Loading clinical trials...

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

COMPLETEDPHASE1

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

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

NCT05227001•Pfizer

View on ClinicalTrials.gov

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

Age

18 - 49 years

Sex

ALL

Healthy Volunteers

Yes

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.
+9 more criteria

Locations (24)

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

Key Dates

Start Date

April 28, 2022

Primary Completion Date

August 4, 2023

Completion Date

August 4, 2023

Last Updated

March 20, 2026

Enrollment

440

ACTUAL participants

Conditions

Influenza, Human

Interventions

PF-07852352 Influenza saRNA 1

BIOLOGICAL

PF-07836391 Influenza saRNA

BIOLOGICAL

PF-07836394 Influenza saRNA

BIOLOGICAL

PF-07836395 Influenza saRNA

BIOLOGICAL

PF-07836396 Influenza saRNA

BIOLOGICAL

PF-07867246 Influenza saRNA

BIOLOGICAL

Placebo

BIOLOGICAL

Quadrivalent influenza vaccine (QIV)

BIOLOGICAL

PF-07871987 Influenza saRNA

BIOLOGICAL

PF-07914705 Influenza saRNA

BIOLOGICAL

PF-07915048 Influenza saRNA

BIOLOGICAL

Covid-19 and Influenza Oral Vaccine Study

NCT06355232

covid19 InfectionInfluenza, Human

View study

ACTIVE_NOT_RECRUITINGPHASE1

Phase I Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

NCT06622590

Influenza, HumanInfluenza a+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Covid-19 and Influenza Oral Vaccine Study

Phase I Clinical Trial of Quadrivalent Influenza Virus Split Vaccine

A Study on the Safety, Reactogenicity and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

Safety and Immunogenicity Study of Self-Amplifying RNA Pandemic Influenza Vaccine in Adults

A Study to Assess the Safety and Immune Response of a Vaccine Against Influenza in Healthy Younger and Older Adults

Functional Consequences of T-bet Expression in Flu-specific Memory B Cells After Live Attenuated Influenza Vaccine (LAIV)