AzTrials
AzTrials

Influenza, HumanPhase 3NCT05540522

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

A Phase 3 study testing Quadrivalent influenza modRNA vaccine and Quadrivalent influenza vaccine in people with Influenza, Human, run by Pfizer at 321 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza, Human
What is being tested?
Quadrivalent influenza modRNA vaccine and Quadrivalent influenza vaccine
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45,789 participants
Where
321 sitesin 6 countries
Study dates
12 Sep 2022to 12 Mar 2024
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

321 sites in 6 countries.

321 sites in 6 countries

United States263 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • Velocity Clinical Research, Albuquerque

    Albuquerque, New Mexico, 87107

  • Lehigh Valley Health Network

    Allentown, Pennsylvania, 18102

  • Anaheim Clinical Trials

    Anaheim, California, 92801

  • Velocity Clinical Research, Anderson

    Anderson, South Carolina, 29621

  • Clinical Alliance for Research and Education - Infectious Diseases (CARE-ID), LLC

    Annandale, Virginia, 22003

  • North Alabama Research Center

    Athens, Alabama, 35611

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Elligo Clinical Research Center

    Austin, Texas, 78704

  • Benchmark Research

    Austin, Texas, 78705

  • Tekton Research, LLC.

    Austin, Texas, 78745

  • Orion Clinical Research

    Austin, Texas, 78759

  • Velocity Clinical Research, Austin

    Austin, Texas, 78759

  • Pharmaron

    Baltimore, Maryland, 21201

  • Velocity Clinical Research, San Bernardino

    Banning, California, 92220

  • St. Vincent's Birmingham Hospital

    Birmingham, Alabama, 35205

  • Accel Research Sites Network - Birmingham Clinical Research Unit

    Birmingham, Alabama, 35216

  • Ross Bridge Medical Practice, LLC-CCT Research

    Birmingham, Alabama, 35226

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Cope Family Medicine / CCT Research

    Bountiful, Utah, 84010

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • New England Research Associates, LLC

    Bridgeport, Connecticut, 06606

  • Internal Medicine and Pediatric Associates of Bristol

    Bristol, Tennessee, 37620

  • Headlands Research - Brownsville

    Brownsville, Texas, 78526

  • Capital Area Research, LLC

    Camp Hill, Pennsylvania, 17011

  • Accellacare - Cary

    Cary, North Carolina, 27518

  • Pharmacorp Clinical Trials

    Charleston, South Carolina, 29412

  • Accellacare - Charlotte

    Charlotte, North Carolina, 28211

  • Charlottesville Medical Research

    Charlottesville, Virginia, 22911

  • WR-Clinsearch, LLC

    Chattanooga, Tennessee, 37421

  • Clinical Research Professionals

    Chesterfield, Missouri, 63005

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • Meridian Clinical Research, LLC

    Cincinnati, Ohio, 45219

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio, 45229

  • Tampa Bay Medical Research

    Clearwater, Florida, 33761

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Senders Pediatrics

    Cleveland, Ohio, 44121

  • Velocity Clinical Research, Cleveland

    Cleveland, Ohio, 44122

  • Benchmark Research

    Colton, California, 92324

  • Velocity Clinical Research, Columbia

    Columbia, South Carolina, 29204

  • Centricity Research Columbus Georgia Multispecialty

    Columbus, Georgia, 31904

  • Centricity Research Columbus Ohio Multispecialty

    Columbus, Ohio, 43213

  • Alliance for Multispecialty Research, LLC

    Coral Gables, Florida, 33134

  • WR-Global Medical Research, LLC

    Dallas, Texas, 75224

  • DFW Clinical Research

    Dallas, Texas, 75234

  • North Texas Infectious Diseases Consultants, P.A

    Dallas, Texas, 75246

  • Dayton Clinical Research

    Dayton, Ohio, 45409

  • WellNow Urgent Care & Research

    Dayton, Ohio, 45424

  • PriMED Clinical Research

    Dayton, Ohio, 45429

  • Epic Medical Research - DeSoto

    DeSoto, Texas, 75115

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Universal Axon Clinical Research, LLC

    Doral, Florida, 33166

  • SEC Clinical Research

    Dothan, Alabama, 36305

  • Velocity Clinical Research, Providence

    East Greenwich, Rhode Island, 02818

  • Proactive Clinical Research, LLC

    Edinburg, Texas, 78539

  • Tekton Research, LLC.

