a study to learn about the study vaccine (called self-amplifying ribonucleic acid (rna)) for the prevention of influenza

Conditions: Influenza, Human

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. * 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.


Eligibility criteria:
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.

Keywords: grippe flu influenza vaccine rna vaccine self-amplifying