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

Influenza, Human Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05540522
• Other study ID #: C4781004
• Status: Completed
• Phase: Phase 3
• Start date: September 12, 2022
• Est. completion date: March 12, 2024

Study information

• Verified date: April 2024
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46169
• Est. completion date: March 12, 2024
• Est. primary completion date: March 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female participants =18 years of age at Visit 1 (Day 1).

2. Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.

3. 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.

4. 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:

1. 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.

2. History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).

3. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

4. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.

5. Allergy to egg proteins (egg or egg products) or chicken proteins.

6. 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.

7. Receipt of blood/plasma products or immunoglobulin from 60 days before study intervention administration, or planned receipt throughout the study.

8. 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.

9. 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.

10. Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study.

11. 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.

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Biological:
• Quadrivalent influenza modRNA vaccine
Quadrivalent influenza modRNA vaccine (single dose)
• Quadrivalent influenza vaccine
Licensed quadrivalent influenza vaccine (single dose)

Locations

Country	Name	City	State
Argentina	Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich	Buenos Aires
Argentina	Fundacion Estudios Clinicos	Rosario	Santa FE
Argentina	Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L	San Miguel de Tucuman	Tucumán
Brazil	Infection Control	Belo Horizonte	Minas Gerais
Brazil	Centro de Estudos e Pesquisa em Molestias Infecciosas - CPCLIN/RN	Natal	RIO Grande DO Norte
Brazil	Obras Sociais Irma Dulce	Salvador	Bahia
Brazil	Centro de Referência e Treinamento DST/AIDS	Sao Paulo	SÃO Paulo
Brazil	CEPIC - Centro Paulista de Investigação Clínica	São Paulo
Brazil	Instituto de Infectologia Emilio Ribas	São Paulo
Brazil	A2Z Clinical Centro Avançado de Pesquisa Clínica - Valinhos	Valinhos	SÃO Paulo
Chile	CECIM	Santiago	Región Metropolitana DE Santiago
Chile	Centro Skin Med Limitada	Santiago	Región Metropolitana DE Santiago
Chile	Enroll SpA	Santiago	Región Metropolitana DE Santiago
Chile	Clinical Research Chile SpA	Valdivia	Los Ríos
New Zealand	Optimal Clinical Trials	Auckland
New Zealand	Optimal Clinical Trials North	Auckland
New Zealand	Southern Clinical Trials Totara	Auckland
New Zealand	Pacific Clinical Research Network - Forte	Christchurch	Canterbury
New Zealand	Lakeland Clinical Trials Waikato	Hamilton	Waikato
New Zealand	P3 Research - Hawke's Bay	Hastings	Hawke's BAY
New Zealand	Southern Clinical Trials Tasman	Nelson
New Zealand	Pacific Clinical Research Network - Rotorua	Rotorua	BAY OF Plenty
New Zealand	P3 Research - Tauranga	Tauranga	BAY OF Plenty
New Zealand	Lakeland Clinical Trials Wellington	Upper Hutt	Wellington
New Zealand	P3 Research - Wellington	Wellington
Philippines	Cebu Doctors University Hospital	Cebu
Philippines	De La Salle Medical and Health Sciences Institute	Dasmarinas
Philippines	De La Salle Health Sciences Institute	Dasmarinas City
Philippines	Iloilo Doctors' Hospital	Iloilo
Philippines	St. Paul's Hospital of Iloilo Inc.	Iloilo City
Philippines	St. Paul's Hospital of Iloilo, Inc.	Iloilo City
Philippines	West Visayas State University Medical Center	Iloilo City	Iloilo
Philippines	Tropical Disease Foundation	Makati	National Capital Region
Philippines	Health Cube Medical Clinics	Mandaluyong	Metro Manila
Philippines	Mary Johnston Hospital	Manila	National Capital Region
Philippines	Philippine General Hospital	Manila
Philippines	Adventist Hospital Palawan	Puerto Princesa	Palawan
Philippines	Far Eastern University Nicanor Reyes Medical Foundation	Quezon City
Philippines	Far Eastern University Nicanor Reyes Medical Foundation	Quezon City	National Capital Region