    Edmond, Oklahoma, 73013

  • Central Erie Primary Care

    Erie, Pennsylvania, 16508

  • MediSphere Medical Research Center - Evansville - West Franklin Street

    Evansville, Indiana, 47712

  • MediSphere Medical Research Center - EAST

    Evansville, Indiana, 47714

  • Plains Clinical Research Center

    Fargo, North Dakota, 58104

  • Plains Medical Clinic, LLC

    Fargo, North Dakota, 58104

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 28303

  • Fleming Island Center for Clinical Research

    Fleming Island, Florida, 32003

  • Tekton Research, LLC.

    Fort Collins, Colorado, 80525

  • Proactive Clinical Research,LLC

    Fort Lauderdale, Florida, 33308

  • Alliance for Multispecialty Research, LLC

    Fort Myers, Florida, 33912

  • Robert B. Pritt, DO

    Fort Myers, Florida, 33912

  • Benchmark Research

    Fort Worth, Texas, 76135

  • Texas Health Family Care

    Fort Worth, Texas, 76135

  • Methodist Physicians Clinic/CCT Research

    Fremont, Nebraska, 68025

  • Allure Health

    Friendswood, Texas, 77546

  • Ascada Health PC dba Ascada Research

    Fullerton, California, 92835

  • Velocity Clinical Research, Gaffney

    Gaffney, South Carolina, 29340

  • Lenzmeier Family Medicine/CCT Research

    Glendale, Arizona, 85308

  • Velocity Clinical Research, Grand Island

    Grand Island, Nebraska, 68803

  • PharmQuest Life Sciences, LLC

    Greensboro, North Carolina, 27408

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • Ascension St. John Hospital

    Grosse Pointe Woods, Michigan, 48236

  • Lakeview Clinical Research

    Guntersville, Alabama, 35976

  • David Jurist Research Building

    Hackensack, New Jersey, 07601

  • Hackensack University Medical Center Medical Plaza

    Hackensack, New Jersey, 07601

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Best Quality Research,Inc.

    Hialeah, Florida, 33016

  • Accellacare - Hickory

    Hickory, North Carolina, 28601

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814

  • Smith Allergy & Asthma Specialists

    Horseheads, New York, 14845

  • Trio Clinical Trials

    Houston, Texas, 77008

  • Juno Research

    Houston, Texas, 77040

  • Prolato Clinical Research Center

    Houston, Texas, 77054

  • DM Clinical Research - Bellaire

    Houston, Texas, 77081

  • Santa Clara Family Clinic

    Houston, Texas, 77087

  • Dynamed Clinical Research, LP d/b/a DM Clinical Research

    Humble, Texas, 77338

  • Marvel Clinical Research

    Huntington Beach, California, 92647

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

  • Medical Affiliated Research Center

    Huntsville, Alabama, 35801

  • Clinical Research Prime

    Idaho Falls, Idaho, 83404

  • University of Iowa

    Iowa City, Iowa, 52242

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256

  • Health Awareness

    Jupiter, Florida, 33458

  • Holston Medical Group

    Kingsport, Tennessee, 37660

  • EvergreenHealth Medical Center

    Kirkland, Washington, 98034

  • EvergreenHealth

    Kirkland, Washington, 98034

  • Alliance for Multispecialty Research, LLC

    Knoxville, Tennessee, 37909

  • New Phase Research and Development

    Knoxville, Tennessee, 37909

  • Accellacare US Inc., d/b/a Accellacare of Knoxville

    Knoxville, Tennessee, 37912

  • Accellacare US Inc., d/b/a Accellacare of Knoxville

    Knoxville, Tennessee, 37938

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942

  • MedPharmics, LLC

    Lafayette, Louisiana, 70508

  • Wr-Msra.Llc

    Lake City, Florida, 32055

  • Orange County Research Center

    Lake Forest, California, 92630

  • JEM Research Institute

    Lake Worth, Florida, 33462

  • Accel Research Sites Network - Lakeland Clinical Research Unit

    Lakeland, Florida, 33803

  • Andres Garcia Zuniga, M.D., P.A.

