A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza
NCT ID: NCT05052697
Last Updated: 2024-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
1158 participants
INTERVENTIONAL
2021-09-13
2023-01-27
Brief Summary
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Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either:
* 1 of 4 dose levels of mIRV (either A or B Strain),
* 1 of 4 dose levels of bIRV (containing both A and B strains),
* qIRV (at 1 dose level), or
* A licensed quadrivalent influenza vaccine (QIV).
At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2:
* mIRV encoding A strain at dose level 4, or
* mIRV encoding B strain at dose level 4.
Substudy B
This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age:
2-Visit Schedules
* 2 doses of qIRV (at a dose level 1), administered 21 days apart.
* 2 doses of licensed QIV, administered 21 days apart (as a control group)
* A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart.
1-Visit Schedules
* A dose of licensed QIV administered concurrently in the opposite arm with bIRV encoding 2 A strains at dose level combination 1 or 2.
* A dose of bIRV encoding 2 A strains administered concurrently in the opposite arm with a dose of bIRV encoding 2 B strains.at dose level 1.
* A dose of qIRV encoding 2 A strains and 2 B strains at dose level 2 (at one of two possible dose level combinations).
* A dose of qIRV encoding 2 A strains and 2 B strains at dose level 3.
* 1 dose of licensed QIV (as a control group).
Substudy B
In participants 18 to 64 years of age:
-A dose of qIRV encoding 2 A strains and 2 B strains at a dose level combination 1 or 2.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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SSA: mIRV A (dose level 1) + QIV
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: mIRV A (dose level 2) + QIV
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: mIRV A (dose level 3) + QIV
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: mIRV A (dose level 4) + QIV
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: mIRV B (dose level 1) + QIV
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: mIRV B (dose level 2) + QIV
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: mIRV B (dose level 3) + QIV
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: mIRV B (dose level 4) + QIV
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: bIRV AB (dose level combination 1) + QIV
bIRV AB
Intramuscular injection
QIV
Intramuscular injection
SSA: bIRV AB (dose level combination 2) + QIV
bIRV AB
Intramuscular injection
QIV
Intramuscular injection
SSA: bIRV AB (dose level combination 3) + QIV
bIRV AB
Intramuscular injection
QIV
Intramuscular injection
SSA: bIRV AB (dose level combination 4) + QIV
bIRV AB
Intramuscular injection
QIV
Intramuscular injection
SSA: QIV + mIRV A strain (dose level 4)
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: qIRV (dose level 1) + QIV
qIRV
Intramuscular injection
QIV
Intramuscular injection
SSA: QIV + mIRV B strain (dose level 4)
mIRV
Intramuscular injection
QIV
Intramuscular injection
SSB: 2 doses of qIRV (dose level 1), 2-visit schedule
qIRV
Intramuscular injection
SSB: 2 doses of QIV, 2-visit schedule
QIV
Intramuscular injection
SSB: QIV + bIRV AA (dose level combination 1), 2-visit schedule
QIV
Intramuscular injection
bIRV AA
Intramuscular injection
SSB: QIV + bIRV AA (dose level combination 2), 2-visit schedule
QIV
Intramuscular injection
bIRV AA
Intramuscular injection
SSB: QIV + bIRV AA (dose level combination 1), 1-visit schedule
QIV
Intramuscular injection
bIRV AA
Intramuscular injection
SSB: QIV + bIRV AA (dose level combination 2), 1-visit schedule
QIV
Intramuscular injection
bIRV AA
Intramuscular injection
SSB: qIRV (dose level 2, dose combination 1), 1-visit schedule
NOTE: Arm Description has not been entered.
qIRV
Intramuscular injection
SSB: qIRV (dose level 2, dose combination 2), 1-visit schedule
NOTE: Arm Description has not been entered
qIRV
Intramuscular injection
SSB: qIRV (dose level 3), 1-visit schedule
NOTE: Arm Description has not been entered
qIRV
Intramuscular injection
SSB: bIRV AA + bIRV BB (both dose level combination 1), 1-visit schedule
NOTE: Arm Description has not been entered
bIRV AA
Intramuscular injection
bIRV BB
Intramuscular injection
SSB: 1 dose of QIV, 1-visit schedule
NOTE: Arm Description has not been entered
QIV
Intramuscular injection
SSB: qIRV (dose level 1), 1-visit schedule
NOTE: Arm Description has not been entered.
qIRV
Intramuscular injection
SSB: qIRV (dose level 2), 1-visit schedule
NOTE: Arm Description has not been entered.
qIRV
Intramuscular injection
Interventions
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mIRV
Intramuscular injection
bIRV AB
Intramuscular injection
qIRV
Intramuscular injection
QIV
Intramuscular injection
bIRV AA
Intramuscular injection
bIRV BB
Intramuscular injection
Eligibility Criteria
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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.
* Male or female participants 65 to 85 years of age or .Male or female participants 18 to 64 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.
* For participants 65 to 85 years of age at the time of enrollment, receipt of licensed influenza vaccination for the 2021-2022 northern hemisphere season \>4 months (120 days) before study intervention administration.
* 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 SARS-CoV-2 infection, 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 modRNA-platform SARS-CoV-2 vaccine within 60 days of Visit 1
* 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 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.
Substudy B
* 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 SARS-CoV-2 infection, COVID-19, or influenza in the past 14 days known prior to Visit 201
* Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 201 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.
* Any participant who has received or plans to receive a modRNA-platform SARS-CoV-2 vaccine within 28 days of Visit 201
* Any participant who has received licensed influenza vaccination for the 2022-2023 northern hemisphere influenza season.
* Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
* 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 205.
* Prior history of heart disease.
* Any abnormal screening troponin I laboratory value
* Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.
18 Years
85 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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North Alabama Research Center
Athens, Alabama, United States
The Heart Center
Athens, Alabama, United States
Arizona Heart Rhythm Center
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
The Pain Center of Arizona
Phoenix, Arizona, United States
Noble Clinical Research
Tucson, Arizona, United States
Pima Heart and Vascular
Tucson, Arizona, United States
Inland Valley Cardiovascular Center
Murrieta, California, United States
Orange County Heart Institute
Orange, California, United States
Artemis Institute for Clinical Research
Riverside, California, United States
Orange County Research Center
Tustin, California, United States
Pediatrics-Infectious Diseases - Clinical Trials Center at University of Colorado Anschutz Medical C
Aurora, Colorado, United States
UCHealth Heart and Vascular Center - Anschutz Medical Campus
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Yale Cardiology
New Haven, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, United States
Halifax Health Medical Center
Daytona Beach, Florida, United States
NYU Langone Cardiology Associates
Delray Beach, Florida, United States
First Coast Heart & Vascular Center
Fleming Island, Florida, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, United States
Millennium Physician Group
Fort Myers, Florida, United States
Robert B. Pritt, DO
Fort Myers, Florida, United States
Direct Helpers Research Center.
Hialeah, Florida, United States
Best Quality Research,Inc.
Hialeah, Florida, United States
Elixia Infectious Disease, LLC
Hollywood, Florida, United States
First Coast Heart & Vascular Center
Jacksonville, Florida, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, United States
First Coast Cardiovascular Institute
Jacksonville, Florida, United States
Premier Cardiology and Vascular Associates
Maitland, Florida, United States
LMG Research
Miami, Florida, United States
Millennium Clinical Research
Miami, Florida, United States
Optimus U Corporation
Miami, Florida, United States
Suncoast Research Group
Miami, Florida, United States
Schiff Center for Liver Diseases/University of Miami
Miami, Florida, United States
University of Miami Hospital
Miami, Florida, United States
Dr Gerardo A. Polanco, MD
Miami, Florida, United States
Research Institute of South Florida
Miami, Florida, United States
Entrust Clinical Research
Miami, Florida, United States
Jackson Medical Group Cardiac Care
Miami, Florida, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
Central Florida Cardiology Group
Orlando, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
DBC Research USA
Pembroke Pines, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
My Cardiologist
South Miami, Florida, United States
Precision Clinical Research
Sunrise, Florida, United States
Genesis Clinical Research, LLC
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, United States
IACT Health
Columbus, Georgia, United States
IACT Health
Rincon, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
University of Iowa
Iowa City, Iowa, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Heartland Cardiology, LLC
Wichita, Kansas, United States
Centennial Medical Group
Elkridge, Maryland, United States
Associates of Cardiology
Silver Spring, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Pioneer Heart Institute
Lincoln, Nebraska, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
Meridian Clinical Research - 3345 North 107th Street
Omaha, Nebraska, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
Sanjay Vohra, MD, F.A.C.C.
Henderson, Nevada, United States
Wr-Crcn, Llc.
Las Vegas, Nevada, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
Hassman Research Institute
Berlin, New Jersey, United States
Penn Medicine
Somers Point, New Jersey, United States
South Jersey Infectious Disease
Somers Point, New Jersey, United States
NYU Langone - Center for the Prevention of Cardiovascular Disease
New York, New York, United States
NYU Langone Health
New York, New York, United States
Rochester General Hospital Infectious Disease
Rochester, New York, United States
Rochester General Hospital
Rochester, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Upstate Health Care Center-University Cardiovascular Group of Syracuse
Syracuse, New York, United States
SUNY Upstate Medical University Global Health Research Unit
Syracuse, New York, United States
M3-Emerging Medical Research, LLC
Durham, North Carolina, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Aventiv Research Inc.
Columbus, Ohio, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Columbus Cardiovascular Associates, Inc
Columbus, Ohio, United States
Pennsylvania Heart and Vascular Group
Jenkintown, Pennsylvania, United States
Main Street Physician's Care
Little River, South Carolina, United States
Prolato Clinical Research Center
Houston, Texas, United States
DM Clinical Research
Houston, Texas, United States
DM Clinical Research
Humble, Texas, United States
Cedar Health Research
Irving, Texas, United States
Harmony Heart Group
Plano, Texas, United States
Mt Olympus Medical Research
Sugar Land, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Northwest Heart Center
Tomball, Texas, United States
Centricity Research Suffolk Primary Care
Suffolk, Virginia, United States
Sentara BelleHarbour
Suffolk, Virginia, United States
Countries
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References
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Branche A, Mulligan MJ, Maniar A, Puente O, Oladipupo I, Crowther G, Zareba AM, Yi Z, Scully I, Gomme E, Koury K, Kitchin N, Allen PS, Anderson AS, Gurtman A, Lindert K. A Phase 1/2 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of Nucleoside-Modified Messenger RNA Influenza Vaccines in Healthy Adults. Vaccines (Basel). 2025 Apr 3;13(4):383. doi: 10.3390/vaccines13040383.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan: Sub Study A
Document Type: Statistical Analysis Plan: Sub Study B
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4781001
Identifier Type: -
Identifier Source: org_study_id
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