Clinical trial NCT05052697: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza
Official title: A PHASE 1/2 RANDOMIZED STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MODIFIED RNA VACCINE AGAINST INFLUENZA IN HEALTHY INDIVIDUALS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Influenza, Human
Keywords: Grippe
Flu
Influenza
Vaccine
RNA vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2021-09-22
Enrollment: 1158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will be divided into two substudies - Substudy A (SSA) and Substudy B (SSB)

Substudy A This is a Phase 1 randomized substudy to evaluate the safety and immunogenicity of monovalent influenza modRNA vaccine (mIRV) and bivalent influenza modRNA vaccine (bIRV) at various dose levels, and quadrivalent influenza modRNA vaccine (qIRV), in participants 65 to 85 years of age. Participants will receive at Vaccination 1 either:

* 1 of 4 dose levels of mIRV (either A or B Strain),
* 1 of 4 dose levels of bIRV (containing both A and B strains),
* qIRV (at 1 dose level), or
* A licensed quadrivalent influenza vaccine (QIV).

At approximately 8 weeks following Vaccination 1, participants will be unblinded and QIV (Vaccination 2) administered to participants not having previously received this at Vaccination 1. Additionally, participants who previously received QIV at Vaccination 1 will receive one of the following for Vaccination 2:

* mIRV encoding A strain at dose level 4, or
* mIRV encoding B strain at dose level 4.

Substudy B

This is a randomized substudy to evaluate the safety and immunogenicity of the following vaccination schedules in participants 65 to 85 years of age:

2-Visit Schedules

* 2 doses of qIRV (at a dose level 1), administered 21 days apart.
* 2 doses of licensed QIV, administered 21 days apart (as a control group)
* A dose of licensed QIV following by a dose of bIRV encoding 2 A strains at dose level combination 1 or 2, administered 21 days apart.

  1-Visit Schedules
* A dose of licensed QIV administered concurrently in the opposite arm with bIRV encoding 2 A strains at dose level combination 1 or 2.
* A dose of bIRV encoding 2 A strains administered concurrently in the opposite arm with a dose of bIRV encoding 2 B strains.at dose level 1.
* A dose of qIRV encoding 2 A strains and 2 B strains at dose level 2 (at one of two possible dose level combinations).
* A dose of qIRV encoding 2 A strains and 2 B strains at dose level 3.
* 1 dose of licensed QIV (as a control group).

Substudy B

In participants 18 to 64 years of age:

-A dose of qIRV encoding 2 A strains and 2 B strains at a dose level combination 1 or 2.


Eligibility criteria: Substudy A

Inclusion Criteria:

* Male or female participants 65 to 85 years of age.
* Participants who are willing and able to comply with all scheduled visits, treatment 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.
* Male participant who is able to father children and willing to use an acceptable method of contraception; or female participant not of childbearing potential; or male participant not able to father children.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Other 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 a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
* 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.
* Women who are pregnant or breastfeeding.
* Allergy to egg proteins (egg or egg products) or chicken proteins.
* Participant who has had significant exposure to laboratory-confirmed SARS-CoV-2 infection, COVID-19, or influenza in the past 14 days known prior to Visit 1
* Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 1 that has not been confirmed as negative.
* Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
* Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
* Vaccination with any influenza vaccine within 6 months (175 days) before study intervention administration.
* Any participant who has received or plans to receive a modRNA-platform SARS-CoV-2 vaccine within 60 days of Visit 1
* Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
* Screening hematology/blood chemistry lab \>=Grade 1 abnormality. Except Bilirubin, other stable Grade1 abnormalities may be considered eligible by Investigator.
* Screening ECG that is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or study results.
* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
* Participation in strenuous or endurance exercise through Visit 3.
* Prior history of heart disease.

