A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
A PHASE 3, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA COMPARED TO LICENSED INACTIVATED INFLUENZA VACCINE IN HEALTHY ADULTS 18 YEARS OF AGE OR OLDER
2 other identifiers
interventional
45,789
6 countries
321
Brief Summary
This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2022
321 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2022
CompletedStudy Start
First participant enrolled
September 12, 2022
CompletedFirst Posted
Study publicly available on registry
September 14, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2024
CompletedResults Posted
Study results publicly available
May 8, 2025
CompletedMay 8, 2025
April 1, 2025
1.5 years
September 8, 2022
March 11, 2025
April 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
LCI was defined as influenza infection confirmed through through reverse transcription- polymerase chain reaction (RT-PCR) or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode of Laboratory-Confirmed Influenza (LCI) Cases With Associated Per-Protocol Influenza-Like Illness (ILI) Caused by Any Strain at Least 14 Days After Vaccination: >= 65 Years
LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptoms concurrently with at least 1 systemic symptoms. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.
Day 15 up to primary surveillance cut-off (approximately 1 year)
Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
From Day 1 to Day 7 after study vaccination
Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years
Local reactions included redness, swelling and pain at the injection site and were recorded by participants in an e-diary. All local reactions were graded based on Center for Biologics Evaluation and Research (CBER) toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any local reaction and any grade.
From Day 1 to Day 7 after study vaccination
Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
From Day 1 to Day 7 after study vaccination
Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years
Systemic events (vomiting, diarrhoea, headache, Fatigue/tiredness, chills, new or worsened muscle pain and joint pain) were recorded by participants in an e-diary. All systemic events were graded based on CBER toxicity guidelines as Grade 1 (Mild), Grade 2 (Moderate), Grade 3 (Severe) and Grade 4 (potentially life-threatening). In this outcome measure data is reported for any systemic reaction and any grade.
From Day 1 to Day 7 after study vaccination
Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
From study vaccination on Day 1 through 4 weeks after study vaccination
Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
From study vaccination on Day 1 through 4 weeks after study vaccination
Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years
An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Results excluded local reactions and systemic events data.
From study vaccination on Day 1 through 4 weeks after study vaccination
Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.
From Day 1 up to 6 months after vaccination
Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.
From Day 1 up to 6 months after vaccination
Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years
An SAE was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria - resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect.
From Day 1 up to 6 months after vaccination
Secondary Outcomes (46)
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: 18-64 Years
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode of LCI Cases With Associated Per-Protocol ILI Caused by All Matched Strains at Least 14 Days After Vaccination: >=65 Years
Day 15 up to primary surveillance cut-off (approximately 1 year)
Percentage of Participants Reporting First Episode of Culture Confirmed Influenza (CCI) With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
Day 15 to surveillance cut-off (approximately 6 months)
Percentage of Participants Reporting First Episode of CCI With Associated Per-Protocol ILI Caused by Any Strain at Least 14 Days After Vaccination: >=65 Years
Day 15 up to primary surveillance cut-off (approximately 1 year)
Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified Centers for Disease Control and Prevention (CDC) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years
Day 15 to surveillance cut-off (approximately 6 months)
- +41 more secondary outcomes
Study Arms (4)
Quadrivalent influenza modRNA vaccine, 18 through 64 years of age
EXPERIMENTALQuadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age
Quadrivalent influenza vaccine, 18 through 64 years of age
ACTIVE COMPARATORLicensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age
Quadrivalent influenza modRNA vaccine, ≥65 years of age
EXPERIMENTALQuadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age
Quadrivalent influenza vaccine, ≥65 years of age
ACTIVE COMPARATORLicensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age
Interventions
Quadrivalent influenza modRNA vaccine (single dose)
Licensed quadrivalent influenza vaccine (single dose)
Eligibility Criteria
You may qualify if:
- Male or female participants ≥18 years of age at Visit 1 (Day 1).
- Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
- Capable of giving signed informed consent as described in the protocol, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
You may not qualify if:
- 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 any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
- 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.
- Allergy to egg proteins (egg or egg products) or chicken proteins.
- Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Receipt of blood/plasma products or immunoglobulin from 60 days before study intervention administration, or planned receipt throughout the study.
- Vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration, or ongoing receipt of chronic antiviral therapy with activity against influenza.
- Any participant who has received or plans to receive a modRNA-platform SARS CoV-2 vaccine within 14 days before or after study vaccination at Visit 1.
- Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study.
- Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (321)
North Alabama Research Center
Athens, Alabama, 35611, United States
St. Vincent's Birmingham Hospital
Birmingham, Alabama, 35205, United States
Accel Research Sites Network - Birmingham Clinical Research Unit
Birmingham, Alabama, 35216, United States
Ross Bridge Medical Practice, LLC-CCT Research
Birmingham, Alabama, 35226, United States
SEC Clinical Research
Dothan, Alabama, 36305, United States
Lakeview Clinical Research
Guntersville, Alabama, 35976, United States
Medical Affiliated Research Center
Huntsville, Alabama, 35801, United States
Lenzmeier Family Medicine/CCT Research
Glendale, Arizona, 85308, United States
Aventiv Research
Mesa, Arizona, 85206, United States
Desert Clinical Research/ CCT Research
Mesa, Arizona, 85213, United States
HOPE Research Institute
Phoenix, Arizona, 85018, United States
The Pain Center of Arizona
Phoenix, Arizona, 85018, United States
HOPE Research Institute - Phoenix
Phoenix, Arizona, 85023, United States
HOPE Research Institute
Phoenix, Arizona, 85023, United States
Foothills Research Center/ CCT Research
Phoenix, Arizona, 85044, United States
Epic Medical Research - Surprise
Surprise, Arizona, 85378, United States
Fiel Family and Sports Medicine, PC/CCT Research
Tempe, Arizona, 85283, United States
HOPE Research Institute
Tempe, Arizona, 85284, United States
Noble Clinical Research
Tucson, Arizona, 85704, United States
Baptist Health Center For Clinical Research
Little Rock, Arkansas, 72205, United States
Applied Research Center of Arkansas
Little Rock, Arkansas, 72212, United States
Anaheim Clinical Trials
Anaheim, California, 92801, United States
Velocity Clinical Research, San Bernardino
Banning, California, 92220, United States
Benchmark Research
Colton, California, 92324, United States
Ascada Health PC dba Ascada Research
Fullerton, California, 92835, United States
Marvel Clinical Research
Huntington Beach, California, 92647, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Velocity Clinical Research, San Diego
La Mesa, California, 91942, United States
Orange County Research Center
Lake Forest, California, 92630, United States
Ark Clinical Research
Long Beach, California, 90815, United States
Kaiser Permanente
Los Angeles, California, 90027, United States
Velocity Clinical Research, Westlake
Los Angeles, California, 90057, United States
Velocity Clinical Research, North Hollywood
North Hollywood, California, 91606, United States
Center for Clinical Trials, LLC
Paramount, California, 90723, United States
Empire Clinical Research
Pomona, California, 91767, United States
Paradigm Clinical Research Centers, Inc
Redding, California, 96001, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Benchmark Research
Sacramento, California, 95864, United States
Artemis Institute for Clinical Research
San Diego, California, 92103, United States
Wr-McCr, Llc
San Diego, California, 92120, United States
California Research Foundation
San Diego, California, 92123, United States
Encompass Clinical Research
Spring Valley, California, 91978, United States
Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
Toluca Lake, California, 91602, United States
Collaborative Neuroscience Research, LLC
Torrance, California, 90504, United States
Ark Clinical Research - Tustin
Tustin, California, 92780, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Lynn Institute of Denver
Aurora, Colorado, 80012, United States
Tekton Research, LLC.
Fort Collins, Colorado, 80525, United States
Tekton Research, LLC.