    Laredo, Texas, 78041

  • Accel Research Sites - St. Petersburg Clinical Research Unit

    Largo, Florida, 33777

  • Excel Clinical Research, LLC

    Las Vegas, Nevada, 89109

  • Santa Rosa Medical Centers of Nevada / CCT Research

    Las Vegas, Nevada, 89119

  • Alliance for Multispecialty Research, LLC

    Lexington, Kentucky, 40509

  • Be Well Clinical Studies

    Lincoln, Nebraska, 68516

  • Main Street Physician's Care

    Little River, South Carolina, 29566

  • Baptist Health Center For Clinical Research

    Little Rock, Arkansas, 72205

  • Applied Research Center of Arkansas

    Little Rock, Arkansas, 72212

  • Ark Clinical Research

    Long Beach, California, 90815

  • Tekton Research, LLC.

    Longmont, Colorado, 80501

  • Kaiser Permanente

    Los Angeles, California, 90027

  • Velocity Clinical Research, Westlake

    Los Angeles, California, 90057

  • Accel Research Sites Network - Maitland Clinical Research Unit

    Maitland, Florida, 32751

  • Velocity Clinical Research, Medford

    Medford, Oregon, 97504

  • Clinical Neuroscience Solutions Inc.

    Memphis, Tennessee, 38119

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Aventiv Research

    Mesa, Arizona, 85206

  • Desert Clinical Research/ CCT Research

    Mesa, Arizona, 85213

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • ActivMed Practices and Research

    Methuen, Massachusetts, 01844

  • Care Research - West Flagler Street

    Miami, Florida, 33130

  • Gerardo Polanco, MD

    Miami, Florida, 33156

  • Entrust Clinical Research

    Miami, Florida, 33176

  • Miami Dade Medical Research Institute, LLC

    Miami, Florida, 33176

  • Palm Springs Community Health Center

    Miami Lakes, Florida, 33014

  • Virginia Research Center

    Midlothian, Virginia, 23114

  • Clinical Research Consulting

    Milford, Connecticut, 06460

  • Clinical Trials of South Carolina

    Moncks Corner, South Carolina, 29461

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Tekton Research, LLC.

    Moore, Oklahoma, 73160

  • Koch Family Medicine

    Morton, Illinois, 61550

  • Trial Management Associates

    Myrtle Beach, South Carolina, 29572

  • New Haven Clinical Research Unit

    New Haven, Connecticut, 06511

  • Yale Cardiology

    New Haven, Connecticut, 06519

  • Yale University School of Medicine

    New Haven, Connecticut, 06519

  • DelRicht Research

    New Orleans, Louisiana, 70115

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana, 70119

  • NYU Langone Health

    New York, New York, 10016

  • Health Research of Hampton Roads, Inc.

    Newport News, Virginia, 23606

  • Alliance for Multispecialty Research, LLC

    Newton, Kansas, 67114

  • Velocity Clinical Research, Norfolk

    Norfolk, Nebraska, 68701

  • Alliance for Multispecialty Research, LLC

    Norfolk, Virginia, 23502

  • Lynn Institute of Norman

    Norman, Oklahoma, 73072

  • Coastal Carolina Research Center

    North Charleston, South Carolina, 29405

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91606

  • Accellacare - DuPage

    Oak Lawn, Illinois, 60453

  • South Ogden Family Medicine/ CCT Research

    Ogden, Utah, 84405

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Quality Clinical Research

    Omaha, Nebraska, 68114

  • Velocity Clinical Research, Omaha

    Omaha, Nebraska, 68134

  • Clinical Neuroscience Solutions, Inc.

    Orlando, Florida, 32801

  • Headlands Research Orlando

    Orlando, Florida, 32819

  • Innovation Medical Research Center

    Palmetto Bay, Florida, 33157

  • Papillion Research Center/CCT Research

    Papillion, Nebraska, 68046

  • Center for Clinical Trials, LLC

    Paramount, California, 90723

  • DBC Research USA

    Pembroke Pines, Florida, 33029

  • HOPE Research Institute

    Phoenix, Arizona, 85018

  • The Pain Center of Arizona

    Phoenix, Arizona, 85018

  • HOPE Research Institute - Phoenix

    Phoenix, Arizona, 85023

  • HOPE Research Institute

    Phoenix, Arizona, 85023

  • Foothills Research Center/ CCT Research

    Phoenix, Arizona, 85044

  • AIM Trials, LLC

    Plano, Texas, 75093

  • Empire Clinical Research

    Pomona, California, 91767

  • United Medical Research

    Port Orange, Florida, 32127

  • Kaiser Permanente Northwest Center for Health Research

    Portland, Oregon, 97227

  • ActivMed Practices & Research, LLC.

    Portsmouth, New Hampshire, 03801

  • Meridian Clinical Research LLC

    Portsmouth, Virginia, 23703

  • Accellacare - Raleigh

    Raleigh, North Carolina, 27609

  • M3 Wake Research, Inc.

    Raleigh, North Carolina, 27612

  • Paradigm Clinical Research Centers, Inc

    Redding, California, 96001

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Clinical Research Partners, LLC

    Richmond, Virginia, 23226

  • IACT Health

    Rincon, Georgia, 31326

  • Centricity Research Rincon Pulmonology

    Rincon, Georgia, 31406

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • Advanced Primary and Geriatric Care - CCT Research

    Rockville, Maryland, 20850

  • Accellacare - Rocky Mount

    Rocky Mount, North Carolina, 27804

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Benchmark Research

    Sacramento, California, 95864

  • Accellacare - Salisbury

    Salisbury, North Carolina, 28144

  • J. Lewis Research, Inc. / Foothill Family Clinic

    Salt Lake City, Utah, 84109

  • Olympus Family Medicine/CCT Research

    Salt Lake City, Utah, 84117

  • J. Lewis Research, Inc. / Foothill Family Clinic South

    Salt Lake City, Utah, 84121

  • Clinical Trials of Texas, LLC

    San Antonio, Texas, 78229

  • IMA Clinical Research San Antonio

    San Antonio, Texas, 78229

  • Tekton Research, LLC.

    San Antonio, Texas, 78229

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

  • Wr-McCr, Llc

    San Diego, California, 92120

  • California Research Foundation

    San Diego, California, 92123

  • AGILE Clinical Research Trials, LLC

    Sandy Springs, Georgia, 30328

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia, 30328

  • CenExel iResearch, LLC

    Savannah, Georgia, 31405

  • Javara - Privia Medical Group Georgia - Savannah

    Savannah, Georgia, 31406

  • Velocity Clinical Research, Savannah

    Savannah, Georgia, 31406

  • Kaiser Permanente Washington Health Research Institute (KPWHRI)

    Seattle, Washington, 98101

  • Kaiser Permanente Washington Health Research Institute

    Seattle, Washington, 98101

  • Seattle Clinical Research Center

    Seattle, Washington, 98105

  • Louisiana State University Health Sciences Shreveport

    Shreveport, Louisiana, 71101

  • Jadestone Clinical Research

    Silver Spring, Maryland, 20904

  • Velocity Clinical Research, Sioux City

    Sioux City, Iowa, 51106

  • South Jersey Infectious Disease

    Somers Point, New Jersey, 08244

  • J. Lewis Research, Inc. / Jordan River Family Medicine

    South Jordan, Utah, 84095

  • Velocity Clinical Research, Spartanburg

    Spartanburg, South Carolina, 29303

  • Encompass Clinical Research

    Spring Valley, California, 91978

  • Bio-Kinetic Clinical Applications, LLD dba QPS-MO

    Springfield, Missouri, 65802

  • QPS Bio-Kinetic Clinical Applications (Patient Screening Only)

    Springfield, Missouri, 65807

  • Springville Dermatology - Springville/CCT Research

    Springville, Utah, 84663

  • Saint Louis University Center for Vaccine Development

    St Louis, Missouri, 63104

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Javara - Privia Medical Group North Texas - Stephenville

    Stephenville, Texas, 76401

  • Revival Research Institute, LLC

    Sterling Heights, Michigan, 48312

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Centricity Research Suffolk Primary Care

    Suffolk, Virginia, 23435

  • Sugar Lakes Family Practice, PA

    Sugar Land, Texas, 77479

  • Epic Medical Research - Surprise

    Surprise, Arizona, 85378

  • Genesis Clinical Research, LLC

    Tampa, Florida, 33603

  • Angels Clinical Research Institute

    Tampa, Florida, 33614

  • Fiel Family and Sports Medicine, PC/CCT Research

    Tempe, Arizona, 85283

  • HOPE Research Institute

    Tempe, Arizona, 85284

  • Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.

