Clinical trial NCT05540522: A Study to Evaluate a Modified RNA Vaccine Against Influenza in Adults 18 Years of Age or Older
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza, Human
Keywords: Grippe
Flu
Influenza
Vaccine
RNA vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-09-14
Enrollment: 45789
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a Phase 3, randomized, observer-blinded study to evaluate the efficacy, safety, tolerability, and immunogenicity of a single dose of a quadrivalent influenza modRNA vaccine compared to licensed inactivated influenza vaccine in healthy adults 18 years of age and older.

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.

Eligibility criteria: 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.

Primary outcomes:
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
timeFrame: Day 15 to surveillance cut-off (approximately 6 months)
measure: 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
timeFrame: Day 15 up to primary surveillance cut-off (approximately 1 year)
measure: Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: 18-64 Years
timeFrame: From Day 1 to Day 7 after study vaccination
measure: Percentage of Participants Reporting Any Local Reactions Within 7 Days After Study Vaccination: >=65 Years
timeFrame: From Day 1 to Day 7 after study vaccination
measure: Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: 18-64 Years
timeFrame: From Day 1 to Day 7 after study vaccination
measure: Percentage of Participants Reporting Any Systemic Events Within 7 Days After Study Vaccination: >=65 Years
timeFrame: From Day 1 to Day 7 after study vaccination
measure: Percentage of Participants Reporting Adverse Events (AEs) From Study Vaccination Through 4 Weeks After Study Vaccination: 18-64 Years
timeFrame: From study vaccination on Day 1 through 4 weeks after study vaccination
measure: Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=65 Years
timeFrame: From study vaccination on Day 1 through 4 weeks after study vaccination
measure: Percentage of Participants Reporting AEs From Study Vaccination Through 4 Weeks After Study Vaccination: >=18 Years
timeFrame: From study vaccination on Day 1 through 4 weeks after study vaccination
measure: Percentage of Participants Reporting Serious Adverse Events (SAEs) From Study Vaccination Through 6 Months After Study Vaccination: 18-64 Years
timeFrame: From Day 1 up to 6 months after vaccination
measure: Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=65 Years
timeFrame: From Day 1 up to 6 months after vaccination
measure: Percentage of Participants Reporting SAEs From Study Vaccination Through 6 Months After Study Vaccination: >=18 Years
timeFrame: From Day 1 up to 6 months after vaccination
Secondary outcomes:
measure: 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
timeFrame: Day 15 to surveillance cut-off (approximately 6 months)
measure: 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
timeFrame: Day 15 up to primary surveillance cut-off (approximately 1 year)
measure: 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
timeFrame: Day 15 to surveillance cut-off (approximately 6 months)
measure: 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
timeFrame: Day 15 up to primary surveillance cut-off (approximately 1 year)
measure: 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
timeFrame: Day 15 to surveillance cut-off (approximately 6 months)
measure: 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
timeFrame: Day 15 up to primary surveillance cut-off (approximately 1 year)
measure: 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
timeFrame: Day 15 to surveillance cut-off (approximately 6 months)
measure: 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
timeFrame: Day 15 up to primary surveillance cut-off (approximately 1 year)
measure: 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
timeFrame: Day 15 to surveillance cut-off (approximately 6 months)
measure: 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
timeFrame: Day 15 up to primary surveillance cut-off (approximately 1 year)
measure: 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
timeFrame: 4 Weeks after vaccination
measure: 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
timeFrame: 4 Weeks after vaccination
measure: 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
timeFrame: 4 Weeks after vaccination
measure: 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
timeFrame: 4 Weeks after vaccination
measure: 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
timeFrame: 4 Weeks after vaccination
measure: 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
timeFrame: 4 Weeks after vaccination
measure: 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
timeFrame: 4 Weeks after vaccination
measure: 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
timeFrame: 4 Weeks after vaccination
measure: HAI GMTs at Baseline for the 2022-2023 Northern Hemisphere - Based on HAI Assay 2: 18-64 Years
timeFrame: Baseline (Before Vaccination)