Longmont, Colorado, 80501, United States
Paradigm Clinical Research Centers, Inc
Wheat Ridge, Colorado, 80033, United States
New England Research Associates, LLC
Bridgeport, Connecticut, 06606, United States
Clinical Research Consulting
Milford, Connecticut, 06460, United States
New Haven Clinical Research Unit
New Haven, Connecticut, 06511, United States
Yale Cardiology
New Haven, Connecticut, 06519, United States
Yale University School of Medicine
New Haven, Connecticut, 06519, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
Washington Health Institute
Washington D.C., District of Columbia, 20017, United States
JEM Research Institute
Atlantis, Florida, 33462, United States
Tampa Bay Medical Research
Clearwater, Florida, 33761, United States
Alliance for Multispecialty Research, LLC
Coral Gables, Florida, 33134, United States
Universal Axon Clinical Research, LLC
Doral, Florida, 33166, United States
Fleming Island Center for Clinical Research
Fleming Island, Florida, 32003, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, 33308, United States
Alliance for Multispecialty Research, LLC
Fort Myers, Florida, 33912, United States
Robert B. Pritt, DO
Fort Myers, Florida, 33912, United States
Best Quality Research,Inc.
Hialeah, Florida, 33016, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
Jacksonville, Florida, 32256, United States
Health Awareness
Jupiter, Florida, 33458, United States
Wr-Msra.Llc
Lake City, Florida, 32055, United States
JEM Research Institute
Lake Worth, Florida, 33462, United States
Accel Research Sites Network - Lakeland Clinical Research Unit
Lakeland, Florida, 33803, United States
Accel Research Sites - St. Petersburg Clinical Research Unit
Largo, Florida, 33777, United States
Accel Research Sites Network - Maitland Clinical Research Unit
Maitland, Florida, 32751, United States
Care Research - West Flagler Street
Miami, Florida, 33130, United States
Gerardo Polanco, MD
Miami, Florida, 33156, United States
Entrust Clinical Research
Miami, Florida, 33176, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, 33176, United States
Palm Springs Community Health Center
Miami Lakes, Florida, 33014, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801, United States
Headlands Research Orlando
Orlando, Florida, 32819, United States
Innovation Medical Research Center
Palmetto Bay, Florida, 33157, United States
DBC Research USA
Pembroke Pines, Florida, 33029, United States
United Medical Research
Port Orange, Florida, 32127, United States
Genesis Clinical Research, LLC
Tampa, Florida, 33603, United States
Angels Clinical Research Institute
Tampa, Florida, 33614, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789, United States
Centricity Research Columbus Georgia Multispecialty
Columbus, Georgia, 31904, United States
IACT Health
Rincon, Georgia, 31326, United States
Centricity Research Rincon Pulmonology
Rincon, Georgia, 31406, United States
AGILE Clinical Research Trials, LLC
Sandy Springs, Georgia, 30328, United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328, United States
CenExel iResearch, LLC
Savannah, Georgia, 31405, United States
Javara - Privia Medical Group Georgia - Savannah
Savannah, Georgia, 31406, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, 31406, United States
Clinical Research Atlanta
Stockbridge, Georgia, 30281, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
East-West Medical Research Institute
Honolulu, Hawaii, 96814, United States
Clinical Research Prime
Idaho Falls, Idaho, 83404, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Koch Family Medicine
Morton, Illinois, 61550, United States
Accellacare - DuPage
Oak Lawn, Illinois, 60453, United States
MediSphere Medical Research Center - Evansville - West Franklin Street
Evansville, Indiana, 47712, United States
MediSphere Medical Research Center - EAST
Evansville, Indiana, 47714, United States
Velocity Clinical Research, Valparaiso
Valparaiso, Indiana, 46383, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa, 51106, United States
Alliance for Multispecialty Research, LLC
Newton, Kansas, 67114, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67205, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, 67207, United States
Alliance for Multispecialty Research, LLC
Lexington, Kentucky, 40509, United States
Versailles Family Medicine / CCT Research
Versailles, Kentucky, 40383, United States
MedPharmics, LLC
Lafayette, Louisiana, 70508, United States
DelRicht Research
New Orleans, Louisiana, 70115, United States
Alliance for Multispecialty Research, LLC
New Orleans, Louisiana, 70119, United States
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, 71101, United States
Pharmaron
Baltimore, Maryland, 21201, United States
Advanced Primary and Geriatric Care - CCT Research
Rockville, Maryland, 20850, United States
Jadestone Clinical Research
Silver Spring, Maryland, 20904, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
ActivMed Practices and Research
Methuen, Massachusetts, 01844, United States
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01655, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Ascension St. John Hospital
Grosse Pointe Woods, Michigan, 48236, United States
Revival Research Institute, LLC
Sterling Heights, Michigan, 48312, United States
Oakland Medical Research
Troy, Michigan, 48085, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
Clinical Research Professionals
Chesterfield, Missouri, 63005, United States
Bio-Kinetic Clinical Applications, LLD dba QPS-MO
Springfield, Missouri, 65802, United States
QPS Bio-Kinetic Clinical Applications (Patient Screening Only)
Springfield, Missouri, 65807, United States
Saint Louis University Center for Vaccine Development
St Louis, Missouri, 63104, United States
Sundance Clinical Research
St Louis, Missouri, 63141, United States
Bozeman Health Deaconess Hospital
Bozeman, Montana, 59715, United States
Methodist Physicians Clinic/CCT Research
Fremont, Nebraska, 68025, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803, United States
Be Well Clinical Studies
Lincoln, Nebraska, 68516, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, 68701, United States
Quality Clinical Research
Omaha, Nebraska, 68114, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, 68134, United States
Papillion Research Center/CCT Research
Papillion, Nebraska, 68046, United States
Excel Clinical Research, LLC
Las Vegas, Nevada, 89109, United States
Santa Rosa Medical Centers of Nevada / CCT Research
Las Vegas, Nevada, 89119, United States
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, 03801, United States
David Jurist Research Building
Hackensack, New Jersey, 07601, United States
Hackensack University Medical Center Medical Plaza
Hackensack, New Jersey, 07601, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
South Jersey Infectious Disease
Somers Point, New Jersey, 08244, United States
Albuquerque Clinical Trials, Inc.
Albuquerque, New Mexico, 87102, United States
Velocity Clinical Research, Albuquerque
Albuquerque, New Mexico, 87107, United States
Smith Allergy & Asthma Specialists
Horseheads, New York, 14845, United States
NYU Langone Health
New York, New York, 10016, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Velocity Clinical Research, Vestal
Vestal, New York, 13850, United States
Accellacare - Cary
Cary, North Carolina, 27518, United States
Accellacare - Charlotte
Charlotte, North Carolina, 28211, United States
Carolina Institute for Clinical Research
Fayetteville, North Carolina, 28303, United States
PharmQuest Life Sciences, LLC
Greensboro, North Carolina, 27408, United States
Accellacare - Hickory
Hickory, North Carolina, 28601, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Accellacare - Raleigh
Raleigh, North Carolina, 27609, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, 27612, United States
Accellacare - Rocky Mount
Rocky Mount, North Carolina, 27804, United States
Accellacare - Salisbury
Salisbury, North Carolina, 28144, United States
Accellacare - Wilmington
Wilmington, North Carolina, 28401, United States
Trial Management Associates - Wilmington - Floral Parkway
Wilmington, North Carolina, 28403, United States
Accellacare - Winston-Salem
Winston-Salem, North Carolina, 27103, United States
Plains Clinical Research Center
Fargo, North Dakota, 58104, United States
Plains Medical Clinic, LLC
Fargo, North Dakota, 58104, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Meridian Clinical Research, LLC
Cincinnati, Ohio, 45219, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Senders Pediatrics
Cleveland, Ohio, 44121, United States
Velocity Clinical Research, Cleveland
Cleveland, Ohio, 44122, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, 43213, United States
Dayton Clinical Research
Dayton, Ohio, 45409, United States
WellNow Urgent Care & Research
Dayton, Ohio, 45424, United States
PriMED Clinical Research
Dayton, Ohio, 45429, United States
Tekton Research, LLC.
Edmond, Oklahoma, 73013, United States
Tekton Research, LLC.
Moore, Oklahoma, 73160, United States
Lynn Institute of Norman
Norman, Oklahoma, 73072, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Tekton Research, LLC.
Yukon, Oklahoma, 73099, United States
Velocity Clinical Research, Medford
Medford, Oregon, 97504, United States
Kaiser Permanente Northwest Center for Health Research
Portland, Oregon, 97227, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18102, United States
Capital Area Research, LLC
Camp Hill, Pennsylvania, 17011, United States
Central Erie Primary Care
Erie, Pennsylvania, 16508, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, 02818, United States
Velocity Clinical Research, Anderson
Anderson, South Carolina, 29621, United States
Pharmacorp Clinical Trials
Charleston, South Carolina, 29412, United States
Velocity Clinical Research, Columbia
Columbia, South Carolina, 29204, United States
Velocity Clinical Research, Gaffney
Gaffney, South Carolina, 29340, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Main Street Physician's Care
Little River, South Carolina, 29566, United States
Clinical Trials of South Carolina
Moncks Corner, South Carolina, 29461, United States
Trial Management Associates
Myrtle Beach, South Carolina, 29572, United States
Coastal Carolina Research Center
North Charleston, South Carolina, 29405, United States
Velocity Clinical Research, Spartanburg
Spartanburg, South Carolina, 29303, United States
Velocity Clinical Research, Union
Union, South Carolina, 29379, United States
Internal Medicine and Pediatric Associates of Bristol
Bristol, Tennessee, 37620, United States
WR-Clinsearch, LLC
Chattanooga, Tennessee, 37421, United States
Holston Medical Group
Kingsport, Tennessee, 37660, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, 37909, United States
New Phase Research and Development
Knoxville, Tennessee, 37909, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, 37912, United States
Accellacare US Inc., d/b/a Accellacare of Knoxville
Knoxville, Tennessee, 37938, United States
Clinical Neuroscience Solutions Inc.
Memphis, Tennessee, 38119, United States
Elligo Clinical Research Center
Austin, Texas, 78704, United States
Benchmark Research
Austin, Texas, 78705, United States
Tekton Research, LLC.
Austin, Texas, 78745, United States
Orion Clinical Research
Austin, Texas, 78759, United States
Velocity Clinical Research, Austin
Austin, Texas, 78759, United States
Headlands Research - Brownsville
Brownsville, Texas, 78526, United States
WR-Global Medical Research, LLC
Dallas, Texas, 75224, United States
DFW Clinical Research
Dallas, Texas, 75234, United States
North Texas Infectious Diseases Consultants, P.A
Dallas, Texas, 75246, United States
Epic Medical Research - DeSoto
DeSoto, Texas, 75115, United States
Proactive Clinical Research, LLC
Edinburg, Texas, 78539, United States
Benchmark Research
Fort Worth, Texas, 76135, United States
Texas Health Family Care
Fort Worth, Texas, 76135, United States
Allure Health
Friendswood, Texas, 77546, United States
Trio Clinical Trials
Houston, Texas, 77008, United States
Juno Research
Houston, Texas, 77040, United States
Prolato Clinical Research Center
Houston, Texas, 77054, United States
DM Clinical Research - Bellaire
Houston, Texas, 77081, United States
Santa Clara Family Clinic
Houston, Texas, 77087, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research
Humble, Texas, 77338, United States
Andres Garcia Zuniga, M.D., P.A.
Laredo, Texas, 78041, United States
SMS Clinical Research
Mesquite, Texas, 75149, United States
AIM Trials, LLC
Plano, Texas, 75093, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, 78229, United States
IMA Clinical Research San Antonio
San Antonio, Texas, 78229, United States
Tekton Research, LLC.
San Antonio, Texas, 78229, United States
Javara - Privia Medical Group North Texas - Stephenville
Stephenville, Texas, 76401, United States
Sugar Lakes Family Practice, PA
Sugar Land, Texas, 77479, United States
DM Clinical Research, Martin Diagnostic Clinic
Tomball, Texas, 77375, United States
Northwest Houston Heart Center
Tomball, Texas, 77375, United States
Crossroads Clinical Research
Victoria, Texas, 77901, United States
Cope Family Medicine / CCT Research
Bountiful, Utah, 84010, United States
South Ogden Family Medicine/ CCT Research
Ogden, Utah, 84405, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
Olympus Family Medicine/CCT Research
Salt Lake City, Utah, 84117, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, 84121, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, 84095, United States
Springville Dermatology - Springville/CCT Research
Springville, Utah, 84663, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, 84088, United States
Clinical Alliance for Research and Education - Infectious Diseases (CARE-ID), LLC
Annandale, Virginia, 22003, United States
Charlottesville Medical Research
Charlottesville, Virginia, 22911, United States
Virginia Research Center
Midlothian, Virginia, 23114, United States
Health Research of Hampton Roads, Inc.
Newport News, Virginia, 23606, United States
Alliance for Multispecialty Research, LLC
Norfolk, Virginia, 23502, United States
Meridian Clinical Research LLC
Portsmouth, Virginia, 23703, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
Centricity Research Suffolk Primary Care
Suffolk, Virginia, 23435, United States
EvergreenHealth Medical Center
Kirkland, Washington, 98034, United States
EvergreenHealth
Kirkland, Washington, 98034, United States
Rainier Clinical Research Center
Renton, Washington, 98057, United States
Kaiser Permanente Washington Health Research Institute (KPWHRI)
Seattle, Washington, 98101, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101, United States
Seattle Clinical Research Center
Seattle, Washington, 98105, United States
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, 53226, United States
Fundacion Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ, Argentina
Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
San Miguel de Tucumán, Tucumán Province, 4000, Argentina
Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
Buenos Aires, 1426, Argentina
Enroll SpA
Santiago, Santiago Metropolitan, 7500587, Chile
Centro Skin Med Limitada
Santiago, Santiago Metropolitan, 7580206, Chile
CECIM
Santiago, Santiago Metropolitan, 8330336, Chile
Pacific Clinical Research Network - Rotorua
Rotorua, Bay of Plenty, 3010, New Zealand
P3 Research - Tauranga
Tauranga, Bay of Plenty, 3110, New Zealand
Pacific Clinical Research Network - Forte
Christchurch, Canterbury, 8013, New Zealand
P3 Research - Hawke's Bay
Hastings, Hawke's Bay Region, 4122, New Zealand
Lakeland Clinical Trials Waikato
Hamilton, Waikato Region, 3200, New Zealand
Lakeland Clinical Trials Wellington
Upper Hutt, Wellington Region, 5018, New Zealand
Southern Clinical Trials Totara
Auckland, 0600, New Zealand
Optimal Clinical Trials North
Auckland, 0632, New Zealand
Optimal Clinical Trials
Auckland, 1010, New Zealand
Southern Clinical Trials Tasman
Nelson, 7011, New Zealand
P3 Research - Wellington
Wellington, 6021, New Zealand
West Visayas State University Medical Center
Iloilo City, Iloilo, 5000, Philippines
Tropical Disease Foundation
Makati City, National Capital Region, 1230, Philippines
Health Cube Medical Clinics
Mandaluyong, National Capital Region, 1552, Philippines
Mary Johnston Hospital
Manila, National Capital Region, 1012, Philippines
Lung Center of the Philippines
Quezon City, National Capital Region, 1100, Philippines
Far Eastern University Nicanor Reyes Medical Foundation
Quezon City, National Capital Region, 1118, Philippines
Adventist Hospital Palawan
Puerto Princesa City, Palawan, 5300, Philippines
De La Salle Medical and Health Sciences Institute
Dasmariñas, 4114, Philippines
De La Salle Health Sciences Institute
Dasmariñas, Philippines
Iloilo Doctors' Hospital
Iloilo City, 5000, Philippines
St. Paul's Hospital of Iloilo, Inc.