Substudy B

Inclusion Criteria:

* Male or female participants 65 to 85 years of age or .Male or female participants 18 to 64 years of age
* Participants who are willing and able to comply with all scheduled visits, treatment 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.
* For participants 65 to 85 years of age at the time of enrollment, receipt of licensed influenza vaccination for the 2021-2022 northern hemisphere season \>4 months (120 days) before study intervention administration.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Other 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 a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention.
* 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.
* Women who are pregnant or breastfeeding.
* Allergy to egg proteins (egg or egg products) or chicken proteins.
* Participant who has had significant exposure to laboratory-confirmed SARS-CoV-2 infection, COVID-19, or influenza in the past 14 days known prior to Visit 201
* Any participant who has a SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to Visit 201 that has not been confirmed as negative.
* Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
* Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
* Any participant who has received or plans to receive a modRNA-platform SARS-CoV-2 vaccine within 28 days of Visit 201
* Any participant who has received licensed influenza vaccination for the 2022-2023 northern hemisphere influenza season.
* Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
* Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
* Participation in strenuous or endurance exercise through Visit 205.
* Prior history of heart disease.
* Any abnormal screening troponin I laboratory value
* Screening 12-lead ECG that, as judged by the investigator, is consistent with probable or possible myocarditis or pericarditis, or demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results.