measure: HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 2: >=65 Years
timeFrame: Baseline (Before Vaccination)
measure: 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
timeFrame: Before vaccination (Baseline) to 4 weeks after vaccination
measure: HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 2: >=65 Years
timeFrame: Before vaccination (Baseline) to 4 weeks after vaccination
measure: 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
timeFrame: Baseline and 4 weeks after vaccination
measure: 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
timeFrame: Baseline and 4 weeks after vaccination
measure: HAI GMTs at Baseline for 2022-2023 Northern Hemisphere - Based on HAI Assay 1: 18-64 Years
timeFrame: Baseline
measure: HAI GMTs at Baseline for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
timeFrame: Baseline
measure: HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: 18-64 Years
timeFrame: Before vaccination (Baseline) to 4 weeks after vaccination
measure: HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2022-2023 Northern Hemisphere- Based on HAI Assay 1: >=65 Years
timeFrame: Before vaccination (Baseline) to 4 weeks after vaccination
measure: 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
timeFrame: Baseline and 4 weeks after vaccination
measure: 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
timeFrame: Baseline and 4 weeks after vaccination
measure: HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years
timeFrame: Baseline and 4 weeks after vaccination
measure: HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 2: >=65 Years
timeFrame: Baseline and 4 weeks after vaccination
measure: HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern- Based on HAI Assay 2: 18-64 Years
timeFrame: Before vaccination (Baseline) to 4 weeks after vaccination
measure: HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
timeFrame: Before vaccination (Baseline) to 4 weeks after vaccination
measure: Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 2: 18-64 Years
timeFrame: 4 weeks after vaccination
measure: Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 2: >=65 Years
timeFrame: 4 weeks after vaccination
measure: 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
timeFrame: Baseline and 4 weeks after vaccination
measure: 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
timeFrame: Baseline and 4 weeks after vaccination
measure: HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
timeFrame: Baseline and 4 weeks after vaccination
measure: HAI GMTs at Baseline and 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
timeFrame: Baseline and 4 weeks after vaccination
measure: HAI GMFR Before Vaccination to 4 Weeks After Vaccination for 2023 Southern Hemisphere- Based on HAI Assay 1: 18-64 Years
timeFrame: Before Vaccination (baseline) to 4 weeks after vaccination
measure: HAI GMFR Before Vaccination to 4 Weeks After Vaccination for the 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
timeFrame: Before vaccination (baseline) to 4 weeks after vaccination
measure: Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: 18-64 Years
timeFrame: 4 weeks after vaccination
measure: Percentage of Participants Achieving HAI Seroconversion at 4 Weeks After Vaccination for 2023 Southern Hemisphere - Based on HAI Assay 1: >=65 Years
timeFrame: 4 weeks after vaccination
measure: 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
timeFrame: Baseline and 4 weeks after vaccination
measure: 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
timeFrame: Baseline and 4 weeks after vaccination
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center
state: Alabama
city: Birmingham
country: United States
facility: St. Vincent's Birmingham Hospital
state: Alabama
city: Birmingham
country: United States
facility: Accel Research Sites Network - Birmingham Clinical Research Unit
state: Alabama
city: Birmingham
country: United States
facility: Ross Bridge Medical Practice, LLC-CCT Research
state: Alabama
city: Dothan
country: United States
facility: SEC Clinical Research
state: Alabama
city: Guntersville
country: United States
facility: Lakeview Clinical Research
state: Alabama
city: Huntsville
country: United States
facility: Medical Affiliated Research Center
state: Alabama
city: Glendale
country: United States
facility: Lenzmeier Family Medicine/CCT Research
state: Arizona
city: Mesa
country: United States
facility: Aventiv Research
state: Arizona
city: Mesa
country: United States
facility: Desert Clinical Research/ CCT Research
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: The Pain Center of Arizona
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute - Phoenix
state: Arizona
city: Phoenix
country: United States
facility: HOPE Research Institute
state: Arizona
city: Phoenix
country: United States
facility: Foothills Research Center/ CCT Research
state: Arizona
city: Surprise
country: United States
facility: Epic Medical Research - Surprise
state: Arizona
city: Tempe
country: United States
facility: Fiel Family and Sports Medicine, PC/CCT Research
state: Arizona
city: Tempe
country: United States
facility: HOPE Research Institute
state: Arizona
city: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Little Rock
country: United States
facility: Baptist Health Center For Clinical Research
state: Arkansas
city: Little Rock
country: United States
facility: Applied Research Center of Arkansas
state: Arkansas
city: Anaheim
country: United States
facility: Anaheim Clinical Trials
state: California
city: Banning
country: United States
facility: Velocity Clinical Research, San Bernardino
state: California
city: Colton
country: United States
facility: Benchmark Research
state: California
city: Fullerton
country: United States
facility: Ascada Health PC dba Ascada Research
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research
state: California
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research, San Diego
state: California
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Long Beach
country: United States
facility: Ark Clinical Research
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC
state: California
city: Pomona
country: United States
facility: Empire Clinical Research
state: California
city: Redding
country: United States
facility: Paradigm Clinical Research Centers, Inc
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: San Diego
country: United States
facility: Wr-McCr, Llc
state: California
city: San Diego
country: United States
facility: California Research Foundation
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Toluca Lake
country: United States
facility: Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
state: California
city: Torrance
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: Tustin
country: United States
facility: Ark Clinical Research - Tustin
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Fort Collins
country: United States
facility: Tekton Research, LLC.
state: Colorado
city: Longmont
country: United States
facility: Tekton Research, LLC.
state: Colorado
city: Wheat Ridge
country: United States
facility: Paradigm Clinical Research Centers, Inc
state: Colorado
city: Bridgeport
country: United States
facility: New England Research Associates, LLC
state: Connecticut
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: New Haven
country: United States
facility: New Haven Clinical Research Unit
state: Connecticut
city: New Haven
country: United States
facility: Yale Cardiology
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Stamford
country: United States
facility: Stamford Therapeutics Consortium
state: Connecticut
city: Washington
country: United States
facility: Washington Health Institute
state: District of Columbia
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Clearwater
country: United States
facility: Tampa Bay Medical Research
state: Florida
city: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Doral
country: United States
facility: Universal Axon Clinical Research, LLC
state: Florida
city: Fleming Island
country: United States
facility: Fleming Island Center for Clinical Research
state: Florida
city: Fort Lauderdale
country: United States
facility: Proactive Clinical Research,LLC
state: Florida
city: Fort Myers
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Fort Myers
country: United States
facility: Robert B. Pritt, DO
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research,Inc.
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Jupiter
country: United States
facility: Health Awareness
state: Florida
city: Lake City
country: United States
facility: Wr-Msra.Llc
state: Florida
city: Lake Worth
country: United States
facility: JEM Research Institute
state: Florida
city: Lakeland
country: United States
facility: Accel Research Sites Network - Lakeland Clinical Research Unit
state: Florida
city: Largo
country: United States
facility: Accel Research Sites - St. Petersburg Clinical Research Unit
state: Florida
city: Maitland
country: United States
facility: Accel Research Sites Network - Maitland Clinical Research Unit
state: Florida
city: Miami Lakes
country: United States
facility: Palm Springs Community Health Center
state: Florida
city: Miami
country: United States
facility: Care Research - West Flagler Street
state: Florida
city: Miami
country: United States
facility: Gerardo Polanco, MD
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Miami Dade Medical Research Institute, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando
state: Florida
city: Palmetto Bay
country: United States
facility: Innovation Medical Research Center
state: Florida
city: Pembroke Pines
country: United States
facility: DBC Research USA
state: Florida
city: Port Orange
country: United States
facility: United Medical Research
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Angels Clinical Research Institute
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Columbus
country: United States
facility: Centricity Research Columbus Georgia Multispecialty
state: Georgia
city: Rincon
country: United States
facility: IACT Health
state: Georgia
city: Rincon
country: United States