Philippines	Lung Center of the Philippines	Quezon City	National Capital Region
South Africa	Global Clinical Trials	Arcadia, Pretoria	Gauteng
South Africa	Worthwhile Clinical Trials	Benoni	Gauteng
South Africa	Iatros International	Bloemfontein	FREE State
South Africa	Josha Research	Bloemfontein	FREE State
South Africa	Reimed	Boksburg	Gauteng
South Africa	REIMED Reiger Park	Boksburg	Gauteng
South Africa	Synexus - Helderberg Clinical Research Centre - Somerset West	Cape Town	Western CAPE
South Africa	TASK Applied Science	Cape Town	Western CAPE
South Africa	Tiervlei Trial Centre	Cape Town	Western CAPE
South Africa	TREAD Research	Cape Town	Western CAPE
South Africa	TREAD Research	Cape Town	Western CAPE
South Africa	TREAD Research (Pty)Ltd	Cape Town	Western CAPE
South Africa	Precise Clinical Solutions	Chatsworth	Kwazulu-natal
South Africa	Private Practice - Dr. Peter Sebastian	Chatsworth	Kwazulu-natal
South Africa	Ndlovu Research Centre	Dennilton	Limpopo
South Africa	Private Practice - Dr. Neyaseelan Gounden	Durban	Kwazulu-natal
South Africa	Synapta Clinical Research Centre	Durban	Kwazulu-natal
South Africa	Synergy Biomed Research Institute	East London	Eastern CAPE
South Africa	Soweto Clinical Trials Centre	Johannesburg	Gauteng
South Africa	Wits Clinical Research	Johannesburg	Gauteng
South Africa	Clinresco Centres	Kempton Park	Gauteng
South Africa	Ubuntu Clinical Research - Krugersdorp	Krugersdorp	Gauteng
South Africa	Ubuntu Clinical Research - Lenasia	Lenasia	Gauteng
South Africa	MERCLINCO Middleburg	Middelburg	Mpumalanga
South Africa	Zinakekele Medicall Centre	Moloto	Gauteng
South Africa	Nelson Mandela Academic Clinical Research Unit (NeMACRU)	Mthatha	Eastern CAPE
South Africa	Phoenix Pharma	Port Elizabeth	Eastern CAPE
South Africa	Botho Ke Bontle Health Services	Pretoria	Gauteng
South Africa	Emmed Research	Pretoria	Gauteng
South Africa	Global Clinical Trials	Pretoria	Gauteng
South Africa	Jongaie Research	Pretoria West	Gauteng
South Africa	Aurum Institute - Rustenburg	Rustenburg	North-west
South Africa	Setshaba Research Centre	Soshanguve
South Africa	Wits Clinical Research	Soweto	Gauteng
South Africa	Setshaba Research Centre	Tshwane	Gauteng
South Africa	Umzimkhulu Research Centre	uMzimkhulu
South Africa	Synexus Watermeyer Clinical Research Centre	Val De Grace	Gauteng
South Africa	FCRN Clinical Trial Centre	Vereeniging, Three Rivers	Gauteng
United States	Albuquerque Clinical Trials, Inc.	Albuquerque	New Mexico
United States	Velocity Clinical Research, Albuquerqu	Albuquerque	New Mexico
United States	Velocity Clinical Research, Albuquerque	Albuquerque	New Mexico
United States	Velocity Clinical Research, Albuquerque	Albuquerque	New Mexico
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	Anaheim Clinical Trials	Anaheim	California
United States	Velocity Clinical Research, Anderson	Anderson	South Carolina
United States	Clinical Alliance for Research and Education - Infectious Diseases (CARE-ID), LLC	Annandale	Virginia
United States	North Alabama Research Center	Athens	Alabama
United States	JEM Research Institute	Atlantis	Florida
United States	Lynn Institute of Denver	Aurora	Colorado
United States	Benchmark Research	Austin	Texas
United States	Elligo Clinical Research Center	Austin	Texas
United States	Elligo Clinical Research Center	Austin	Texas
United States	Orion Clinical Research	Austin	Texas
United States	Tekton Research, LLC.	Austin	Texas
United States	Velocity Clinical Research, Austin	Austin	Texas
United States	Pharmaron	Baltimore	Maryland
United States	Velocity Clinical Research, Banning	Banning	California
United States	Accel Research Sites - Birmingham Clinical Research Unit	Birmingham	Alabama
United States	Accel Research Sites Network - Birmingham Clinical Research Unit	Birmingham	Alabama
United States	Ross Bridge Medical Practice, LLC-CCT Research	Birmingham	Alabama
United States	St. Vincent's Birmingham Hospital	Birmingham	Alabama
United States	Boston Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cope Family Medicine / CCT Research	Bountiful	Utah
United States	Bozeman Health Deaconess Hospital	Bozeman	Montana
United States	New England Research Associates, LLC	Bridgeport	Connecticut
United States	Accellacare - Bristol	Bristol	Tennessee
United States	Internal Medicine and Pediatric Associates of Bristol	Bristol	Tennessee
United States	Headlands Research - Brownsville	Brownsville	Texas
United States	Capital Area Research, LLC	Camp Hill	Pennsylvania
United States	Accellacare - Cary	Cary	North Carolina
United States	Velocity Clinical Research, Austin	Cedar Park	Texas
United States	Pharmacorp Clinical Trials	Charleston	South Carolina
United States	Accellacare - Charlotte	Charlotte	North Carolina
United States	Accellacare - Charlotte	Charlotte	North Carolina
United States	Charlottesville Medical Research	Charlottesville	Virginia
United States	WR-Clinsearch, LLC	Chattanooga	Tennessee
United States	Clinical Research Professionals	Chesterfield	Missouri
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Meridian Clinical Research, LLC	Cincinnati	Ohio
United States	Velocity Clinical Research, Mt. Auburn	Cincinnati	Ohio
United States	Tampa Bay Medical Research	Clearwater	Florida
United States	Senders Pediatrics	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Velocity Clinical Research, Cleveland	Cleveland	Ohio
United States	Benchmark Research	Colton	California
United States	Velocity Clinical Research, Columbia	Columbia	South Carolina
United States	Centricity Research Columbus Georgia Multispecialty	Columbus	Georgia
United States	Centricity Research Columbus Ohio Multispecialty	Columbus	Ohio
United States	Alliance for Multispecialty Research, LLC	Coral Gables	Florida
United States	DFW Clinical Research	Dallas	Texas
United States	North Texas Infectious Diseases Consultants, P.A	Dallas	Texas
United States	WR-Global Medical Research, LLC	Dallas	Texas
United States	Dayton Clinical Research	Dayton	Ohio
United States	Hometown Urgent Care & Occupational Health	Dayton	Ohio
United States	PriMED Clinical Research	Dayton	Ohio
United States	PriMED Clinical Research	Dayton	Ohio
United States	WellNow Urgent Care & Research	Dayton	Ohio
United States	Epic Medical Research - DeSoto	DeSoto	Texas
United States	Henry Ford Hospital	Detroit	Michigan
United States	Universal Axon Clinical Research, LLC	Doral	Florida
United States	SEC Clinical Research	Dothan	Alabama
United States	Velocity Clinical Research, Providence	East Greenwich	Rhode Island
United States	Proactive Clinical Research, LLC	Edinburg	Texas
United States	Tekton Research, Inc	Edmond	Oklahoma
United States	Tekton Research, LLC.	Edmond	Oklahoma
United States	Central Erie Primary Care	Erie	Pennsylvania
United States	MediSphere Medical Research Center - EAST	Evansville	Indiana
United States	MediSphere Medical Research Center - Evansville - West Franklin Street	Evansville	Indiana
United States	Plains Clinical Research Center	Fargo	North Dakota
United States	Plains Medical Clinic, LLC	Fargo	North Dakota
United States	Carolina Institute for Clinical Research	Fayetteville	North Carolina
United States	Fleming Island Center for Clinical Research	Fleming Island	Florida
United States	Tekton Research, Inc	Fort Collins	Colorado
United States	Tekton Research, LLC	Fort Collins	Colorado
United States	Proactive Clinical Research,LLC	Fort Lauderdale	Florida
United States	Alliance for Multispecialty Research, LLC	Fort Myers	Florida
United States	Robert B. Pritt, DO	Fort Myers	Florida
United States	Benchmark Research	Fort Worth	Texas
United States	Texas Health Family Care	Fort Worth	Texas
United States	Methodist Physicians Clinic/CCT Research	Fremont	Nebraska
United States	Allure Health	Friendswood	Texas
United States	Ascada Health PC dba Ascada Research	Fullerton	California
United States	Ascada Research	Fullerton	California
United States	Velocity Clinical Research, Gaffney	Gaffney	South Carolina
United States	Lenzmeier Family Medicine/CCT Research	Glendale	Arizona
United States	Velocity Clinical Research, Grand Island	Grand Island	Nebraska
United States	PharmQuest Life Sciences, LLC	Greensboro	North Carolina
United States	Tribe Clinical Research, LLC	Greenville	South Carolina
United States	Ascension St. John Hospital	Grosse Pointe Woods	Michigan
United States	Lakeview Clinical Research	Guntersville	Alabama
United States	David Jurist Research Building	Hackensack	New Jersey
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Hackensack University Medical Center Medical Plaza	Hackensack	New Jersey
United States	Best Quality Research,Inc.	Hialeah	Florida
United States	Accellacare - Hickory	Hickory	North Carolina
United States	East-West Medical Research Institute	Honolulu	Hawaii
United States	Smith Allergy & Asthma Specialists	Horseheads	New York
United States	DM Clinical Research - Bellaire	Houston	Texas
United States	Juno Research	Houston	Texas
United States	Prolato Clinical Research Center	Houston	Texas
United States	Santa Clara Family Clinic	Houston	Texas
United States	Texas Center for Drug Development, Inc.	Houston	Texas
United States	Trio Clinical Trials	Houston	Texas
United States	Dynamed Clinical Research, LP d/b/a DM Clinical Research	Humble	Texas
United States	Marvel Clinical Research	Huntington Beach	California
United States	Velocity Clinical Research, Huntington Park	Huntington Park	California
United States	Medical Affiliated Research Center	Huntsville	Alabama
United States	Clinical Research Prime	Idaho Falls	Idaho
United States	University of Iowa	Iowa City	Iowa
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Jacksonville	Florida
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Health Awareness	Jupiter	Florida
United States	Holston Medical Group	Kingsport	Tennessee
United States	EvergreenHealth	Kirkland	Washington
United States	EvergreenHealth Medical Center	Kirkland	Washington
United States	Accellacare US Inc., d/b/a Accellacare of Knoxville	Knoxville	Tennessee
United States	Accellacare US Inc., d/b/a Accellacare of Knoxville	Knoxville	Tennessee
United States	Alliance for Multispecialty Research, LLC	Knoxville	Tennessee
United States	New Phase Research and Development	Knoxville	Tennessee
United States	PMG Research, Inc. d/b/a PMG Research of Knoxville	Knoxville	Tennessee
United States	Velocity Clinical Research, San Diego	La Mesa	California
United States	MedPharmics, LLC	Lafayette	Louisiana
United States	Wr-Msra.Llc	Lake City	Florida
United States	Orange County Research Center	Lake Forest	California
United States	JEM Research Institute	Lake Worth	Florida
United States	Accel Research Sites Network - Lakeland Clinical Research Unit	Lakeland	Florida
United States	Andres Garcia Zuniga, M.D., P.A.	Laredo	Texas
United States	Milton Haber, MD - Research	Laredo	Texas
United States	Accel Research Sites - St. Petersburg Clinical Research Unit	Largo	Florida
United States	Accel Research Sites Network - St. Pete-Largo Clinical Research Unit	Largo	Florida
United States	Excel Clinical Research, LLC	Las Vegas	Nevada
United States	Santa Rosa Medical Centers of Nevada / CCT Research	Las Vegas	Nevada
United States	Alliance for Multispecialty Research, LLC	Lexington	Kentucky
United States	Be Well Clinical Studies	Lincoln	Nebraska
United States	Main Street Physician's Care	Little River	South Carolina
United States	Applied Research Center of Arkansas	Little Rock	Arkansas
United States	Baptist Health Center for Clinical Research	Little Rock	Arkansas
United States	Ark Clinical Research	Long Beach	California
United States	Ark Clinical Research	Long Beach	California
United States	Tekton Research, LLC.	Longmont	Colorado
United States	Kaiser Permanente	Los Angeles	California
United States	Velocity Clinical Research, Westlake	Los Angeles	California
United States	Velocity Clinical Research, Westlake.	Los Angeles	California
United States	Accel Research Sites Network - Maitland Clinical Research Unit	Maitland	Florida
United States	Velocity Clinical Research, Medford	Medford	Oregon
United States	Clinical Neuroscience Solutions Inc.	Memphis	Tennessee
United States	Clinical Neuroscience Solutions, Inc. dba CNS Healthcare	Memphis	Tennessee
United States	Solaris Clinical Research	Meridian	Idaho
United States	Aventiv Research	Mesa	Arizona
United States	Desert Clinical Research/ CCT Research	Mesa	Arizona
United States	SMS Clinical Research	Mesquite	Texas
United States	ActivMed Practices and Research	Methuen	Massachusetts
United States	Care Research - West Flagler Street	Miami	Florida
United States	Care Research Center Inc	Miami	Florida
United States	Entrust Clinical Research	Miami	Florida
United States	Gerardo Polanco, MD	Miami	Florida
United States	Miami Dade Medical Research Institute, LLC	Miami	Florida
United States	Palm Springs Community Health Center	Miami Lakes	Florida
United States	Palm Springs Community Health Center	Miami Lakes	Florida
United States	Virginia Research Center	Midlothian	Virginia
United States	Clinical Research Consulting	Milford	Connecticut
United States	Clinical Trials of South Carolina	Moncks Corner	South Carolina
United States	Monroe Biomedical Research	Monroe	North Carolina
United States	Tekton Research, LLC.	Moore	Oklahoma
United States	Koch Family Medicine	Morton	Illinois
United States	Trial Management Associates	Myrtle Beach	South Carolina
United States	New Haven Clinical Research Unit	New Haven	Connecticut
United States	Yale Cardiology	New Haven	Connecticut
United States	Yale University School of Medicine	New Haven	Connecticut
United States	Alliance for Multispecialty Research, LLC	New Orleans	Louisiana
United States	DelRicht Research	New Orleans	Louisiana
United States	NYU Langone Health	New York	New York
United States	Health Research of Hampton Roads, Inc.	Newport News	Virginia
United States	Alliance for Multispecialty Research, LLC	Newton	Kansas
United States	Alliance for Multispecialty Research, LLC	Norfolk	Virginia
United States	Velocity Clinical Research, Norfolk	Norfolk	Nebraska
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Coastal Carolina Research Center	North Charleston	South Carolina
United States	Velocity Clinical Research, North Hollywood	North Hollywood	California
United States	Accellacare - DuPage	Oak Lawn	Illinois
United States	South Ogden Family Medicine/ CCT Research	Ogden	Utah
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Quality Clinical Research	Omaha	Nebraska
United States	Velocity Clinical Research, Omaha	Omaha	Nebraska
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Headlands Research Orlando	Orlando	Florida
United States	Innovation Medical Research Center	Palmetto Bay	Florida
United States	Papillion Research Center/CCT Research	Papillion	Nebraska
United States	Center for Clinical Trials, LLC	Paramount	California
United States	DBC Research USA	Pembroke Pines	Florida
United States	Dignity Health Medical Group Family Medicine - St. Joseph's	Phoenix	Arizona
United States	Foothills Research Center/ CCT Research	Phoenix	Arizona
United States	HOPE Research Institute	Phoenix	Arizona
United States	HOPE Research Institute	Phoenix	Arizona
United States	HOPE Research Institute - Phoenix	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	The Pain Center of Arizona	Phoenix	Arizona
United States	AIM Trials, LLC	Plano	Texas
United States	Empire Clinical Research	Pomona	California
United States	United Medical Research	Port Orange	Florida
United States	Kaiser Permanente Northwest Center for Health Research	Portland	Oregon
United States	ActivMed Practices & Research, LLC.	Portsmouth	New Hampshire
United States	Meridian Clinical Research LLC	Portsmouth	Virginia
United States	Accellacare - Raleigh	Raleigh	North Carolina
United States	M3 Wake Research, Inc.	Raleigh	North Carolina
United States	Epic Medical Research	Red Oak	Texas
United States	Paradigm Clinical Research Centers, Inc	Redding	California
United States	Rainier Clinical Research Center	Renton	Washington
United States	Clinical Research Partners, LLC	Richmond	Virginia
United States	Centricity Research Rincon Pulmonology	Rincon	Georgia
United States	IACT Health	Rincon	Georgia
United States	Rochester Clinical Research, LLC	Rochester	New York
United States	Advanced Primary and Geriatric Care - CCT Research	Rockville	Maryland
United States	Accellacare - Rocky Mount	Rocky Mount	North Carolina
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	Benchmark Research	Sacramento	California
United States	Saint Louis University Center for Vaccine Development	Saint Louis	Missouri
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Accel Research Sites - St. Petersburg Clinical Research Unit	Saint Petersburg	Florida
United States	Accellacare - Salisbury	Salisbury	North Carolina
United States	J. Lewis Research, Inc. / Foothill Family Clinic	Salt Lake City	Utah
United States	J. Lewis Research, Inc. / Foothill Family Clinic South	Salt Lake City	Utah
United States	Olympus Family Medicine/CCT Research	Salt Lake City	Utah
United States	Clinical Trials of Texas, LLC	San Antonio	Texas
United States	IMA Clinical Research San Antonio	San Antonio	Texas
United States	Tekton Research - Fredericksburg Road	San Antonio	Texas
United States	Tekton Research, LLC.	San Antonio	Texas
United States	Artemis Institute for Clinical Research	San Diego	California
United States	California Research Foundation	San Diego	California
United States	Wr-McCr, Llc	San Diego	California
United States	AGILE Clinical Research Trials, LLC	Sandy Springs	Georgia
United States	WR-Mount Vernon Clinical Research, LLC	Sandy Springs	Georgia
United States	CenExel iResearch, LLC	Savannah	Georgia
United States	Javara - Privia Medical Group Georgia - Savannah	Savannah	Georgia
United States	Velocity Clinical Research, Savannah	Savannah	Georgia
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington
United States	Seattle Clinical Research Center	Seattle	Washington
United States	Louisiana State University Health Sciences Shreveport	Shreveport	Louisiana
United States	Jadestone Clinical Research	Silver Spring	Maryland
United States	Velocity Clinical Research, Sioux City	Sioux City	Iowa
United States	South Jersey Infectious Disease	Somers Point	New Jersey
United States	J. Lewis Research, Inc. / Jordan River Family Medicine	South Jordan	Utah
United States	Velocity Clinical Research, Spartanburg	Spartanburg	South Carolina
United States	Encompass Clinical Research	Spring Valley	California
United States	Bio-Kinetic Clinical Applications, LLD dba QPS-MO	Springfield	Missouri
United States	QPS Bio-Kinetic Clinical Applications (Patient Screening Only)	Springfield	Missouri
United States	Springville Dermatology - Springville/CCT Research	Springville	Utah
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	Javara - Privia Medical Group North Texas - Stephenville	Stephenville	Texas
United States	Revival Research Institute	Sterling Heights	Michigan
United States	Clinical Research Atlanta	Stockbridge	Georgia
United States	Centricity Research Suffolk Primary Care	Suffolk	Virginia
United States	Sugar Lakes Family Practice, PA	Sugar Land	Texas
United States	Epic Medical Research - Surprise	Surprise	Arizona
United States	Angels Clinical Research Institute	Tampa	Florida
United States	Genesis Clinical Research, LLC	Tampa	Florida
United States	Fiel Family and Sports Medicine, PC/CCT Research	Tempe	Arizona
United States	HOPE Research Institute	Tempe	Arizona
United States	Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.	Toluca Lake	California
United States	Premiere Medical Center	Toluca Lake	California
United States	DM Clinical Research	Tomball	Texas
United States	Northwest Houston Heart Center	Tomball	Texas
United States	Collaborative Neuroscience Research, LLC	Torrance	California
United States	Collaborative Neuroscience Research, LLC	Torrance	California
United States	Arcturus Healthcare , PLC, Troy Internal Medicine Research Division	Troy	Michigan
United States	Oakland Medical Research	Troy	Michigan
United States	WellNow Urgent Care and Research	Troy	Ohio
United States	Noble Clinical Research	Tucson	Arizona
United States	Ark Clinical Research - Tustin	Tustin	California
United States	Orange County Research Center	Tustin	California
United States	Velocity Clinical Research, Union	Union	South Carolina
United States	Rophe Adult and Pediatric Medicine/SKYCRNG	Union City	Georgia
United States	Velocity Clinical Research, Valparaiso	Valparaiso	Indiana
United States	Versailles Family Medicine / CCT Research	Versailles	Kentucky
United States	Velocity Clinical Research, Vestal	Vestal	New York
United States	Crossroads Clinical Research	Victoria	Texas
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Washington Health Institute	Washington	District of Columbia
United States	Allegiance Research Specialists, LLC	Wauwatosa	Wisconsin
United States	Velocity Clinical Research, Salt Lake City	West Jordan	Utah
United States	Paradigm Clinical Research Centers, Inc	Wheat Ridge	Colorado
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas
United States	Alliance for Multispecialty Research, LLC	Wichita	Kansas
United States	Accellacare - Wilmington	Wilmington	North Carolina
United States	Trial Management Associates - Wilmington - Floral Parkway	Wilmington	North Carolina
United States	Trial Management Associates, LLC	Wilmington	North Carolina
United States	Accellacare - Winston-Salem	Winston-Salem	North Carolina
United States	Clinical Site Partners, LLC dba Flourish Research	Winter Park	Florida
United States	University of Massachusetts Chan Medical School	Worcester	Massachusetts
United States	Tekton Research, Inc	Yukon	Oklahoma
United States	Tekton Research, LLC.	Yukon	Oklahoma
United States	Tekton/ Primary Health Partners	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Brazil,  Chile,  New Zealand,  Philippines,  South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of participants reporting laboratory-confirmed influenza (LCI) cases with associated per-protocol influenza-like illness (ILI) in each vaccine group, 18 through 64 years of age	As measured at the central laboratory	At least 14 days after vaccination
Primary	The proportion of participants reporting laboratory-confirmed influenza (LCI) cases with associated per-protocol influenza-like illness (ILI) in each vaccine group, =65 years of age	As measured at the central laboratory	At least 14 days after vaccination
Primary	Percentage of participants reporting local reactions, 18 through 64 years of age and =65 years of age separately	Pain at the injection site, redness, and swelling	For up to 7 days following vaccination
Primary	Percentage of participants reporting systemic events, 18 through 64 years of age and =65 years of age separately	Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain	For up to 7 days following vaccination
Primary	Percentage of participants reporting adverse events, 18 through 64 years of age and =65 years of age separately and combined	As elicited by investigational site staff	From the time the participant provides informed consent through 4 weeks after vaccination
Primary	Percentage of participants reporting serious adverse events, 18 through 64 years of age and =65 years of age separately and combined	As elicited by investigational site staff	From the time the participant provides informed consent through 6 months after vaccination
Secondary	The proportion of participants reporting LCI cases with associated per-protocol ILI caused by all matched strains, each matched strain, or unmatched strains in each vaccine group, 18 through 64 years of age and =65 years of age separately	As measured at the central laboratory	At least 14 days after vaccination
Secondary	The proportion of participants reporting culture-confirmed influenza (CCI) cases with associated per-protocol ILI in each vaccine group, 18 through 64 years of age and =65 years of age separately	As measured at the central laboratory	At least 14 days after vaccination
Secondary	The proportion of participants reporting LCI associated with ILI, as defined by applying a modified CDC definition, in each vaccine group, 18 through 64 years of age and =65 years of age separately	As measured at the central laboratory	At least 14 days after vaccination
Secondary	The proportion of participants reporting LCI cases associated with ILI, as defined by applying the WHO definition, in each vaccine group, 18 through 64 years of age and =65 years of age separately	As measured at the central laboratory	At least 14 days after vaccination
Secondary	The proportion of participants reporting cases of influenza, as confirmed by central RT-PCR, local RT-PCR or culture, with associated per-protocol ILI in each vaccine group, 18 through 64 years of age and =65 years of age separately	As measured at the central laboratory	At least 14 days after vaccination
Secondary	Geometric mean ratio (GMR) of hemagglutination inhibition (HAI) titers for each strain in qIRV recipients compared to QIV recipients, 18 through 64 and =65 years of age separately	As measured at the central laboratory	4 weeks after vaccination
Secondary	Difference in percentage of participants achieving seroconversion for each strain between qIRV recipients and QIV recipients, 18 through 64 and =65 years of age separately	As measured at the central laboratory	4 weeks after vaccination
Secondary	HAI geometric mean titers (GMTs) for each strain, 18 through 64 years of age and =65 years of age separately	As measured at the central laboratory	4 weeks after vaccination
Secondary	HAI geometric mean fold rise (GMFR) for each strain, 18 through 64 years of age and =65 years of age separately	As measured at the central laboratory	4 weeks after vaccination
Secondary	The proportion of participants achieving HAI seroconversion for each strain, 18 through 64 years of age and =65 years of age separately	As measured at the central laboratory	4 weeks after vaccination
Secondary	The proportion of participants with HAI titers =1:40 for each strain, 18 through 64 years of age and =65 years of age separately	As measured at the central laboratory	Baseline and 4 weeks after vaccination

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