Primary outcomes:
measure: Percentage of Participants Reporting Local Reactions After Vaccination 1: Substudy A
timeFrame: From Day 1 to Day 7 after Vaccination 1
measure: Percentage of Participants Reporting Local Reactions After Vaccination 2: Substudy A
timeFrame: From Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Systemic Events After Vaccination 1: Substudy A
timeFrame: From Day 1 to Day 7 After Vaccination 1
measure: Percentage of Participants Reporting Systemic Events After Vaccination 2: Substudy A
timeFrame: From Day 1 to Day 7 after Vaccination 2
measure: Percentage of Participants Reporting Adverse Events After Vaccination 1: Substudy A
timeFrame: From Day 1 up to 4 weeks After Vaccination 1
measure: Percentage of Participants Reporting Adverse Events After Vaccination 2: Substudy A
timeFrame: From Day 1 up to 4 weeks After vaccination 2
measure: Percentage of Participants Reporting Serious Adverse Events (SAE) From First Vaccination to 6 Months After Last Vaccination: Substudy A
timeFrame: From vaccination 1 on day 1 up to 6 months after vaccination 2
measure: Percentage of Participants With Abnormal Hematology Values at 2 Days After Vaccination 1: Substudy A
timeFrame: 2 days after vaccination 1
measure: Percentage of Participants With Abnormal Hematology Values at 1 Week After Vaccination 1: Substudy A
timeFrame: 1 week after vaccination 1
measure: Percentage of Participants With Abnormal Chemistry Values at 2 Days After Vaccination 1: Substudy A
timeFrame: 2 days after vaccination 1
measure: Percentage of Participants With Abnormal Chemistry Values at 1 Week After Vaccination 1: Substudy A
timeFrame: 1 week after vaccination 1
measure: Percentage of Participants With Grade Shifts in Hematology Values at 2 Days After Vaccination 1: Substudy A
timeFrame: From Baseline (prior to vaccination 1) to 2 days after vaccination 1
measure: Percentage of Participants With Grade Shifts in Hematology Values at 1 Week After Vaccination 1: Substudy A
timeFrame: From Baseline (prior to vaccination 1) to 1 week after vaccination 1
measure: Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 2 Days After Vaccination 1: Substudy A
timeFrame: From Baseline (prior to vaccination 1) to 2 days after vaccination 1
measure: Percentage of Participants With Grade Shifts in Chemistry Laboratory Values at 1 Week After Vaccination 1: Substudy A
timeFrame: From Baseline (prior to vaccination 1) to 1 week after vaccination 1
measure: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 2 Days After Vaccination 1: Substudy A
timeFrame: 2 days after vaccination 1
measure: Percentage of Participants With New Electrocardiogram (ECG) Abnormalities at 1 Week After Vaccination 1: Substudy A
timeFrame: 1 week after vaccination 1
measure: Percentage of Participants Reporting Local Reactions After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
timeFrame: From Day 1 to Day 7 after vaccination
measure: Percentage of Participants Reporting Local Reactions After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
timeFrame: From Day 1 to Day 7 after vaccination 1
measure: Percentage of Participants Reporting Local Reactions After Vaccination 2 for 2- Visit Schedule (Initial Enrollment): Substudy B
timeFrame: From Day 1 to Day 7 after vaccination 2
measure: Percentage of Participants Reporting Local Reactions After Vaccination for Expanded Enrollment: Substudy B
timeFrame: From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule arm
measure: Percentage of Participants Reporting Systemic Events After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
timeFrame: From Day 1 to Day 7 after vaccination
measure: Percentage of Participants Reporting Systemic Events After Vaccination 1 for 2- Visit Schedule (Initial Enrollment): Substudy B
timeFrame: From Day 1 to Day 7 after vaccination 1
measure: Percentage of Participants Reporting Systemic Events After Vaccination 2 for 2-Visit Schedule (Initial Enrollment) : Substudy B
timeFrame: From day 1 to day 7 of vaccination 2
measure: Percentage of Participants Reporting Systemic Events After Vaccination for Expanded Enrollment: Substudy B
timeFrame: From Day 1 to Day 7 after vaccination 1 for all arms; From Day 1 to Day 7 after vaccination 2 for 2 doses of qIRV (dose level 1), 2-visit schedule arm
measure: Percentage of Participants Reporting Adverse Events From First Vaccination Until 4 Weeks After Last Vaccination: Substudy B
timeFrame: From first vaccination to 4 weeks after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)
measure: Percentage of Participants Reporting Serious Adverse Events From First Vaccination Until 6 Months After Last Vaccination: Substudy B
timeFrame: From first vaccination to 6 month after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)
measure: Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B
timeFrame: 2 days after vaccination 1
measure: Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B
timeFrame: 2 days after vaccination 2
measure: Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for 1-Visit Schedule (Initial Enrollment): Substudy B
timeFrame: 2 days after vaccination
measure: Percentage of Participants Reporting Abnormal Troponin I Laboratory Values 2 Days After Vaccination for Expanded Enrollment: Substudy B
timeFrame: 2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)
measure: Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 2-Visit Schedule (Initial Enrollment): Substudy B
timeFrame: 2 days after vaccination 1
measure: Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 2 for 2-Visit Schedule (Initial Enrollment): Substudy B
timeFrame: 2 days after vaccination 2
measure: Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination 1 for 1-Visit Schedule (Initial Enrollment): Substudy B
timeFrame: 2 days after vaccination 1
measure: Percentage of Participants Reporting New ECG Abnormalities 2 Days After Vaccination for Expanded Enrollment: Substudy B
timeFrame: 2 days after last vaccination (i.e., Vaccination 1 for 1-visit schedule arms and Vaccination 2 for 2-visit schedule arms)
Secondary outcomes:
measure: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HAI) Titers at Weeks 1, 4 and 8 After Vaccination 1: Substudy A
timeFrame: Weeks 1, 4 and 8 after vaccination 1
