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
PF-07852352 Influenza saRNA 1, PF-07836391 Influenza saRNA and PF-07836394 Influenza saRNA
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
440 participants
Where
24 sitesUnited States
Study dates
28 Apr 2022to 4 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 19Show fewer
  • 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.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Benchmark Research

    Austin, Texas, 78705

  • Eric S. Tiblier, MD

    Austin, Texas, 78705

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois, 60640

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Finlay Medical Research

    Greenacres City, Florida, 33467

  • Pioneer Heart Institute

    Lincoln, Nebraska, 68506

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • Miami Clinical Research

    Miami, Florida, 33155

  • Mount Sinai Hospital

    Miami Beach, Florida, 33140

  • Panax Clinical Research

    Miami Lakes, Florida, 33014

  • NYU Langone Health

    New York, New York, 10016

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134

  • Pines Care Research Center, LLC

    Pembroke Pines, Florida, 33024

  • Pinnacle Health Care Center

    Pembroke Pines, Florida, 33024

  • Comprehensive Cardiology Consultants

    Pembroke Pines, Florida, 33028

  • Arizona Heart Rhythm Center

    Phoenix, Arizona, 85016

  • Hope Research Institute

    Phoenix, Arizona, 85018

  • The Pain Center of Arizona

    Phoenix, Arizona, 85018

  • SUNY Upstate Medical University Global Health Laboratory

    Syracuse, New York, 13210

  • SUNY Upstate Medical University Institute for Global Health

    Syracuse, New York, 13215

  • SUNY Upstate Medical University

    Syracuse, New York, 13215

  • DM Clinical Research, Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

Other trials in United States

About this study

Official title: A PHASE 1, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND, DOSE-FINDING STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF SELF-AMPLIFYING RNA VACCINE PREPARATIONS AGAINST INFLUENZA IN HEALTHY INDIVIDUALS

The purpose of this clinical trial is to learn about the safety and effects of the study vaccine for the potential prevention of influenza. The study vaccine is called Self-Amplifying Ribonucleic Acid vaccine (saRNA vaccine). This study is seeking participants who:

  • Are between the age of 18 to 49 years old.
  • Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Are healthy as determined by medical history, physical examinations, and the study doctor.
  • For male participants, can father children and willing to use an acceptable method of contraception. Female participants who are not of childbearing potential; or male participant not able to father children.
  • Are capable of giving signed informed consent. Participants will receive either the saRNA vaccine, a licensed Influenza Vaccine (QIV) or a placebo. Participants will not know which vaccine they receive in advance. A placebo does not have any medicine in it but looks just like the study medicine. Participants will receive the study vaccines as a single shot in the arm. We will compare participant experiences to help us determine if the saRNA vaccine is safe and effective. Participants will take part in this study for 6 months. During this time, they will receive the study vaccine and participate in follow-up visits.
Being tested
PF-07852352 Influenza saRNA 1, PF-07836391 Influenza saRNA, PF-07836394 Influenza saRNA, PF-07836395 Influenza saRNA, PF-07836396 Influenza saRNA
Keywords
Grippe, Flu, Influenza, Vaccine, RNA vaccine, Self-amplifying
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-07852352 Influenza saRNA 1Biological

    Intramuscular injection

  • PF-07836391 Influenza saRNABiological

    Intramuscular injection

  • PF-07836394 Influenza saRNABiological

    Intramuscular injection

  • PF-07836395 Influenza saRNABiological

    Intramuscular injection

  • PF-07836396 Influenza saRNABiological

    Intramuscular injection

  • PF-07867246 Influenza saRNABiological

    Intramuscular injection

  • PlaceboBiological

    Intramuscular injection

  • Quadrivalent influenza vaccine (QIV)Biological

    Intramuscular injection

  • PF-07871987 Influenza saRNABiological

    Intramuscular injection

  • PF-07914705 Influenza saRNABiological

    Intramuscular injection

  • PF-07915048 Influenza saRNABiological

    Intramuscular injection

Study groups in NCT05227001
Study groupRoleWhat they receive
PF-07852352 Influenza saRNA, low doseExperimentalNot described
Receives: Biological: PF-07852352 Influenza saRNA 1
PF-07852352 Influenza saRNA, mid doseExperimentalNot described
Receives: Biological: PF-07852352 Influenza saRNA 1
PF-07852352 Influenza saRNA, high doseExperimentalNot described
Receives: Biological: PF-07852352 Influenza saRNA 1
PF-07836391 Influenza saRNA, low doseExperimentalNot described
Receives: Biological: PF-07836391 Influenza saRNA
PF-07836391 Influenza saRNA, mid doseExperimentalNot described
Receives: Biological: PF-07836391 Influenza saRNA
PF-07836391 Influenza saRNA, high doseExperimentalNot described
Receives: Biological: PF-07836391 Influenza saRNA
PF-07836394 Influenza saRNA, low doseExperimentalNot described
Receives: Biological: PF-07836394 Influenza saRNA
PF-07836394 Influenza saRNA, mid doseExperimentalNot described
Receives: Biological: PF-07836394 Influenza saRNA
PF-07836394 Influenza saRNA, high doseExperimentalNot described
Receives: Biological: PF-07836394 Influenza saRNA
PF-07836395 Influenza saRNA, low doseExperimentalNot described
Receives: Biological: PF-07836395 Influenza saRNA
PF-07836395 Influenza saRNA, mid doseExperimentalNot described
Receives: Biological: PF-07836395 Influenza saRNA
PF-07836395 Influenza saRNA, high doseExperimentalNot described
Receives: Biological: PF-07836395 Influenza saRNA
PF-07836396 Influenza saRNA, low doseExperimentalNot described
Receives: Biological: PF-07836396 Influenza saRNA
PF-07836396 Influenza saRNA, mid doseExperimentalNot described
Receives: Biological: PF-07836396 Influenza saRNA
PF-07836396 Influenza saRNA, high doseExperimentalNot described
Receives: Biological: PF-07836396 Influenza saRNA
PF-07867246 Influenza saRNA, mid doseExperimentalNot described
Receives: Biological: PF-07867246 Influenza saRNA
PF-07867246 Influenza saRNA, low doseExperimentalNot described
Receives: Biological: PF-07867246 Influenza saRNA
PF-07867246 Influenza saRNA, high doseExperimentalNot described
Receives: Biological: PF-07867246 Influenza saRNA
PlaceboPlacebo comparatorNot described
Receives: Biological: Placebo
Quadrivalent influenza vaccine (QIV)Active comparatorNot described
Receives: Biological: Quadrivalent influenza vaccine (QIV)
PF-07871987 Influenza saRNA, low doseExperimentalNot described
Receives: Biological: PF-07871987 Influenza saRNA
PF-07871987 Influenza saRNA, mid doseExperimentalNot described
Receives: Biological: PF-07871987 Influenza saRNA
PF-07871987 Influenza saRNA, high doseExperimentalNot described
Receives: Biological: PF-07871987 Influenza saRNA
PF-07914705 Influenza saRNA mid doseExperimentalNot described
Receives: Biological: PF-07914705 Influenza saRNA
PF-07914705 Influenza saRNA, high doseExperimentalNot described
Receives: Biological: PF-07914705 Influenza saRNA
PF-07915048 Influenza saRNA, high doseExperimentalNot described
Receives: Biological: PF-07915048 Influenza saRNA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants reporting local reactions

    Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.

    Measured: For 10 days after vaccination

  2. Percentage of participants reporting systemic events

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries.

    Measured: For 10 days after vaccination

  3. Percentage of participants reporting adverse events

    As elicited by investigational site staff.

    Measured: From vaccination to 4 weeks after vaccination

  4. Percentage of participants reporting serious adverse events

    As elicited by investigational site staff.

    Measured: From vaccination to 6 months after vaccination

  5. Percentage of participants with abnormal hematology and chemistry laboratory values

    As measured at the central laboratory

    Measured: 2 days after vaccination

  6. Percentage of participants with abnormal hematology and chemistry laboratory values

    As measured at the central laboratory

    Measured: 1 week after vaccination

  7. Percentage of participants with grading shifts in hematology and chemistry laboratory assessments

    As measured at the central laboratory.

    Measured: Between baseline and 2 days after vaccination

  8. Percentage of participants with grading shifts in hematology and chemistry laboratory assessments

    As measured at the central laboratory

    Measured: Between baseline and 1 week after vaccination

  9. Percentage of participants with new electrocardiogram (ECG) abnormalities

    ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist

    Measured: 2 days after vaccination

  10. Percentage of participants with new ECG abnormalities

    ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist

    Measured: 1 week after vaccination

Secondary outcomes (4)

  1. Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers

    As measured at the central laboratory

    Measured: At Baseline, and 1-, 2- and 4-weeks after vaccination

  2. Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint

    As measured at the central laboratory

    Measured: At Baseline, and 1-, 2- and 4-weeks after vaccination

  3. Proportion of participants achieving HAI seroconversion for each strain

    As measured at the central laboratory

    Measured: At 1-, 2-, and 4-weeks after vaccination

  4. Proportion of participants with HAI titer >=1:40 for each strain

    As measured at the central laboratory

    Measured: At Baseline, and 1-, 2-, and 4-weeks after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2022
  2. Study start28 Apr 2022
  3. Primary completion4 Aug 2023
  4. Study completion4 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05227001
Sponsor's protocol ID
C4861001
Other IDs
NCT05227001
Status last verified
Mar 2026
First submitted
19 Jan 2022
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PF-07852352 Influenza saRNA 1, PF-07836391 Influenza saRNA and PF-07836394 Influenza saRNA in people with Influenza, Human, run by Pfizer at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants reporting local reactions (time frame: For 10 days after vaccination). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05227001.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

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