Iloilo City, 5000, Philippines
Philippine General Hospital
Manila, 1000, Philippines
Synergy Biomed Research Institute
East London, Eastern Cape, 5241, South Africa
Phoenix Pharma
Port Elizabeth, Eastern Cape, 6001, South Africa
Iatros International
Bloemfontein, Free State, 9301, South Africa
Josha Research
Bloemfontein, Free State, 9301, South Africa
Worthwhile Clinical Trials
Benoni, Gauteng, 1500, South Africa
REIMED Reiger Park
Boksburg, Gauteng, 1459, South Africa
Soweto Clinical Trials Centre
Johannesburg, Gauteng, 1818, South Africa
Clinresco Centres
Kempton Park, Gauteng, 1619, South Africa
Ubuntu Clinical Research - Krugersdorp
Krugersdorp, Gauteng, 1739, South Africa
Ubuntu Clinical Research - Lenasia
Lenasia, Gauteng, 1827, South Africa
Zinakekele Medicall Centre
Moloto, Gauteng, 1022, South Africa
Emmed Research
Pretoria, Gauteng, 0002, South Africa
Setshaba Research Centre
Pretoria, Gauteng, 0152, South Africa
Global Clinical Trials
Pretoria, Gauteng, 0157, South Africa
Botho Ke Bontle Health Services
Pretoria, Gauteng, 0184, South Africa
Jongaie Research
Pretoria West, Gauteng, 0183, South Africa
Wits Clinical Research
Soweto, Gauteng, 2013, South Africa
Synexus Watermeyer Clinical Research Centre
Val de Grace, Gauteng, 0184, South Africa
FCRN Clinical Trial Centre
Vereeniging, Gauteng, 1935, South Africa
Precise Clinical Solutions
Chatsworth, KwaZulu-Natal, 4092, South Africa
Private Practice - Dr. Peter Sebastian
Chatsworth, KwaZulu-Natal, 4092, South Africa
Synapta Clinical Research Centre
Durban, KwaZulu-Natal, 4001, South Africa
MERCLINCO Middleburg
Middelburg, Mpumalanga, 1050, South Africa
Aurum Institute - Rustenburg
Rustenburg, North West, 0299, South Africa
TREAD Research (Pty)Ltd
Cape Town, Western Cape, 7500, South Africa
TASK Applied Science
Cape Town, Western Cape, 7530, South Africa
Tiervlei Trial Centre
Cape Town, Western Cape, 7530, South Africa
TREAD Research
Cape Town, Western Cape, 7530, South Africa
Umzimkhulu Research Centre
uMzimkhulu, 3297, South Africa
Related Publications (1)
Fitz-Patrick D, McVinnie DS, Jackson LA, Crowther G, Geevarughese A, Cannon KD, Garcia LM, Pineiro Puebla Y, Yi Z, Cunliffe L, Maniar A, Zareba AM, Ianos CA, Gomme E, Koury K, Suphaphiphat Allen P, Anderson AS, Gurtman A, Lindert K; Pfizer C4781004 Trial Investigators. Efficacy, Immunogenicity, and Safety of Modified mRNA Influenza Vaccine. N Engl J Med. 2025 Nov 20;393(20):2001-2011. doi: 10.1056/NEJMoa2416779.
PMID: 41259756DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2022
First Posted
September 14, 2022
Study Start
September 12, 2022
Primary Completion
March 12, 2024
Study Completion
March 12, 2024
Last Updated
May 8, 2025
Results First Posted
May 8, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will 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.