measure: Geometric Mean Fold Rise (GMFR) in HAI Titers From Before Vaccination to 1, 4, and 8 Weeks After Vaccination 1: Substudy A
timeFrame: Before vaccination to 1, 4 and 8 weeks after vaccination 1
measure: Percentage of Participants Achieving HAI Seroconversion for Each Strain At 1, 4, and 8 Weeks After Vaccination 1: Substudy A
timeFrame: At 1, 4 and 8 Weeks after vaccination 1
measure: Percentage of Participants With HAI Titer >=1:40 for Each Strain Before Vaccination 1 and at 1, 4, and 8 Weeks After Vaccination 1: Substudy A
timeFrame: Before vaccination 1 on day 1 and 1, 4 and 8 weeks after vaccination 1
measure: Percentage of Participants Who Achieved HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
timeFrame: At 1, 4, and 8 weeks After vaccination 1
measure: Percentage of Participants With HAI Titers>=1:40 for All Strains Before Vaccination and at 1, 4, and 8 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
timeFrame: Before vaccination 1 on day 1 and 1, 4, and 8 weeks after vaccination 1
measure: Geometric Mean Ratio (GMR) of HAI Titers for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
timeFrame: 4 weeks After vaccination 1
measure: Difference in Percentage of Participants Achieving HAI Seroconversion for Each Strain at 4 Weeks After Vaccination 1: qIRV Versus Licensed QIV, Substudy A
timeFrame: 4 weeks after vaccination 1
measure: HAI GMTs Before Vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85): Expanded Enrollment: Substudy B
timeFrame: Before vaccination 1, 2 and, 1, 4, and 8 weeks after the last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms)
measure: HAI GMTs Before Vaccination 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years of Age): Initial Enrollment: Substudy B
timeFrame: Prior to vaccination 1 and 2, and at 1, 4, and 8 weeks after the last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms)
measure: HAI GMFR From Before Vaccination 2 to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
timeFrame: From before vaccination 2 to 1, 4, and 8 weeks after the last vaccination
measure: HAI GMFR From Before Vaccination 1 to Prior to Vaccination 2 and to 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
timeFrame: From before vaccination 1 to prior to vaccination 2, 1, 4, and 8 weeks after the last vaccination (i.e., vaccination 1 and 2 for 1-visit schedule and 2 visit schedule, respectively)
measure: Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
timeFrame: Prior to vaccination 2 and at 1, 4, and 8 Weeks After last Vaccination
measure: Percentage of Participants Achieving HAI Seroconversion for Each Strain Prior to Vaccination 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
timeFrame: Prior to vaccination 2 (2-visit arms only), 1, 4 and 8 weeks after last vaccination (i.e., vaccination 1 for 1 visit and vaccination 2 for 2 visit)
measure: Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
timeFrame: Before vaccination 1 and 2 and at 1, 4 and 8 weeks after last vaccination (i.e. after vaccination 1 for 1-vist schedule arms and after vaccination 2 for 2-visit schedule arms)
measure: Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccinations 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
timeFrame: Before vaccination 1 and 2 (for 2-visit only), and 1, 4 and 8 weeks after last vaccination (i.e., vaccination 1 for 1-visit arms and vaccination 2 for 2-visit arms)
measure: Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2, and at 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
timeFrame: Prior to vaccination 2 (for 2-visit schedule only) and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)
measure: Percentage of Participants Achieving HAI Seroconversion for All Strains Prior to Vaccination 2 and at 1, 4, and 8 Weeks the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
timeFrame: Prior to vaccination 2 (for 2-visit schedule only) and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)
measure: Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Expanded Enrollment: Substudy B
timeFrame: Prior to vaccination 1 and 2, and at 1, 4, and 8 weeks after last vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)
measure: Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccinations 1 and 2 and 1, 4, and 8 Weeks After the Last Vaccination (Participants Aged 65-85 Years): Initial Enrollment: Substudy B
timeFrame: Prior to vaccination 1 and 2 and at 1, 4, and 8 Weeks After the Last Vaccination (after vaccination 1 for 1-visit schedule and after vaccination 2 for 2-visit schedule)
measure: HAI GMTs Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
timeFrame: Before vaccination and 1, 4, and 8 Weeks After the Vaccination
measure: HAI GMFR From Before Vaccination to 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
timeFrame: Before vaccination to 1, 4, and 8 Weeks After Vaccination
measure: Percentage of Participants Achieving HAI Seroconversion for Each Strain at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
timeFrame: 1, 4, and 8 Weeks After Vaccination
measure: Percentage of Participants With HAI Titers >=1:40 for Each Strain Before Vaccination and at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
timeFrame: Before vaccination and 1, 4, and 8 Weeks After Vaccination
measure: Percentage of Participants Achieving HAI Seroconversion for All Strains at 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
timeFrame: 1, 4, and 8 Weeks After Vaccination
measure: Percentage of Participants With HAI Titers >=1:40 for All Strains Before Vaccination and 1, 4, and 8 Weeks After Vaccination (Participants Aged 18-64 Years): Substudy B
timeFrame: Before vaccination and 1, 4, and 8 Weeks After Vaccination
Other outcomes:
Locations:
city: Athens
country: United States
facility: North Alabama Research Center
state: Alabama
city: Athens
country: United States
facility: The Heart Center
state: Alabama
city: Phoenix
country: United States
facility: Arizona Heart Rhythm Center
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: Tucson
country: United States
facility: Noble Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: Murrieta
country: United States
facility: Inland Valley Cardiovascular Center
state: California
city: Orange
country: United States
facility: Orange County Heart Institute
state: California
city: Riverside
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Aurora