facility: Centricity Research Rincon Pulmonology
state: Georgia
city: Sandy Springs
country: United States
facility: AGILE Clinical Research Trials, LLC
state: Georgia
city: Sandy Springs
country: United States
facility: WR-Mount Vernon Clinical Research, LLC
state: Georgia
city: Savannah
country: United States
facility: CenExel iResearch, LLC
state: Georgia
city: Savannah
country: United States
facility: Javara - Privia Medical Group Georgia - Savannah
state: Georgia
city: Savannah
country: United States
facility: Velocity Clinical Research, Savannah
state: Georgia
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Idaho Falls
country: United States
facility: Clinical Research Prime
state: Idaho
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Morton
country: United States
facility: Koch Family Medicine
state: Illinois
city: Oak Lawn
country: United States
facility: Accellacare - DuPage
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research Center - Evansville - West Franklin Street
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center - EAST
state: Indiana
city: Valparaiso
country: United States
facility: Velocity Clinical Research, Valparaiso
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Sioux City
country: United States
facility: Velocity Clinical Research, Sioux City
state: Iowa
city: Newton
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Wichita
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kansas
city: Lexington
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Kentucky
city: Versailles
country: United States
facility: Versailles Family Medicine / CCT Research
state: Kentucky
city: Lafayette
country: United States
facility: MedPharmics, LLC
state: Louisiana
city: New Orleans
country: United States
facility: DelRicht Research
state: Louisiana
city: New Orleans
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Pharmaron
state: Maryland
city: Rockville
country: United States
facility: Advanced Primary and Geriatric Care - CCT Research
state: Maryland
city: Silver Spring
country: United States
facility: Jadestone Clinical Research
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices and Research
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Chan Medical School
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Grosse Pointe Woods
country: United States
facility: Ascension St. John Hospital
state: Michigan
city: Sterling Heights
country: United States
facility: Revival Research Institute, LLC
state: Michigan
city: Troy
country: United States
facility: Oakland Medical Research
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Chesterfield
country: United States
facility: Clinical Research Professionals
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Center for Vaccine Development
state: Missouri
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLD dba QPS-MO
state: Missouri
city: Springfield
country: United States
facility: QPS Bio-Kinetic Clinical Applications (Patient Screening Only)
state: Missouri
city: Bozeman
country: United States
facility: Bozeman Health Deaconess Hospital
state: Montana
city: Fremont
country: United States
facility: Methodist Physicians Clinic/CCT Research
state: Nebraska
city: Grand Island
country: United States
facility: Velocity Clinical Research, Grand Island
state: Nebraska
city: Lincoln
country: United States
facility: Be Well Clinical Studies
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research, Norfolk
state: Nebraska
city: Omaha
country: United States
facility: Quality Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Papillion
country: United States
facility: Papillion Research Center/CCT Research
state: Nebraska
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC
state: Nevada
city: Las Vegas
country: United States
facility: Santa Rosa Medical Centers of Nevada / CCT Research
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, LLC.
state: New Hampshire
city: Hackensack
country: United States
facility: David Jurist Research Building
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center Medical Plaza
state: New Jersey
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: Albuquerque
country: United States
facility: Albuquerque Clinical Trials, Inc.
state: New Mexico
city: Albuquerque
country: United States
facility: Velocity Clinical Research, Albuquerque
state: New Mexico
city: Horseheads
country: United States
facility: Smith Allergy & Asthma Specialists
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Vestal
country: United States
facility: Velocity Clinical Research, Vestal
state: New York
city: Cary
country: United States
facility: Accellacare - Cary
state: North Carolina
city: Charlotte
country: United States
facility: Accellacare - Charlotte
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences, LLC
state: North Carolina
city: Hickory
country: United States
facility: Accellacare - Hickory
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare - Raleigh
state: North Carolina
city: Raleigh
country: United States
facility: M3 Wake Research, Inc.
state: North Carolina
city: Rocky Mount
country: United States
facility: Accellacare - Rocky Mount
state: North Carolina
city: Salisbury
country: United States
facility: Accellacare - Salisbury
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Wilmington
country: United States
facility: Trial Management Associates - Wilmington - Floral Parkway
state: North Carolina
city: Winston-Salem
country: United States
facility: Accellacare - Winston-Salem
state: North Carolina
city: Fargo
country: United States
facility: Plains Clinical Research Center
state: North Dakota
city: Fargo
country: United States
facility: Plains Medical Clinic, LLC
state: North Dakota
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cincinnati
country: United States
facility: Meridian Clinical Research, LLC
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Senders Pediatrics
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research, Cleveland
state: Ohio
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Research
state: Ohio
city: Dayton
country: United States
facility: WellNow Urgent Care & Research
state: Ohio
city: Dayton
country: United States
facility: PriMED Clinical Research
state: Ohio
city: Edmond
country: United States
facility: Tekton Research, LLC.
state: Oklahoma
city: Moore
country: United States
facility: Tekton Research, LLC.
state: Oklahoma
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research, LLC.
state: Oklahoma
city: Medford
country: United States
facility: Velocity Clinical Research, Medford
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest Center for Health Research
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Erie
country: United States
facility: Central Erie Primary Care
state: Pennsylvania
city: East Greenwich
country: United States
facility: Velocity Clinical Research, Providence
state: Rhode Island
city: Anderson
country: United States
facility: Velocity Clinical Research, Anderson
state: South Carolina
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials
state: South Carolina
city: Columbia
country: United States
facility: Velocity Clinical Research, Columbia
state: South Carolina
city: Gaffney
country: United States
facility: Velocity Clinical Research, Gaffney
state: South Carolina
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Little River
country: United States
facility: Main Street Physician's Care
state: South Carolina
city: Moncks Corner
country: United States
facility: Clinical Trials of South Carolina
state: South Carolina
city: Myrtle Beach
country: United States
facility: Trial Management Associates
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Spartanburg
country: United States
facility: Velocity Clinical Research, Spartanburg
state: South Carolina
city: Union
country: United States
facility: Velocity Clinical Research, Union
state: South Carolina
city: Bristol
country: United States
facility: Internal Medicine and Pediatric Associates of Bristol
state: Tennessee
city: Chattanooga
country: United States
facility: WR-Clinsearch, LLC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
city: Knoxville
country: United States
facility: New Phase Research and Development
state: Tennessee
city: Knoxville
country: United States
facility: Accellacare US Inc., d/b/a Accellacare of Knoxville
state: Tennessee
city: Knoxville
country: United States
facility: Accellacare US Inc., d/b/a Accellacare of Knoxville
state: Tennessee
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Inc.
state: Tennessee
city: Austin
country: United States
facility: Elligo Clinical Research Center
state: Texas
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Tekton Research, LLC.
state: Texas
city: Austin
country: United States
facility: Orion Clinical Research
state: Texas
city: Austin
country: United States
facility: Velocity Clinical Research, Austin
state: Texas
city: Brownsville
country: United States
facility: Headlands Research - Brownsville
state: Texas
city: Dallas
country: United States
facility: WR-Global Medical Research, LLC
state: Texas
city: Dallas
country: United States
facility: DFW Clinical Research
state: Texas
city: Dallas
country: United States
facility: North Texas Infectious Diseases Consultants, P.A
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research - DeSoto
state: Texas
city: Edinburg
country: United States
facility: Proactive Clinical Research, LLC
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Fort Worth
country: United States
facility: Texas Health Family Care
state: Texas
city: Friendswood
country: United States
facility: Allure Health
state: Texas
city: Houston
country: United States
facility: Trio Clinical Trials
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Bellaire
state: Texas
city: Houston
country: United States
facility: Santa Clara Family Clinic
state: Texas
city: Humble
country: United States
facility: Dynamed Clinical Research, LP d/b/a DM Clinical Research
state: Texas
city: Laredo
country: United States
facility: Andres Garcia Zuniga, M.D., P.A.
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: Plano
country: United States
facility: AIM Trials, LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio
state: Texas
city: San Antonio
country: United States
facility: Tekton Research, LLC.
state: Texas
city: Stephenville
country: United States
facility: Javara - Privia Medical Group North Texas - Stephenville
state: Texas
city: Sugar Land
country: United States
facility: Sugar Lakes Family Practice, PA
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research, Martin Diagnostic Clinic
state: Texas
city: Tomball
country: United States
facility: Northwest Houston Heart Center
state: Texas
city: Victoria
country: United States
facility: Crossroads Clinical Research
state: Texas
city: Bountiful
country: United States
facility: Cope Family Medicine / CCT Research
state: Utah
city: Ogden
country: United States
facility: South Ogden Family Medicine/ CCT Research
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic
state: Utah
city: Salt Lake City
country: United States
facility: Olympus Family Medicine/CCT Research
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research, Inc. / Foothill Family Clinic South
state: Utah
city: South Jordan
country: United States
facility: J. Lewis Research, Inc. / Jordan River Family Medicine
state: Utah
city: Springville
country: United States
facility: Springville Dermatology - Springville/CCT Research
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City
state: Utah
city: Annandale
country: United States
facility: Clinical Alliance for Research and Education - Infectious Diseases (CARE-ID), LLC
state: Virginia
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Midlothian
country: United States
facility: Virginia Research Center
state: Virginia
city: Newport News
country: United States
facility: Health Research of Hampton Roads, Inc.
state: Virginia
city: Norfolk
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Virginia
city: Portsmouth
country: United States
facility: Meridian Clinical Research LLC
state: Virginia
city: Richmond
country: United States
facility: Clinical Research Partners, LLC
state: Virginia
city: Suffolk
country: United States
facility: Centricity Research Suffolk Primary Care
state: Virginia
city: Kirkland
country: United States
facility: EvergreenHealth Medical Center
state: Washington
city: Kirkland
country: United States
facility: EvergreenHealth
state: Washington
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute (KPWHRI)
state: Washington
city: Seattle
country: United States
facility: Kaiser Permanente Washington Health Research Institute
state: Washington
city: Seattle
country: United States
facility: Seattle Clinical Research Center
state: Washington
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists, LLC
state: Wisconsin
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos
state: Santa FE
city: San Miguel de Tucuman
country: Argentina
facility: Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L
state: Tucumán
city: Buenos Aires
country: Argentina
facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich
city: Santiago
country: Chile
facility: Enroll SpA
state: Región Metropolitana DE Santiago
city: Santiago
country: Chile
facility: Centro Skin Med Limitada
state: Región Metropolitana DE Santiago
city: Santiago
country: Chile
facility: CECIM
state: Región Metropolitana DE Santiago
city: Rotorua
country: New Zealand
facility: Pacific Clinical Research Network - Rotorua
state: BAY OF Plenty
city: Tauranga
country: New Zealand
facility: P3 Research - Tauranga
state: BAY OF Plenty
city: Christchurch
country: New Zealand
facility: Pacific Clinical Research Network - Forte
state: Canterbury
city: Hastings
country: New Zealand
facility: P3 Research - Hawke's Bay
state: Hawke's BAY
city: Hamilton
country: New Zealand
facility: Lakeland Clinical Trials Waikato
state: Waikato
city: Upper Hutt
country: New Zealand
facility: Lakeland Clinical Trials Wellington
state: Wellington
city: Auckland
country: New Zealand
facility: Southern Clinical Trials Totara
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials North
city: Auckland
country: New Zealand
facility: Optimal Clinical Trials
city: Nelson
country: New Zealand
facility: Southern Clinical Trials Tasman
city: Wellington
country: New Zealand
facility: P3 Research - Wellington
city: Iloilo City
country: Philippines
facility: West Visayas State University Medical Center
state: Iloilo
city: Mandaluyong
country: Philippines
facility: Health Cube Medical Clinics
state: Metro Manila
city: Makati
country: Philippines
facility: Tropical Disease Foundation
state: National Capital Region
city: Manila
country: Philippines
facility: Mary Johnston Hospital
state: National Capital Region
city: Quezon City
country: Philippines
facility: Lung Center of the Philippines
state: National Capital Region
city: Quezon City
country: Philippines
facility: Far Eastern University Nicanor Reyes Medical Foundation
state: National Capital Region
city: Puerto Princesa
country: Philippines
facility: Adventist Hospital Palawan
state: Palawan
city: Dasmarinas City
country: Philippines
facility: De La Salle Health Sciences Institute
city: Dasmarinas
country: Philippines
facility: De La Salle Medical and Health Sciences Institute
city: Iloilo City
country: Philippines
facility: St. Paul's Hospital of Iloilo, Inc.
city: Iloilo
country: Philippines
facility: Iloilo Doctors' Hospital
city: Manila
country: Philippines
facility: Philippine General Hospital
city: East London
country: South Africa
facility: Synergy Biomed Research Institute
state: Eastern CAPE
city: Port Elizabeth
country: South Africa
facility: Phoenix Pharma
state: Eastern CAPE
city: Bloemfontein
country: South Africa
facility: Iatros International
state: FREE State
city: Bloemfontein
country: South Africa
facility: Josha Research
state: FREE State
city: Benoni
country: South Africa
facility: Worthwhile Clinical Trials
state: Gauteng
city: Boksburg
country: South Africa
facility: REIMED Reiger Park
state: Gauteng
city: Johannesburg
country: South Africa
facility: Soweto Clinical Trials Centre
state: Gauteng
city: Kempton Park
country: South Africa
facility: Clinresco Centres
state: Gauteng
city: Krugersdorp
country: South Africa
facility: Ubuntu Clinical Research - Krugersdorp
state: Gauteng
city: Lenasia
country: South Africa
facility: Ubuntu Clinical Research - Lenasia
state: Gauteng
city: Moloto
country: South Africa
facility: Zinakekele Medicall Centre
state: Gauteng
city: Pretoria West
country: South Africa
facility: Jongaie Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Emmed Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Global Clinical Trials
state: Gauteng
city: Pretoria
country: South Africa
facility: Botho Ke Bontle Health Services
state: Gauteng
city: Soweto
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Tshwane
country: South Africa
facility: Setshaba Research Centre
state: Gauteng
city: Val De Grace
country: South Africa
facility: Synexus Watermeyer Clinical Research Centre
state: Gauteng
city: Vereeniging
country: South Africa
facility: FCRN Clinical Trial Centre
state: Gauteng
city: Chatsworth
country: South Africa
facility: Precise Clinical Solutions
state: Kwazulu-natal
city: Chatsworth
country: South Africa
facility: Private Practice - Dr. Peter Sebastian
state: Kwazulu-natal
city: Durban
country: South Africa
facility: Synapta Clinical Research Centre
state: Kwazulu-natal
city: Middelburg
country: South Africa
facility: MERCLINCO Middleburg
state: Mpumalanga
city: Rustenburg
country: South Africa
facility: Aurum Institute - Rustenburg
state: North-west
city: Cape Town
country: South Africa
facility: TREAD Research (Pty)Ltd
state: Western CAPE
city: Cape Town
country: South Africa
facility: TASK Applied Science
state: Western CAPE
city: Cape Town
country: South Africa
facility: Tiervlei Trial Centre
state: Western CAPE
city: Cape Town
country: South Africa
facility: TREAD Research
state: Western CAPE
city: uMzimkhulu
country: South Africa
facility: Umzimkhulu Research Centre
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: