A Study To Learn About The Study Vaccine (Called Self-Amplifying Ribonucleic Acid (RNA)) For The Prevention of Influenza
NCT ID: NCT05227001
Last Updated: 2023-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
442 participants
INTERVENTIONAL
2022-04-28
2023-08-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
NCT05540522
A Safety, Reactogenicity, and Immunogenicity Study of mRNA-1073 (COVID-19/Influenza) Vaccine in Adults 18 to 75 Years Old
NCT05375838
A Study of mRNA-1020 and mRNA-1030 Seasonal Influenza Vaccines in Healthy Adults
NCT05333289
A Study to Find and Confirm the Dose and Assess Safety, Reactogenicity and Immune Response of a Vaccine Against Pandemic H5N1 Influenza Virus in Healthy Younger and Older Adults
NCT06382311
A Study of mRNA-1011.1, mRNA-1011.2, and mRNA-1012.1 Candidate Seasonal Influenza Vaccines in Healthy Adults
NCT05827068
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PF-07852352 Influenza saRNA, low dose
PF-07852352 Influenza saRNA 1
Intramuscular injection
PF-07852352 Influenza saRNA, mid dose
PF-07852352 Influenza saRNA 1
Intramuscular injection
PF-07852352 Influenza saRNA, high dose
PF-07852352 Influenza saRNA 1
Intramuscular injection
PF-07836391 Influenza saRNA, low dose
PF-07836391 Influenza saRNA
Intramuscular injection
PF-07836391 Influenza saRNA, mid dose
PF-07836391 Influenza saRNA
Intramuscular injection
PF-07836391 Influenza saRNA, high dose
PF-07836391 Influenza saRNA
Intramuscular injection
PF-07836394 Influenza saRNA, low dose
PF-07836394 Influenza saRNA
Intramuscular injection
PF-07836394 Influenza saRNA, mid dose
PF-07836394 Influenza saRNA
Intramuscular injection
PF-07836394 Influenza saRNA, high dose
PF-07836394 Influenza saRNA
Intramuscular injection
PF-07836395 Influenza saRNA, low dose
PF-07836395 Influenza saRNA
Intramuscular injection
PF-07836395 Influenza saRNA, mid dose
PF-07836395 Influenza saRNA
Intramuscular injection
PF-07836395 Influenza saRNA, high dose
PF-07836395 Influenza saRNA
Intramuscular injection
PF-07836396 Influenza saRNA, low dose
PF-07836396 Influenza saRNA
Intramuscular injection
PF-07836396 Influenza saRNA, mid dose
PF-07836396 Influenza saRNA
Intramuscular injection
PF-07836396 Influenza saRNA, high dose
PF-07836396 Influenza saRNA
Intramuscular injection
PF-07867246 Influenza saRNA, mid dose
PF-07867246 Influenza saRNA
Intramuscular injection
PF-07867246 Influenza saRNA, low dose
PF-07867246 Influenza saRNA
Intramuscular injection
PF-07867246 Influenza saRNA, high dose
PF-07867246 Influenza saRNA
Intramuscular injection
Placebo
Placebo
Intramuscular injection
Quadrivalent influenza vaccine (QIV)
Quadrivalent influenza vaccine (QIV)
Intramuscular injection
PF-07871987 Influenza saRNA, low dose
PF-07871987 Influenza saRNA
Intramuscular injection
PF-07871987 Influenza saRNA, mid dose
PF-07871987 Influenza saRNA
Intramuscular injection
PF-07871987 Influenza saRNA, high dose
PF-07871987 Influenza saRNA
Intramuscular injection
PF-07914705 Influenza saRNA mid dose
PF-07914705 Influenza saRNA
Intramuscular injection
PF-07914705 Influenza saRNA, high dose
PF-07914705 Influenza saRNA
Intramuscular injection
PF-07915048 Influenza saRNA, high dose
PF-07915048 Influenza saRNA
Intramuscular injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PF-07852352 Influenza saRNA 1
Intramuscular injection
PF-07836391 Influenza saRNA
Intramuscular injection
PF-07836394 Influenza saRNA
Intramuscular injection
PF-07836395 Influenza saRNA
Intramuscular injection
PF-07836396 Influenza saRNA
Intramuscular injection
PF-07867246 Influenza saRNA
Intramuscular injection
Placebo
Intramuscular injection
Quadrivalent influenza vaccine (QIV)
Intramuscular injection
PF-07871987 Influenza saRNA
Intramuscular injection
PF-07914705 Influenza saRNA
Intramuscular injection
PF-07915048 Influenza saRNA
Intramuscular injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
49 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Meridian Clinical Research, LLC
Omaha, 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
Tomball, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C4861001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.