    Toluca Lake, California, 91602

  • DM Clinical Research, Martin Diagnostic Clinic

    Tomball, Texas, 77375

  • Northwest Houston Heart Center

    Tomball, Texas, 77375

  • Collaborative Neuroscience Research, LLC

    Torrance, California, 90504

  • Oakland Medical Research

    Troy, Michigan, 48085

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

  • Noble Clinical Research

    Tucson, Arizona, 85704

  • Ark Clinical Research - Tustin

    Tustin, California, 92780

  • Velocity Clinical Research, Union

    Union, South Carolina, 29379

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291

  • Velocity Clinical Research, Valparaiso

    Valparaiso, Indiana, 46383

  • Versailles Family Medicine / CCT Research

    Versailles, Kentucky, 40383

  • Velocity Clinical Research, Vestal

    Vestal, New York, 13850

  • Crossroads Clinical Research

    Victoria, Texas, 77901

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Washington Health Institute

    Washington D.C., District of Columbia, 20017

  • Allegiance Research Specialists, LLC

    Wauwatosa, Wisconsin, 53226

  • Velocity Clinical Research, Salt Lake City

    West Jordan, Utah, 84088

  • Paradigm Clinical Research Centers, Inc

    Wheat Ridge, Colorado, 80033

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67205

  • Alliance for Multispecialty Research, LLC

    Wichita, Kansas, 67207

  • Accellacare - Wilmington

    Wilmington, North Carolina, 28401

  • Trial Management Associates - Wilmington - Floral Parkway

    Wilmington, North Carolina, 28403

  • Accellacare - Winston-Salem

    Winston-Salem, North Carolina, 27103

  • Clinical Site Partners, LLC dba Flourish Research

    Winter Park, Florida, 32789

  • University of Massachusetts Chan Medical School

    Worcester, Massachusetts, 01655

  • Tekton Research, LLC.

    Yukon, Oklahoma, 73099

Other trials in United States

South Africa29 sites

  • Worthwhile Clinical Trials

    Benoni, Gauteng, 1500

  • Iatros International

    Bloemfontein, Free State, 9301

  • Josha Research

    Bloemfontein, Free State, 9301

  • REIMED Reiger Park

    Boksburg, Gauteng, 1459

  • TREAD Research (Pty)Ltd

    Cape Town, Western Cape, 7500

  • TASK Applied Science

    Cape Town, Western Cape, 7530

  • Tiervlei Trial Centre

    Cape Town, Western Cape, 7530

  • TREAD Research

    Cape Town, Western Cape, 7530

  • Precise Clinical Solutions

    Chatsworth, KwaZulu-Natal, 4092

  • Private Practice - Dr. Peter Sebastian

    Chatsworth, KwaZulu-Natal, 4092

  • Synapta Clinical Research Centre

    Durban, KwaZulu-Natal, 4001

  • Synergy Biomed Research Institute

    East London, Eastern Cape, 5241

  • Soweto Clinical Trials Centre

    Johannesburg, Gauteng, 1818

  • Clinresco Centres

    Kempton Park, Gauteng, 1619

  • Ubuntu Clinical Research - Krugersdorp

    Krugersdorp, Gauteng, 1739

  • Ubuntu Clinical Research - Lenasia

    Lenasia, Gauteng, 1827

  • MERCLINCO Middleburg

    Middelburg, Mpumalanga, 1050

  • Zinakekele Medicall Centre

    Moloto, Gauteng, 1022

  • Phoenix Pharma

    Port Elizabeth, Eastern Cape, 6001

  • Emmed Research

    Pretoria, Gauteng, 0002

  • Setshaba Research Centre

    Pretoria, Gauteng, 0152

  • Global Clinical Trials

    Pretoria, Gauteng, 0157

  • Botho Ke Bontle Health Services

    Pretoria, Gauteng, 0184

  • Jongaie Research

    Pretoria West, Gauteng, 0183

  • Aurum Institute - Rustenburg

    Rustenburg, North West, 0299

  • Wits Clinical Research

    Soweto, Gauteng, 2013

  • Umzimkhulu Research Centre

    uMzimkhulu, 3297

  • Synexus Watermeyer Clinical Research Centre

    Val de Grace, Gauteng, 0184

  • FCRN Clinical Trial Centre

    Vereeniging, Gauteng, 1935

Other trials in South Africa

Philippines12 sites

  • De La Salle Medical and Health Sciences Institute

    Dasmariñas, 4114

  • De La Salle Health Sciences Institute

    Dasmariñas

  • West Visayas State University Medical Center

    Iloilo City, Iloilo, 5000

  • Iloilo Doctors' Hospital

    Iloilo City, 5000

  • St. Paul's Hospital of Iloilo, Inc.

    Iloilo City, 5000

  • Tropical Disease Foundation

    Makati City, National Capital Region, 1230

  • Health Cube Medical Clinics

    Mandaluyong, National Capital Region, 1552

  • Mary Johnston Hospital

    Manila, National Capital Region, 1012

  • Philippine General Hospital

    Manila, 1000

  • Adventist Hospital Palawan

    Puerto Princesa City, Palawan, 5300

  • Lung Center of the Philippines

    Quezon City, National Capital Region, 1100

  • Far Eastern University Nicanor Reyes Medical Foundation

    Quezon City, National Capital Region, 1118

Other trials in Philippines

New Zealand11 sites

  • Southern Clinical Trials Totara

    Auckland, 0600

  • Optimal Clinical Trials North

    Auckland, 0632

  • Optimal Clinical Trials

    Auckland, 1010

  • Pacific Clinical Research Network - Forte

    Christchurch, Canterbury, 8013

  • Lakeland Clinical Trials Waikato

    Hamilton, Waikato Region, 3200

  • P3 Research - Hawke's Bay

    Hastings, Hawke's Bay Region, 4122

  • Southern Clinical Trials Tasman

    Nelson, 7011

  • Pacific Clinical Research Network - Rotorua

    Rotorua, Bay of Plenty, 3010

  • P3 Research - Tauranga

    Tauranga, Bay of Plenty, 3110

  • Lakeland Clinical Trials Wellington

    Upper Hutt, Wellington Region, 5018

  • P3 Research - Wellington

    Wellington, 6021

Other trials in New Zealand

Argentina3 sites

  • Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

    Buenos Aires, 1426

  • Fundacion Estudios Clinicos

    Rosario, Santa Fe Province, S2000DEJ

  • Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

Chile3 sites

  • Enroll SpA

    Santiago, Santiago Metropolitan, 7500587

  • Centro Skin Med Limitada

    Santiago, Santiago Metropolitan, 7580206

  • CECIM

    Santiago, Santiago Metropolitan, 8330336

Other trials in Chile

About this study

Official title: 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.

Read the 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.

Being tested
Quadrivalent influenza modRNA vaccine, Quadrivalent influenza vaccine
Keywords
Grippe, Flu, Influenza, Vaccine, RNA vaccine
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quadrivalent influenza modRNA vaccineBiological

    Quadrivalent influenza modRNA vaccine (single dose)

  • Quadrivalent influenza vaccineBiological

    Licensed quadrivalent influenza vaccine (single dose)

Study groups in NCT05540522
Study groupRoleWhat they receive
Quadrivalent influenza modRNA vaccine, 18 through 64 years of ageExperimentalQuadrivalent influenza modRNA vaccine (single dose), participants 18 through 64 years of age
Receives: Biological: Quadrivalent influenza modRNA vaccine
Quadrivalent influenza vaccine, 18 through 64 years of ageActive comparatorLicensed quadrivalent influenza vaccine (single dose), participants 18 through 64 years of age
Receives: Biological: Quadrivalent influenza vaccine
Quadrivalent influenza modRNA vaccine, ≥65 years of ageExperimentalQuadrivalent influenza modRNA vaccine (single dose), participants ≥65 years of age
Receives: Biological: Quadrivalent influenza modRNA vaccine
Quadrivalent influenza vaccine, ≥65 years of ageActive comparatorLicensed quadrivalent influenza vaccine (single dose), participants ≥65 years of age
Receives: Biological: Quadrivalent influenza vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 15 to surveillance cut-off (approximately 6 months)

  2. 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.

    Measured: Day 15 up to primary surveillance cut-off (approximately 1 year)

  3. 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.

    Measured: From Day 1 to Day 7 after study vaccination

  4. 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.

    Measured: From Day 1 to Day 7 after study vaccination

  5. 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.

    Measured: From Day 1 to Day 7 after study vaccination

  6. 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.

    Measured: From Day 1 to Day 7 after study vaccination

  7. 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.

    Measured: From study vaccination on Day 1 through 4 weeks after study vaccination

  8. 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.

    Measured: From study vaccination on Day 1 through 4 weeks after study vaccination

  9. 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.

    Measured: From study vaccination on Day 1 through 4 weeks after study vaccination

  10. 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.

    Measured: From Day 1 up to 6 months after vaccination

  11. 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.

    Measured: From Day 1 up to 6 months after vaccination

  12. 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.

    Measured: From Day 1 up to 6 months after vaccination

Secondary outcomes (46)

  1. 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

    LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 to surveillance cut-off (approximately 6 months)

  2. 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

    LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 up to primary surveillance cut-off (approximately 1 year)

  3. 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

    CCI was defined as influenza infection confirmed through 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 symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 to surveillance cut-off (approximately 6 months)

  4. 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

    CCI was defined as influenza infection confirmed through 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 symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 up to primary surveillance cut-off (approximately 1 year)

  5. 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

    LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 to surveillance cut-off (approximately 6 months)

  6. Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by Modified CDC 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. ILI defined modified CDC: occurrence (new onset or worsening of preexisting condition) of at least 1 of the following respiratory symptoms concurrently with an oral temperature >37.2 deg C (>99.0 deg F), sore throat or cough. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 up to primary surveillance cut-off (approximately 1 year)

  7. Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by World Health Organization (WHO) Caused by Any Strain at Least 14 Days After Vaccination: 18-64 Years

    LCI was defined as influenza infection confirmed through RT-PCR or culture at the central laboratory, unless otherwise specified. ILI as per WHO was defined as occurrence (new onset or worsening of preexisting condition) of a cough concurrently with an oral temperature >=38.0 deg C (>= 100.4 deg F). Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 to surveillance cut-off (approximately 6 months)

  8. Percentage of Participants Reporting First Episode of LCI Cases With Associated ILI as Defined by WHO 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. ILI as per WHO was defined as occurrence (new onset or worsening of preexisting condition) of a cough concurrently with an oral temperature >=38.0 deg C (>= 100.4 deg F). Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 up to primary surveillance cut-off (approximately 1 year)

  9. Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: 18-64 Years

    Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 to surveillance cut-off (approximately 6 months)

  10. Percentage of Participants Reporting First Episode Cases of Influenza as Confirmed by Central RT-PCR or Local RT-PCR or Culture, With Associated Per-Protocol ILI at Least 14 Days After Vaccination: >=65 Years

    Per-protocol ILI was defined as occurrence (new onset or worsening of preexisting condition) of at least 1 respiratory symptom concurrently with at least 1 systemic symptom. Data was obtained during the 2022-2023 northern and southern hemisphere influenza season up to surveillance cut-off decided by Sponsor.

    Measured: Day 15 up to primary surveillance cut-off (approximately 1 year)

  11. HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV at 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years

    Geometric mean titers (GMTs) and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution) and were reported in the descriptive section. Geometric mean ratios (GMRs) were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.

    Measured: 4 Weeks after vaccination

  12. HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 2: >=65 Years

    GMTs and 2-sided 95% CIs were calculated by exponentiating the mean logarithm of the concentrations and the corresponding CIs (based on the student t distribution) and were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.

    Measured: 4 Weeks after vaccination

  13. Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.

    Measured: 4 Weeks after vaccination

  14. Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.

    Measured: 4 Weeks after vaccination

  15. HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination- Based on HAI Assay 1: 18-64 Years

    GMTs and 2-sided 95% CIs were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.

    Measured: 4 Weeks after vaccination

  16. HAI GMTs Used to Determine GMRs of qIRV to Licensed QIV for 2022-2023 Northern Hemisphere at 4 Weeks After Vaccination - Based on HAI Assay 1: >=65 Years

    GMTs and 2-sided 95% CIs were reported in the descriptive section. GMRs were estimated by the ratio of the GMTs between qIRV recipients compared to licensed QIV recipients vaccine groups and were reported in the statistical analysis section.

    Measured: 4 Weeks after vaccination

  17. Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere-Based on HAI Assay 1: 18-64 Years

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.

    Measured: 4 Weeks after vaccination

  18. Percentage of Participants and Difference in Percentage of Participants Achieving Seroconversion at 4 Weeks After Vaccination With qIRV and Licensed QIV for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest. Percentage of participants achieving seroconversion for each strain at 4 weeks after vaccination and exact 2-sided 95% CI is presented in the descriptive section. Difference in percentage of participants (qIRV - QIV) achieving HAI seroconversion for each strain at 4 weeks after vaccination is presented in the statistical analysis section.

    Measured: 4 Weeks after vaccination

  19. HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years

    Measured: Baseline (Before Vaccination)

  20. HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years

    Measured: Baseline (Before Vaccination)

  21. HAI Geometric Mean Fold Rise (GMFR) From Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years

    GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).

    Measured: Before vaccination (Baseline) to 4 weeks after vaccination

  22. HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years

    GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).

    Measured: Before vaccination (Baseline) to 4 weeks after vaccination

  23. Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: 18-64 Years

    Measured: Baseline and 4 weeks after vaccination

  24. Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years

    Measured: Baseline and 4 weeks after vaccination

  25. HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years

    Measured: Baseline

  26. HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years

    Measured: Baseline

  27. HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years

    GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).

    Measured: Before vaccination (Baseline) to 4 weeks after vaccination

  28. HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years

    GMFRs were defined as ratios of the results after vaccination to the results before vaccination.

    Measured: Before vaccination (Baseline) to 4 weeks after vaccination

  29. Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years

    Measured: Baseline and 4 weeks after vaccination

  30. Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: >=65 Years

    Measured: Baseline and 4 weeks after vaccination

  31. HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years

    Measured: Baseline and 4 weeks after vaccination

  32. HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years

    Measured: Baseline and 4 weeks after vaccination

  33. HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern- Based on HAI Assay 2: 18-64 Years

    Measured: Before vaccination (Baseline) to 4 weeks after vaccination

  34. HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years

    GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).

    Measured: Before vaccination (Baseline) to 4 weeks after vaccination

  35. Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years

    Measured: 4 weeks after vaccination

  36. Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest.

    Measured: 4 weeks after vaccination

  37. Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years

    Measured: Baseline and 4 weeks after vaccination

  38. Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years

    Measured: Baseline and 4 weeks after vaccination

  39. HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years

    Measured: Baseline and 4 weeks after vaccination

  40. HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years

    Measured: Baseline and 4 weeks after vaccination

  41. HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 1: 18-64 Years

    Measured: Before Vaccination (baseline) to 4 weeks after vaccination

  42. HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years

    GMFRs were defined as ratios of the results after vaccination to the results before vaccination (baseline).

    Measured: Before vaccination (baseline) to 4 weeks after vaccination

  43. Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years

    Measured: 4 weeks after vaccination

  44. Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years

    Seroconversion was defined as an HAI titer <1:10 prior to vaccination and >=1:40 at the time point of interest, or an HAI titer of >=1:10 prior to vaccination with a 4-fold rise at the time point of interest.

    Measured: 4 weeks after vaccination

  45. Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years

    Measured: Baseline and 4 weeks after vaccination

  46. Percentage of Participants With HAI Titers >=1:40 at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years

    Measured: Baseline and 4 weeks after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2022
  2. Study start12 Sep 2022
  3. Primary completion12 Mar 2024
  4. Study completion12 Mar 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
45,789 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05540522
Sponsor's protocol ID
C4781004
Other IDs
NCT05540522
Status last verified
Apr 2025
First submitted
8 Sep 2022
Last updated
8 May 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41259756

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quadrivalent influenza modRNA vaccine and Quadrivalent influenza vaccine in people with Influenza, Human, run by Pfizer at 321 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 321 sites in United States, South Africa, Philippines, New Zealand, Argentina and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05540522, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

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