country: United States
facility: Pediatrics-Infectious Diseases - Clinical Trials Center at University of Colorado Anschutz Medical C
state: Colorado
city: Aurora
country: United States
facility: UCHealth Heart and Vascular Center - Anschutz Medical Campus
state: Colorado
city: New Haven
country: United States
facility: Yale University School of Medicine
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: Coral Gables
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Florida
city: Daytona Beach
country: United States
facility: Halifax Health Medical Center
state: Florida
city: Delray Beach
country: United States
facility: NYU Langone Cardiology Associates
state: Florida
city: Fleming Island
country: United States
facility: First Coast Heart & Vascular Center
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: Millennium Physician Group
state: Florida
city: Fort Myers
country: United States
facility: Robert B. Pritt, DO
state: Florida
city: Hialeah
country: United States
facility: Direct Helpers Research Center.
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research,Inc.
state: Florida
city: Hollywood
country: United States
facility: Elixia Infectious Disease, LLC
state: Florida
city: Jacksonville
country: United States
facility: First Coast Heart & Vascular Center
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. dba CNS Healthcare
state: Florida
city: Jacksonville
country: United States
facility: First Coast Cardiovascular Institute
state: Florida
city: Maitland
country: United States
facility: Premier Cardiology and Vascular Associates
state: Florida
city: Miami
country: United States
facility: LMG Research
state: Florida
city: Miami
country: United States
facility: Millennium Clinical Research
state: Florida
city: Miami
country: United States
facility: Optimus U Corporation
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases/University of Miami
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
city: Miami
country: United States
facility: Dr Gerardo A. Polanco, MD
state: Florida
city: Miami
country: United States
facility: Research Institute of South Florida
state: Florida
city: Miami
country: United States
facility: Entrust Clinical Research
state: Florida
city: Miami
country: United States
facility: Jackson Medical Group Cardiac Care
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: Central Florida Cardiology Group
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: Progressive Medical Research
state: Florida
city: South Miami
country: United States
facility: My Cardiologist
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Tampa
country: United States
facility: Genesis Clinical Research, LLC
state: Florida
city: Winter Park
country: United States
facility: Conquest Research
state: Florida
city: Columbus
country: United States
facility: Centricity Research Columbus Georgia Multispecialty
state: Georgia
city: Columbus
country: United States
facility: IACT Health
state: Georgia
city: Rincon
country: United States
facility: IACT Health
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
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: Wichita
country: United States
facility: Heartland Cardiology, LLC
state: Kansas
city: Elkridge
country: United States
facility: Centennial Medical Group
state: Maryland
city: Silver Spring
country: United States
facility: Associates of Cardiology
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Lincoln
country: United States
facility: Pioneer Heart Institute
state: Nebraska
city: Norfolk
country: United States
facility: Velocity Clinical Research, Norfolk
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research - 3345 North 107th Street
state: Nebraska
city: Omaha
country: United States
facility: Velocity Clinical Research, Omaha
state: Nebraska
city: Henderson
country: United States
facility: Sanjay Vohra, MD, F.A.C.C.
state: Nevada
city: Las Vegas
country: United States
facility: Wr-Crcn, Llc.
state: Nevada
city: Las Vegas
country: United States
facility: Excel Clinical Research, LLC
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Berlin
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Somers Point
country: United States
facility: Penn Medicine
state: New Jersey
city: Somers Point
country: United States
facility: South Jersey Infectious Disease
state: New Jersey
city: New York
country: United States
facility: NYU Langone - Center for the Prevention of Cardiovascular Disease
state: New York
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital Infectious Disease
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Syracuse
country: United States
facility: Upstate Health Care Center-University Cardiovascular Group of Syracuse
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Global Health Research Unit
state: New York
city: Durham
country: United States
facility: M3-Emerging Medical Research, LLC
state: North Carolina
city: Fayetteville
country: United States
facility: Carolina Institute for Clinical Research
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research Inc.
state: Ohio
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Columbus
country: United States
facility: Columbus Cardiovascular Associates, Inc
state: Ohio
city: Jenkintown
country: United States
facility: Pennsylvania Heart and Vascular Group
state: Pennsylvania
city: Little River
country: United States
facility: Main Street Physician's Care
state: South Carolina
city: Houston
country: United States
facility: Prolato Clinical Research Center
state: Texas
city: Houston
country: United States
facility: DM Clinical Research
state: Texas
city: Humble
country: United States
facility: DM Clinical Research
state: Texas
city: Irving
country: United States
facility: Cedar Health Research
state: Texas
city: Plano
country: United States
facility: Harmony Heart Group
state: Texas
city: Sugar Land
country: United States
facility: Mt Olympus Medical Research
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research
state: Texas
city: Tomball
country: United States
facility: Northwest Heart Center
state: Texas
city: Suffolk
country: United States
facility: Centricity Research Suffolk Primary Care
state: Virginia
city: Suffolk
country: United States
facility: Sentara BelleHarbour
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: