A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older

April 18, 2025 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Influenza, Human

Intervention / Treatment

Detailed Description

This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a quadrivalent influenza modRNA vaccine (qIRV) encoding HA of 4 seasonally recommended strains (2 A strains and 2 B strains) compared to licensed quadrivalent influenza vaccine (QIV) in healthy adults 18 years of age and older.

Participants may be enrolled in either the reactogenicity subset, immunogenicity subset, or both/neither subset(s). Efficacy will be assessed in this study through surveillance for influenza-like illness.

Study Type

Interventional

Enrollment (Actual)

45789

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1426
    - Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
- Santa FE
  - Rosario, Santa FE, Argentina, S2000DEJ
    - Fundacion Estudios Clinicos
- Tucumán
  - San Miguel de Tucuman, Tucumán, Argentina, 4000
    - Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
Chile
- Región Metropolitana DE Santiago
  - Santiago, Región Metropolitana DE Santiago, Chile, 7500587
    - Enroll Spa
  - Santiago, Región Metropolitana DE Santiago, Chile, 7580206
    - Centro Skin Med Limitada
  - Santiago, Región Metropolitana DE Santiago, Chile, 8330336
    - CECIM
New Zealand
- - Auckland, New Zealand, 1010
    - Optimal Clinical Trials
  - Auckland, New Zealand, 0600
    - Southern Clinical Trials Totara
  - Auckland, New Zealand, 0632
    - Optimal Clinical Trials North
  - Nelson, New Zealand, 7011
    - Southern Clinical Trials Tasman
  - Wellington, New Zealand, 6021
    - P3 Research - Wellington
- BAY OF Plenty
  - Rotorua, BAY OF Plenty, New Zealand, 3010
    - Pacific Clinical Research Network - Rotorua
  - Tauranga, BAY OF Plenty, New Zealand, 3110
    - P3 Research - Tauranga
- Canterbury
  - Christchurch, Canterbury, New Zealand, 8013
    - Pacific Clinical Research Network - Forte
- Hawke's BAY
  - Hastings, Hawke's BAY, New Zealand, 4122
    - P3 Research - Hawke's Bay
- Waikato
  - Hamilton, Waikato, New Zealand, 3200
    - Lakeland Clinical Trials Waikato
- Wellington
  - Upper Hutt, Wellington, New Zealand, 5018
    - Lakeland Clinical Trials Wellington
Philippines
- - Dasmarinas, Philippines, 4114
    - De La Salle Medical and Health Sciences Institute
  - Dasmarinas City, Philippines
    - De La Salle Health Sciences Institute
  - Iloilo, Philippines, 5000
    - Iloilo Doctors' Hospital
  - Iloilo City, Philippines, 5000
    - St. Paul's Hospital of Iloilo, Inc.
  - Manila, Philippines, 1000
    - Philippine General Hospital
- Iloilo
  - Iloilo City, Iloilo, Philippines, 5000
    - West Visayas State University Medical Center
- Metro Manila
  - Mandaluyong, Metro Manila, Philippines, 1552
    - Health Cube Medical Clinics
- National Capital Region
  - Makati, National Capital Region, Philippines, 1230
    - Tropical Disease Foundation
  - Manila, National Capital Region, Philippines, 1012
    - Mary Johnston Hospital
  - Quezon City, National Capital Region, Philippines, 1100
    - Lung Center of the Philippines
  - Quezon City, National Capital Region, Philippines, 1118
    - Far Eastern University Nicanor Reyes Medical Foundation
- Palawan
  - Puerto Princesa, Palawan, Philippines, 5300
    - Adventist Hospital Palawan
South Africa
- - uMzimkhulu, South Africa, 3297
    - Umzimkhulu Research Centre
- Eastern CAPE
  - East London, Eastern CAPE, South Africa, 5241
    - Synergy Biomed Research Institute
  - Port Elizabeth, Eastern CAPE, South Africa, 6001
    - Phoenix Pharma
- FREE State
  - Bloemfontein, FREE State, South Africa, 9301
    - Josha Research
  - Bloemfontein, FREE State, South Africa, 9301
    - Iatros International
- Gauteng
  - Benoni, Gauteng, South Africa, 1500
    - Worthwhile Clinical Trials
  - Boksburg, Gauteng, South Africa, 1459
    - REIMED Reiger Park
  - Johannesburg, Gauteng, South Africa, 1818
    - Soweto Clinical Trials Centre
  - Kempton Park, Gauteng, South Africa, 1619
    - Clinresco Centres
  - Krugersdorp, Gauteng, South Africa, 1739
    - Ubuntu Clinical Research - Krugersdorp
  - Lenasia, Gauteng, South Africa, 1827
    - Ubuntu Clinical Research - Lenasia
  - Moloto, Gauteng, South Africa, 1022
    - Zinakekele Medicall Centre
  - Pretoria, Gauteng, South Africa, 0184
    - Botho ke Bontle Health Services
  - Pretoria, Gauteng, South Africa, 0002
    - Emmed Research
  - Pretoria, Gauteng, South Africa, 0157
    - Global Clinical Trials
  - Pretoria West, Gauteng, South Africa, 0183
    - Jongaie Research
  - Soweto, Gauteng, South Africa, 2013
    - Wits Clinical Research
  - Tshwane, Gauteng, South Africa, 0152
    - Setshaba Research Centre
  - Val De Grace, Gauteng, South Africa, 0184
    - Synexus Watermeyer Clinical Research Centre
  - Vereeniging, Gauteng, South Africa, 1935
    - FCRN Clinical Trial Centre
- Kwazulu-natal
  - Chatsworth, Kwazulu-natal, South Africa, 4092
    - Precise Clinical Solutions
  - Chatsworth, Kwazulu-natal, South Africa, 4092
    - Private Practice - Dr. Peter Sebastian
  - Durban, Kwazulu-natal, South Africa, 4001
    - Synapta Clinical Research Centre
- Mpumalanga
  - Middelburg, Mpumalanga, South Africa, 1050
    - MERCLINCO Middleburg
- North-west
  - Rustenburg, North-west, South Africa, 0299
    - Aurum Institute - Rustenburg
- Western CAPE
  - Cape Town, Western CAPE, South Africa, 7530
    - Tiervlei Trial Centre
  - Cape Town, Western CAPE, South Africa, 7500
    - Tread Research (Pty)Ltd
  - Cape Town, Western CAPE, South Africa, 7530
    - TASK Applied Science
  - Cape Town, Western CAPE, South Africa, 7530
    - TREAD Research
United States
- Alabama
  - Athens, Alabama, United States, 35611
    - North Alabama Research Center
  - Birmingham, Alabama, United States, 35205
    - St. Vincent's Birmingham Hospital
  - Birmingham, Alabama, United States, 35226
    - Ross Bridge Medical Practice, LLC-CCT Research
  - Birmingham, Alabama, United States, 35216
    - Accel Research Sites Network - Birmingham Clinical Research Unit
  - Dothan, Alabama, United States, 36305
    - SEC Clinical Research
  - Guntersville, Alabama, United States, 35976
    - Lakeview Clinical Research
  - Huntsville, Alabama, United States, 35801
    - Medical Affiliated Research Center
- Arizona
  - Glendale, Arizona, United States, 85308
    - Lenzmeier Family Medicine/CCT Research
  - Mesa, Arizona, United States, 85206
    - Aventiv Research
  - Mesa, Arizona, United States, 85213
    - Desert Clinical Research/ CCT Research
  - Phoenix, Arizona, United States, 85018
    - HOPE Research Institute
  - Phoenix, Arizona, United States, 85018
    - The Pain Center of Arizona
  - Phoenix, Arizona, United States, 85023
    - HOPE Research Institute
  - Phoenix, Arizona, United States, 85023
    - HOPE Research Institute - Phoenix
  - Phoenix, Arizona, United States, 85044
    - Foothills Research Center/ CCT Research
  - Surprise, Arizona, United States, 85378
    - Epic Medical Research - Surprise
  - Tempe, Arizona, United States, 85283
    - Fiel Family and Sports Medicine, PC/CCT Research
  - Tempe, Arizona, United States, 85284
    - HOPE Research Institute
  - Tucson, Arizona, United States, 85704
    - Noble Clinical Research
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - Baptist Health Center for Clinical Research
  - Little Rock, Arkansas, United States, 72212
    - Applied Research Center of Arkansas
- California
  - Anaheim, California, United States, 92801
    - Anaheim Clinical Trials
  - Banning, California, United States, 92220
    - Velocity Clinical Research, San Bernardino
  - Colton, California, United States, 92324
    - Benchmark Research
  - Fullerton, California, United States, 92835
    - Ascada Health PC dba Ascada Research
  - Huntington Beach, California, United States, 92647
    - Marvel Clinical Research
  - Huntington Park, California, United States, 90255
    - Velocity Clinical Research, Huntington Park
  - La Mesa, California, United States, 91942
    - Velocity Clinical Research, San Diego
  - Lake Forest, California, United States, 92630
    - Orange County Research Center
  - Long Beach, California, United States, 90815
    - ARK Clinical Research
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente
  - Los Angeles, California, United States, 90057
    - Velocity Clinical Research, Westlake
  - North Hollywood, California, United States, 91606
    - Velocity Clinical Research, North Hollywood
  - Paramount, California, United States, 90723
    - Center for Clinical Trials, LLC
  - Pomona, California, United States, 91767
    - Empire Clinical Research
  - Redding, California, United States, 96001
    - Paradigm Clinical Research Centers, Inc
  - Rolling Hills Estates, California, United States, 90274
    - Peninsula Research Associates
  - Sacramento, California, United States, 95864
    - Benchmark Research
  - San Diego, California, United States, 92123
    - California Research Foundation
  - San Diego, California, United States, 92103
    - Artemis Institute for Clinical Research
  - San Diego, California, United States, 92120
    - Wr-McCr, Llc
  - Spring Valley, California, United States, 91978
    - Encompass Clinical Research
  - Toluca Lake, California, United States, 91602
    - Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
  - Torrance, California, United States, 90504
    - Collaborative Neuroscience Research, LLC
  - Tustin, California, United States, 92780
    - Ark Clinical Research - Tustin
  - Walnut Creek, California, United States, 94598
    - Diablo Clinical Research, Inc.
- Colorado
  - Aurora, Colorado, United States, 80012
    - Lynn Institute of Denver
  - Fort Collins, Colorado, United States, 80525
    - Tekton Research, LLC.
  - Longmont, Colorado, United States, 80501
    - Tekton Research, LLC.
  - Wheat Ridge, Colorado, United States, 80033
    - Paradigm Clinical Research Centers, Inc
- Connecticut
  - Bridgeport, Connecticut, United States, 06606
    - New England Research Associates, LLC
  - Milford, Connecticut, United States, 06460
    - Clinical Research Consulting
  - New Haven, Connecticut, United States, 06511
    - New Haven Clinical Research Unit
  - New Haven, Connecticut, United States, 06519
    - Yale University School of Medicine
  - New Haven, Connecticut, United States, 06519
    - Yale Cardiology
  - Stamford, Connecticut, United States, 06905
    - Stamford Therapeutics Consortium
- District of Columbia
  - Washington, District of Columbia, United States, 20017
    - Washington Health Institute
- Florida
  - Atlantis, Florida, United States, 33462
    - JEM Research Institute
  - Clearwater, Florida, United States, 33761
    - Tampa Bay Medical Research
  - Coral Gables, Florida, United States, 33134
    - Alliance for Multispecialty Research, LLC
  - Doral, Florida, United States, 33166
    - Universal Axon Clinical Research, LLC
  - Fleming Island, Florida, United States, 32003
    - Fleming Island Center For Clinical Research
  - Fort Lauderdale, Florida, United States, 33308
    - Proactive Clinical Research,LLC
  - Fort Myers, Florida, United States, 33912
    - Alliance for Multispecialty Research, LLC
  - Fort Myers, Florida, United States, 33912
    - Robert B. Pritt, DO
  - Hialeah, Florida, United States, 33016
    - Best Quality Research,Inc.
  - Jacksonville, Florida, United States, 32216
    - Jacksonville Center for Clinical Research
  - Jacksonville, Florida, United States, 32256
    - Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
  - Jupiter, Florida, United States, 33458
    - Health Awareness
  - Lake City, Florida, United States, 32055
    - Wr-Msra.Llc
  - Lake Worth, Florida, United States, 33462
    - JEM Research Institute
  - Lakeland, Florida, United States, 33803
    - Accel Research Sites Network - Lakeland Clinical Research Unit
  - Largo, Florida, United States, 33777
    - Accel Research Sites - St. Petersburg Clinical Research Unit
  - Maitland, Florida, United States, 32751
    - Accel Research Sites Network - Maitland Clinical Research Unit
  - Miami, Florida, United States, 33176
    - Miami Dade Medical Research Institute, LLC
  - Miami, Florida, United States, 33176
    - Entrust Clinical Research
  - Miami, Florida, United States, 33156
    - Gerardo Polanco, MD
  - Miami, Florida, United States, 33130
    - Care Research - West Flagler Street
  - Miami Lakes, Florida, United States, 33014
    - Palm Springs Community Health Center
  - Orlando, Florida, United States, 32801
    - Clinical Neuroscience Solutions, Inc.
  - Orlando, Florida, United States, 32819
    - Headlands Research Orlando
  - Palmetto Bay, Florida, United States, 33157
    - Innovation Medical Research Center
  - Pembroke Pines, Florida, United States, 33029
    - DBC Research USA
  - Port Orange, Florida, United States, 32127
    - United Medical Research
  - Tampa, Florida, United States, 33603
    - Genesis Clinical Research, LLC
  - Tampa, Florida, United States, 33614
    - Angels Clinical Research Institute
  - Winter Park, Florida, United States, 32789
    - Clinical Site Partners, LLC dba Flourish Research
- Georgia
  - Columbus, Georgia, United States, 31904
    - Centricity Research Columbus Georgia Multispecialty
  - Rincon, Georgia, United States, 31326
    - IACT Health
  - Rincon, Georgia, United States, 31406
    - Centricity Research Rincon Pulmonology
  - Sandy Springs, Georgia, United States, 30328
    - WR-Mount Vernon Clinical Research, LLC
  - Sandy Springs, Georgia, United States, 30328
    - Agile Clinical Research Trials, LLC
  - Savannah, Georgia, United States, 31406
    - Javara - Privia Medical Group Georgia - Savannah
  - Savannah, Georgia, United States, 31405
    - CenExel iResearch, LLC
  - Savannah, Georgia, United States, 31406
    - Velocity Clinical Research, Savannah
  - Stockbridge, Georgia, United States, 30281
    - Clinical Research Atlanta
  - Union City, Georgia, United States, 30291
    - Rophe Adult and Pediatric Medicine/SKYCRNG
- Hawaii
  - Honolulu, Hawaii, United States, 96814
    - East-West Medical Research Institute
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Clinical Research Prime
  - Meridian, Idaho, United States, 83646
    - Solaris Clinical Research
- Illinois
  - Morton, Illinois, United States, 61550
    - Koch Family Medicine
  - Oak Lawn, Illinois, United States, 60453
    - Accellacare - DuPage
- Indiana
  - Evansville, Indiana, United States, 47712
    - MediSphere Medical Research Center - Evansville - West Franklin Street
  - Evansville, Indiana, United States, 47714
    - MediSphere Medical Research Center - EAST
  - Valparaiso, Indiana, United States, 46383
    - Velocity Clinical Research, Valparaiso
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa
  - Sioux City, Iowa, United States, 51106
    - Velocity Clinical Research, Sioux City
- Kansas
  - Newton, Kansas, United States, 67114
    - Alliance for Multispecialty Research, LLC
  - Wichita, Kansas, United States, 67207
    - Alliance for Multispecialty Research, LLC
  - Wichita, Kansas, United States, 67205
    - Alliance for Multispecialty Research, LLC
- Kentucky
  - Lexington, Kentucky, United States, 40509
    - Alliance for Multispecialty Research, LLC
  - Versailles, Kentucky, United States, 40383
    - Versailles Family Medicine / CCT Research
- Louisiana
  - Lafayette, Louisiana, United States, 70508
    - MedPharmics, LLC
  - New Orleans, Louisiana, United States, 70119
    - Alliance for Multispecialty Research, LLC
  - New Orleans, Louisiana, United States, 70115
    - DelRicht Research
  - Shreveport, Louisiana, United States, 71101
    - Louisiana State University Health Sciences Shreveport
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Pharmaron
  - Rockville, Maryland, United States, 20850
    - Advanced Primary and Geriatric Care - CCT Research
  - Silver Spring, Maryland, United States, 20904
    - Jadestone Clinical Research
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Brigham and Women's Hospital
  - Boston, Massachusetts, United States, 02118
    - Boston Medical Center
  - Methuen, Massachusetts, United States, 01844
    - ActivMed Practices and Research
  - Worcester, Massachusetts, United States, 01655
    - University of Massachusetts Chan Medical School
- Michigan
  - Detroit, Michigan, United States, 48202
    - Henry Ford Hospital
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Ascension St. John Hospital
  - Sterling Heights, Michigan, United States, 48312
    - Revival Research Institute, LLC
  - Troy, Michigan, United States, 48098
    - Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
  - Troy, Michigan, United States, 48085
    - Oakland Medical Research
- Missouri
  - Chesterfield, Missouri, United States, 63005
    - Clinical Research Professionals
  - Saint Louis, Missouri, United States, 63141
    - Sundance Clinical Research
  - Saint Louis, Missouri, United States, 63104
    - Saint Louis University Center for Vaccine Development
  - Springfield, Missouri, United States, 65802
    - Bio-Kinetic Clinical Applications, LLD dba QPS-MO
  - Springfield, Missouri, United States, 65807
    - QPS Bio-Kinetic Clinical Applications (Patient Screening Only)
- Montana
  - Bozeman, Montana, United States, 59715
    - Bozeman Health Deaconess Hospital
- Nebraska
  - Fremont, Nebraska, United States, 68025
    - Methodist Physicians Clinic/CCT Research
  - Grand Island, Nebraska, United States, 68803
    - Velocity Clinical Research, Grand Island
  - Lincoln, Nebraska, United States, 68516
    - Be Well Clinical Studies
  - Norfolk, Nebraska, United States, 68701
    - Velocity Clinical Research, Norfolk
  - Omaha, Nebraska, United States, 68114
    - Quality Clinical Research
  - Omaha, Nebraska, United States, 68134
    - Velocity Clinical Research, Omaha
  - Papillion, Nebraska, United States, 68046
    - Papillion Research Center/CCT Research
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Excel Clinical Research, LLC
  - Las Vegas, Nevada, United States, 89119
    - Santa Rosa Medical Centers of Nevada / CCT Research
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - ActivMed Practices & Research, LLC.
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center
  - Hackensack, New Jersey, United States, 07601
    - David Jurist Research Building
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center Medical Plaza
  - Somers Point, New Jersey, United States, 08244
    - South Jersey Infectious Disease
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - Albuquerque Clinical Trials, Inc.
  - Albuquerque, New Mexico, United States, 87107
    - Velocity Clinical Research, Albuquerque
- New York
  - Horseheads, New York, United States, 14845
    - Smith Allergy & Asthma Specialists
  - New York, New York, United States, 10016
    - NYU Langone Health
  - Rochester, New York, United States, 14609
    - Rochester Clinical Research, LLC
  - Vestal, New York, United States, 13850
    - Velocity Clinical Research, Vestal
- North Carolina
  - Cary, North Carolina, United States, 27518
    - Accellacare - Cary
  - Charlotte, North Carolina, United States, 28211
    - Accellacare - Charlotte
  - Fayetteville, North Carolina, United States, 28303
    - Carolina Institute for Clinical Research
  - Greensboro, North Carolina, United States, 27408
    - PharmQuest Life Sciences, LLC
  - Hickory, North Carolina, United States, 28601
    - Accellacare - Hickory
  - Monroe, North Carolina, United States, 28112
    - Monroe Biomedical Research
  - Raleigh, North Carolina, United States, 27612
    - M3 Wake Research, Inc.
  - Raleigh, North Carolina, United States, 27609
    - Accellacare - Raleigh
  - Rocky Mount, North Carolina, United States, 27804
    - Accellacare - Rocky Mount
  - Salisbury, North Carolina, United States, 28144
    - Accellacare - Salisbury
  - Wilmington, North Carolina, United States, 28401
    - Accellacare - Wilmington
  - Wilmington, North Carolina, United States, 28403
    - Trial Management Associates - Wilmington - Floral Parkway
  - Winston-Salem, North Carolina, United States, 27103
    - Accellacare - Winston-Salem
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Plains Medical Clinic, LLC
  - Fargo, North Dakota, United States, 58104
    - Plains Clinical Research Center
- Ohio
  - Cincinnati, Ohio, United States, 45229
    - Cincinnati Children's Hospital Medical Center
  - Cincinnati, Ohio, United States, 45212
    - CTI Clinical Research Center
  - Cincinnati, Ohio, United States, 45219
    - Meridian Clinical Research, LLC
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Cleveland Medical Center
  - Cleveland, Ohio, United States, 44122
    - Velocity Clinical Research, Cleveland
  - Cleveland, Ohio, United States, 44121
    - Senders Pediatrics
  - Columbus, Ohio, United States, 43213
    - Centricity Research Columbus Ohio Multispecialty
  - Dayton, Ohio, United States, 45409
    - Dayton Clinical Research
  - Dayton, Ohio, United States, 45429
    - PriMed Clinical Research
  - Dayton, Ohio, United States, 45424
    - WellNow Urgent Care & Research
- Oklahoma
  - Edmond, Oklahoma, United States, 73013
    - Tekton Research, LLC.
  - Moore, Oklahoma, United States, 73160
    - Tekton Research, LLC.
  - Norman, Oklahoma, United States, 73072
    - Lynn Institute of Norman
  - Oklahoma City, Oklahoma, United States, 73112
    - Lynn Health Science Institute
  - Yukon, Oklahoma, United States, 73099
    - Tekton Research, LLC.
- Oregon
  - Medford, Oregon, United States, 97504
    - Velocity Clinical Research, Medford
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Northwest Center for Health Research
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18102
    - Lehigh Valley Health Network
  - Camp Hill, Pennsylvania, United States, 17011
    - Capital Area Research, LLC
  - Erie, Pennsylvania, United States, 16508
    - Central Erie Primary Care
- Rhode Island
  - East Greenwich, Rhode Island, United States, 02818
    - Velocity Clinical Research, Providence
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Velocity Clinical Research, Anderson
  - Charleston, South Carolina, United States, 29412
    - Pharmacorp Clinical Trials
  - Columbia, South Carolina, United States, 29204
    - Velocity Clinical Research, Columbia
  - Gaffney, South Carolina, United States, 29340
    - Velocity Clinical Research, Gaffney
  - Greenville, South Carolina, United States, 29607
    - Tribe Clinical Research, LLC
  - Little River, South Carolina, United States, 29566
    - Main Street Physician's Care
  - Moncks Corner, South Carolina, United States, 29461
    - Clinical Trials of South Carolina
  - Myrtle Beach, South Carolina, United States, 29572
    - Trial Management Associates
  - North Charleston, South Carolina, United States, 29405
    - Coastal Carolina Research Center
  - Spartanburg, South Carolina, United States, 29303
    - Velocity Clinical Research, Spartanburg
  - Union, South Carolina, United States, 29379
    - Velocity Clinical Research, Union
- Tennessee
  - Bristol, Tennessee, United States, 37620
    - Internal Medicine and Pediatric Associates of Bristol
  - Chattanooga, Tennessee, United States, 37421
    - WR-Clinsearch, LLC
  - Kingsport, Tennessee, United States, 37660
    - Holston Medical Group
  - Knoxville, Tennessee, United States, 37909
    - New Phase Research and Development
  - Knoxville, Tennessee, United States, 37909
    - Alliance for Multispecialty Research, LLC
  - Knoxville, Tennessee, United States, 37912
    - Accellacare US Inc., d/b/a Accellacare of Knoxville
  - Knoxville, Tennessee, United States, 37938
    - Accellacare US Inc., d/b/a Accellacare of Knoxville
  - Memphis, Tennessee, United States, 38119
    - Clinical Neuroscience Solutions Inc.
- Texas
  - Austin, Texas, United States, 78705
    - Benchmark Research
  - Austin, Texas, United States, 78759
    - Orion Clinical Research
  - Austin, Texas, United States, 78704
    - Elligo Clinical Research Center
  - Austin, Texas, United States, 78745
    - Tekton Research, LLC.
  - Austin, Texas, United States, 78759
    - Velocity Clinical Research, Austin
  - Brownsville, Texas, United States, 78526
    - Headlands Research - Brownsville
  - Dallas, Texas, United States, 75246
    - North Texas Infectious Diseases Consultants, P.A
  - Dallas, Texas, United States, 75234
    - DFW Clinical Research
  - Dallas, Texas, United States, 75224
    - WR-Global Medical Research, LLC
  - DeSoto, Texas, United States, 75115
    - Epic Medical Research - DeSoto
  - Edinburg, Texas, United States, 78539
    - Proactive Clinical Research, LLC
  - Fort Worth, Texas, United States, 76135
    - Benchmark Research
  - Fort Worth, Texas, United States, 76135
    - Texas Health Family Care
  - Friendswood, Texas, United States, 77546
    - Allure Health
  - Houston, Texas, United States, 77040
    - Juno Research
  - Houston, Texas, United States, 77054
    - Prolato Clinical Research Center
  - Houston, Texas, United States, 77008
    - Trio Clinical Trials
  - Houston, Texas, United States, 77087
    - Santa Clara Family Clinic
  - Houston, Texas, United States, 77081
    - DM Clinical Research - Bellaire
  - Humble, Texas, United States, 77338
    - Dynamed Clinical Research, LP d/b/a DM Clinical Research
  - Laredo, Texas, United States, 78041
    - Andres Garcia Zuniga, M.D., P.A.
  - Mesquite, Texas, United States, 75149
    - SMS Clinical Research
  - Plano, Texas, United States, 75093
    - AIM Trials, LLC
  - San Antonio, Texas, United States, 78229
    - Clinical Trials of Texas, LLC
  - San Antonio, Texas, United States, 78229
    - IMA Clinical Research San Antonio
  - San Antonio, Texas, United States, 78229
    - Tekton Research, LLC.
  - Stephenville, Texas, United States, 76401
    - Javara - Privia Medical Group North Texas - Stephenville
  - Sugar Land, Texas, United States, 77479
    - Sugar Lakes Family Practice, PA
  - Tomball, Texas, United States, 77375
    - Northwest Houston Heart Center
  - Tomball, Texas, United States, 77375
    - DM Clinical Research, Martin Diagnostic Clinic
  - Victoria, Texas, United States, 77901
    - Crossroads Clinical Research
- Utah
  - Bountiful, Utah, United States, 84010
    - Cope Family Medicine / CCT Research
  - Ogden, Utah, United States, 84405
    - South Ogden Family Medicine/ CCT Research
  - Salt Lake City, Utah, United States, 84109
    - J. Lewis Research, Inc. / Foothill Family Clinic
  - Salt Lake City, Utah, United States, 84121
    - J. Lewis Research, Inc. / Foothill Family Clinic South
  - Salt Lake City, Utah, United States, 84117
    - Olympus Family Medicine/CCT Research
  - South Jordan, Utah, United States, 84095
    - J. Lewis Research, Inc. / Jordan River Family Medicine
  - Springville, Utah, United States, 84663
    - Springville Dermatology - Springville/CCT Research
  - West Jordan, Utah, United States, 84088
    - Velocity Clinical Research, Salt Lake City
- Virginia
  - Annandale, Virginia, United States, 22003
    - Clinical Alliance for Research and Education - Infectious Diseases (CARE-ID), LLC
  - Charlottesville, Virginia, United States, 22911
    - Charlottesville Medical Research
  - Midlothian, Virginia, United States, 23114
    - Virginia Research Center
  - Newport News, Virginia, United States, 23606
    - Health Research of Hampton Roads, Inc.
  - Norfolk, Virginia, United States, 23502
    - Alliance for Multispecialty Research, LLC
  - Portsmouth, Virginia, United States, 23703
    - Meridian Clinical Research LLC
  - Richmond, Virginia, United States, 23226
    - Clinical Research Partners, LLC
  - Suffolk, Virginia, United States, 23435
    - Centricity Research Suffolk Primary Care
- Washington
  - Kirkland, Washington, United States, 98034
    - EvergreenHealth
  - Kirkland, Washington, United States, 98034
    - EvergreenHealth Medical Center
  - Renton, Washington, United States, 98057
    - Rainier Clinical Research Center
  - Seattle, Washington, United States, 98101
    - Kaiser Permanente Washington Health Research Institute
  - Seattle, Washington, United States, 98105
    - Seattle Clinical Research Center
  - Seattle, Washington, United States, 98101
    - Kaiser Permanente Washington Health Research Institute (KPWHRI)
- Wisconsin
  - Wauwatosa, Wisconsin, United States, 53226
    - Allegiance Research Specialists, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.
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.
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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadrivalent influenza modRNA vaccine, 18 through 64 years of age Quadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age	Biological: Quadrivalent influenza modRNA vaccine Quadrivalent influenza modRNA vaccine (single dose)
Active Comparator: Quadrivalent influenza vaccine, 18 through 64 years of age Licensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age	Biological: Quadrivalent influenza vaccine Licensed quadrivalent influenza vaccine (single dose)
Experimental: Quadrivalent influenza modRNA vaccine, ≥65 years of age Quadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age	Biological: Quadrivalent influenza modRNA vaccine Quadrivalent influenza modRNA vaccine (single dose)
Active Comparator: Quadrivalent influenza vaccine, ≥65 years of age Licensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age	Biological: Quadrivalent influenza vaccine Licensed quadrivalent influenza vaccine (single dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Time Frame: Day 15 to surveillance cut-off (approximately 6 months)	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 Time Frame: Day 15 up to primary surveillance cut-off (approximately 1 year)	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 Time Frame: From Day 1 to Day 7 after study vaccination	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 Time Frame: From Day 1 to Day 7 after study vaccination	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 Time Frame: From Day 1 to Day 7 after study vaccination	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 Time Frame: From Day 1 to Day 7 after study vaccination	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 Time Frame: From study vaccination on Day 1 through 4 weeks after study vaccination	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 Time Frame: From study vaccination on Day 1 through 4 weeks after study vaccination	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 Time Frame: From study vaccination on Day 1 through 4 weeks after study vaccination	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 Time Frame: From Day 1 up to 6 months after vaccination	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 Time Frame: From Day 1 up to 6 months after vaccination	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 Time Frame: From Day 1 up to 6 months after vaccination	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 Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Actual)

March 12, 2024

Study Completion (Actual)

March 12, 2024

Study Registration Dates

First Submitted

September 8, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 14, 2022

Study Record Updates

Last Update Posted (Actual)

May 8, 2025

Last Update Submitted That Met QC Criteria

April 18, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

C4781004
NCT05540522 (Registry Identifier: ClinicalTrials.gov)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Influenza, Human

Clinical Trials on Quadrivalent influenza modRNA vaccine

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