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

Completed · Phase 1 · Has a placebo group

Conditions studied: Influenza, Human

In brief

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.

Key facts

Study ID

NCT05227001

Run by

Pfizer

People needed

440

Starts

2022-04-28

Expected to finish

2023-08-04

Last updated by the study team

2026-03-20

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Arizona Heart Rhythm Center — Phoenix, Arizona, United States
• Hope Research Institute — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Finlay Medical Research — Greenacres City, Florida, United States
• Advanced Pharma CR, LLC — Miami, Florida, United States
• Miami Clinical Research — Miami, Florida, United States
• Mount Sinai Hospital — Miami Beach, Florida, United States
• Panax Clinical Research — Miami Lakes, Florida, United States
• Pines Care Research Center, LLC — Pembroke Pines, Florida, United States
• Pinnacle Health Care Center — Pembroke Pines, Florida, United States
• Comprehensive Cardiology Consultants — Pembroke Pines, Florida, United States
• Great Lakes Clinical Trials - Andersonville — Chicago, Illinois, United States
• Pioneer Heart Institute — Lincoln, Nebraska, United States
• Velocity Clinical Research, Omaha — Omaha, Nebraska, United States
• NYU Langone Health — New York, New York, United States
• SUNY Upstate Medical University Global Health Laboratory — Syracuse, New York, United States
• SUNY Upstate Medical University Institute for Global Health — Syracuse, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Coastal Carolina Research Center — North Charleston, South Carolina, United States
• Benchmark Research — Austin, Texas, United States
• Eric S. Tiblier, MD — Austin, Texas, United States
• DM Clinical Research, Martin Diagnostic Clinic — Tomball, Texas, United States

Full record on ClinicalTrials.gov

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