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
2 other identifiers
interventional
440
1 country
24
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Apr 2022
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2022
CompletedFirst Posted
Study publicly available on registry
February 7, 2022
CompletedStudy Start
First participant enrolled
April 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 4, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 4, 2023
CompletedMarch 20, 2026
March 1, 2026
1.3 years
January 19, 2022
March 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
For 10 days after vaccination
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.
For 10 days after vaccination
Percentage of participants reporting adverse events
As elicited by investigational site staff.
From vaccination to 4 weeks after vaccination
Percentage of participants reporting serious adverse events
As elicited by investigational site staff.
From vaccination to 6 months after vaccination
Percentage of participants with abnormal hematology and chemistry laboratory values
As measured at the central laboratory
2 days after vaccination
Percentage of participants with abnormal hematology and chemistry laboratory values
As measured at the central laboratory
1 week after vaccination
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments
As measured at the central laboratory.
Between baseline and 2 days after vaccination
Percentage of participants with grading shifts in hematology and chemistry laboratory assessments
As measured at the central laboratory
Between baseline and 1 week after vaccination
Percentage of participants with new electrocardiogram (ECG) abnormalities
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
2 days after vaccination
Percentage of participants with new ECG abnormalities
ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
1 week after vaccination
Secondary Outcomes (4)
Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers
At Baseline, and 1-, 2- and 4-weeks after vaccination
Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint
At Baseline, and 1-, 2- and 4-weeks after vaccination
Proportion of participants achieving HAI seroconversion for each strain
At 1-, 2-, and 4-weeks after vaccination
Proportion of participants with HAI titer >=1:40 for each strain
At Baseline, and 1-, 2-, and 4-weeks after vaccination
Study Arms (26)
PF-07852352 Influenza saRNA, low dose
EXPERIMENTALPF-07852352 Influenza saRNA, mid dose
EXPERIMENTALPF-07852352 Influenza saRNA, high dose
EXPERIMENTALPF-07836391 Influenza saRNA, low dose
EXPERIMENTALPF-07836391 Influenza saRNA, mid dose
EXPERIMENTALPF-07836391 Influenza saRNA, high dose
EXPERIMENTALPF-07836394 Influenza saRNA, low dose
EXPERIMENTALPF-07836394 Influenza saRNA, mid dose
EXPERIMENTALPF-07836394 Influenza saRNA, high dose
EXPERIMENTALPF-07836395 Influenza saRNA, low dose
EXPERIMENTALPF-07836395 Influenza saRNA, mid dose
EXPERIMENTALPF-07836395 Influenza saRNA, high dose
EXPERIMENTALPF-07836396 Influenza saRNA, low dose
EXPERIMENTALPF-07836396 Influenza saRNA, mid dose
EXPERIMENTALPF-07836396 Influenza saRNA, high dose
EXPERIMENTALPF-07867246 Influenza saRNA, mid dose
EXPERIMENTALPF-07867246 Influenza saRNA, low dose
EXPERIMENTALPF-07867246 Influenza saRNA, high dose
EXPERIMENTALPlacebo
PLACEBO COMPARATORQuadrivalent influenza vaccine (QIV)
ACTIVE COMPARATORPF-07871987 Influenza saRNA, low dose
EXPERIMENTALPF-07871987 Influenza saRNA, mid dose
EXPERIMENTALPF-07871987 Influenza saRNA, high dose
EXPERIMENTALPF-07914705 Influenza saRNA mid dose
EXPERIMENTALPF-07914705 Influenza saRNA, high dose
EXPERIMENTALPF-07915048 Influenza saRNA, high dose
EXPERIMENTALInterventions
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Intramuscular injection
Eligibility Criteria
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.
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (24)
Arizona Heart Rhythm Center
Phoenix, Arizona, 85016, United States
Hope Research Institute
Phoenix, Arizona, 85018, United States
The Pain Center of Arizona
Phoenix, Arizona, 85018, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Finlay Medical Research
Greenacres City, Florida, 33467, United States
Advanced Pharma CR, LLC
Miami, Florida, 33147, United States
Miami Clinical Research
Miami, Florida, 33155, United States
Mount Sinai Hospital
Miami Beach, Florida, 33140, United States
Panax Clinical Research
Miami Lakes, Florida, 33014, United States
Pines Care Research Center, LLC
Pembroke Pines, Florida, 33024, United States
Pinnacle Health Care Center
Pembroke Pines, Florida, 33024, United States
Comprehensive Cardiology Consultants
Pembroke Pines, Florida, 33028, United States
Great Lakes Clinical Trials - Andersonville
Chicago, Illinois, 60640, United States
Pioneer Heart Institute
Lincoln, Nebraska, 68506, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134, United States
NYU Langone Health
New York, New York, 10016, United States
SUNY Upstate Medical University Global Health Laboratory
Syracuse, New York, 13210, United States
SUNY Upstate Medical University Institute for Global Health
Syracuse, New York, 13215, United States
SUNY Upstate Medical University
Syracuse, New York, 13215, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Benchmark Research
Austin, Texas, 78705, United States
Eric S. Tiblier, MD
Austin, Texas, 78705, United States
DM Clinical Research, Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2022
First Posted
February 7, 2022
Study Start
April 28, 2022
Primary Completion
August 4, 2023
Study Completion
August 4, 2023
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share
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.