A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA Vaccine Against Influenza

• ClinicalTrials.gov Identifier: NCT05052697
• Recruitment Status: Completed
• First Posted: September 22, 2021
• Last Update Posted: March 6, 2023
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Influenza, Human	Biological: mIRV; Biological: bIRV AB; Biological: qIRV; Biological: QIV; Biological: bIRV AA; Biological: bIRV BB	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: SSA: observer-blinded, sponsor unblind SSB: single-blind, sponsor unblind
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: September 13, 2021
• Actual Primary Completion Date: January 27, 2023
• Actual Study Completion Date: January 27, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: SSA: mIRV A (dose level 1) + QIV	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: mIRV A (dose level 2) + QIV	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: mIRV A (dose level 3) + QIV	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: mIRV A (dose level 4) + QIV	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: mIRV B (dose level 1) + QIV	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: mIRV B (dose level 2) + QIV	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: mIRV B (dose level 3) + QIV	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: mIRV B (dose level 4) + QIV	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: bIRV AB (dose level combination 1) + QIV	Biological: bIRV AB; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: bIRV AB (dose level combination 2) + QIV	Biological: bIRV AB; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: bIRV AB (dose level combination 3) + QIV	Biological: bIRV AB; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: bIRV AB (dose level combination 4) + QIV	Biological: bIRV AB; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: QIV + mIRV A strain (dose level 4)	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: qIRV (dose level 1) + QIV	Biological: qIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSA: QIV + mIRV B strain (dose level 4)	Biological: mIRV; Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSB: 2 doses of qIRV (dose level 1), 2-visit schedule	Biological: qIRV; Intramuscular injection
Experimental: SSB: 2 doses of QIV, 2-visit schedule	Biological: QIV; Intramuscular injection
Experimental: SSB: QIV + bIRV AA (dose level combination 1), 2-visit schedule	Biological: QIV; Intramuscular injection; Biological: bIRV AA; Intramuscular injection
Experimental: SSB: QIV + bIRV AA (dose level combination 2), 2-visit schedule	Biological: QIV; Intramuscular injection; Biological: bIRV AA; Intramuscular injection
Experimental: SSB: QIV + bIRV AA (dose level combination 1), 1-visit schedule	Biological: QIV; Intramuscular injection; Biological: bIRV AA; Intramuscular injection
Experimental: SSB: QIV + bIRV AA (dose level combination 2), 1-visit schedule	Biological: QIV; Intramuscular injection; Biological: bIRV AA; Intramuscular injection
Experimental: SSB: qIRV (dose level 2, dose combination 1), 1-visit schedule; NOTE: Arm Description has not been entered.	Biological: qIRV; Intramuscular injection
Experimental: SSB: qIRV (dose level 2, dose combination 2), 1-visit schedule; NOTE: Arm Description has not been entered	Biological: qIRV; Intramuscular injection
Experimental: SSB: qIRV (dose level 3), 1-visit schedule; NOTE: Arm Description has not been entered	Biological: qIRV; Intramuscular injection
Experimental: SSB: bIRV AA + bIRV BB (both dose level combination 1), 1-visit schedule; NOTE: Arm Description has not been entered	Biological: bIRV AA; Intramuscular injection; Biological: bIRV BB; Intramuscular injection
Experimental: SSB: 1 dose of QIV, 1-visit schedule; NOTE: Arm Description has not been entered	Biological: QIV; Intramuscular injection
Experimental: SSB: qIRV (dose level 1), 1-visit schedule; NOTE: Arm Description has not been entered.	Biological: qIRV; Intramuscular injection
Experimental: SSB: qIRV (dose level 2), 1-visit schedule; NOTE: Arm Description has not been entered.	Biological: qIRV; Intramuscular injection

Outcome Measures

Primary Outcome Measures :

1. SSA: Percentage of participants reporting local reactions [ Time Frame: For 7 days after Vaccinations 1 and 2 ]
   Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
2. SSA: Percentage of participants reporting systemic events [ Time Frame: For 7 days after Vaccinations 1 and 2 ]
   Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries.
3. SSA: Percentage of participants reporting adverse events [ Time Frame: From vaccination to 4 weeks after Vaccinations 1 and 2 ]
   As elicited by investigational site staff.
4. SSA: Percentage of participants reporting serious adverse events [ Time Frame: From vaccination to 6 months after the last study vaccination ]
   As elicited by investigational site staff.
5. SSA: Percentage of participants with abnormal hematology and chemistry laboratory values [ Time Frame: 2 days after Vaccination 1 ]
   As measured at the central laboratory
6. SSA: Percentage of participants with abnormal hematology and chemistry laboratory values [ Time Frame: 1 week after Vaccination 1 ]
   As measured at the central laboratory
7. SSA: Percentage of participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 2 days after Vaccination 1 ]
   As measured at the central laboratory
8. SSA: Percentage of participants with grading shifts in hematology and chemistry laboratory assessments [ Time Frame: Between baseline and 1 week after Vaccination 1 ]
   As measured at the central laboratory
9. SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities [ Time Frame: 2 days after Vaccination 1 ]
   ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
10. SSA: Percentage of participants with new ECG abnormalities [ Time Frame: 1 week after Vaccination 1 ]
    ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
11. SSB: Percentage of participants reporting local reactions (18 to 64 and 65 to 85 years of age) [ Time Frame: For 7 days after each vaccination ]
    Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
12. SSB: Percentage of participants reporting systemic events (18 to 64 and 65 to 85 years of age) [ Time Frame: For 7 days after each vaccination ]
    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self reported in electronic diaries.
13. SSB: Percentage of participants reporting adverse events (18 to 64 and 65 to 85 years of age) [ Time Frame: From Vaccination 1 to 4 weeks after the last vaccination ]
    As elicited by investigational site staff.
14. SSB: Percentage of participants reporting serious adverse events (18 to 64 and 65 to 85 years of age) [ Time Frame: From Vaccination 1 to 6 months after the last vaccination ]
    As elicited by investigational site staff.
15. SSB: Percentage of participants with abnormal troponin I laboratory values (18 to 64 and 65 to 85 years of age) [ Time Frame: 2 days after the last vaccination ]
    As measured at the central laboratory
16. SSB: Percentage of participants with new ECG abnormalities (18 to 64 and 65 to 85 years of age) [ Time Frame: 2 days after the last vaccination ]
    ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist

Secondary Outcome Measures :

1. SSA: Geometric mean titers (GMTs) of hemagglutination inhibition (HAI) titers [ Time Frame: At Baseline, and 1-, 4- and 8-weeks after Vaccination 1 ]
   As measured at the central laboratory
2. SSA: Geometric mean fold rise (GMFR) in HAI titers from before vaccination to each subsequent timepoint [ Time Frame: At 1-, 4-, and 8-weeks after Vaccination 1 ]
   As measured at the central laboratory
3. SSA: Proportion of participants achieving HAI seroconversion for each strain [ Time Frame: At 1-, 4-, and 8-weeks after Vaccination 1 ]
   As measured at the central laboratory
4. SSA: Proportion of participants with HAI titer >=1:40 for each strain [ Time Frame: At Baseline, and 1-, 4-, and 8-weeks after Vaccination 1 ]
   As measured at the central laboratory.
5. SSA: In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants achieving HAI seroconversion for all strains [ Time Frame: At 1-, 4-, and 8-weeks after Vaccination 1 ]
   As measured at the central laboratory
6. SSA: In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants with HAI titer >=1:40 for all strains [ Time Frame: At Baseline, and 1-, 4-, and 8-weeks after Vaccination 1 ]
   As measured at the central laboratory.
7. SSA: The geometric mean ratio (GMR) of the geometric mean of HAI titers from participants receiving qIRV to the geometric mean of HAI titers from participants receiving QIV [ Time Frame: At 4 weeks after Vaccination 1 ]
   As measured at the central laboratory
8. SSA: The difference in percentage of participants achieving HAI seroconversion for each strain in qIRV recipients compared to licensed QIV recipients [ Time Frame: At 4 week after Vaccination 1 ]
   As measured at the central laboratory
9. SSB: GMTs of HAI titers (65-85 years of age) [ Time Frame: At Baseline, prior to Vaccination 2 (if applicable), and 1-, 4- and 8-weeks after the last vaccination ]
   As measured at the central laboratory
10. SSB: GMFR in HAI titers from before vaccination to each subsequent timepoint (65-85 years of age) [ Time Frame: Prior to Vaccination 2 (if applicable), and at 1-, 4-, and 8-weeks after the last vaccination ]
    As measured at the central laboratory
11. SSB: Proportion of participants achieving HAI seroconversion for each strain (65-85 years of age) [ Time Frame: Prior to Vaccination 2 (if applicable), and at 1-, 4-, and 8-weeks after the last vaccination ]
    As measured at the central laboratory
12. SSB: Proportion of participants with HAI titer >=1:40 for each strain (65-85 years of age) [ Time Frame: At Baseline, prior to Vaccination 2 (if applicable), and 1-, 4-, and 8-weeks after the last vaccination ]
    As measured at the central laboratory.
13. SSB: In participants who receive either qIRV or QIV, the proportion of participants achieving HAI seroconversion for all strains (65-85 years of age) [ Time Frame: Prior to Vaccination 2 (if applicable), and at 1-, 4-, and 8-weeks after the last vaccination ]
    As measured at the central laboratory
14. SSB: In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants with HAI titer >=1:40 for all strains (65-85 years of age) [ Time Frame: At Baseline, prior to Vaccination 2 (if applicable), and 1-, 4-, and 8-weeks after the last vaccination ]
    As measured at the central laboratory.
15. SSB: GMTs of HAI titers (18-64 years of age) [ Time Frame: At Baseline, prior to Vaccination and 1-, 4- and 8-weeks after vaccination ]
    As measured at the central laboratory
16. SSB: GMFR in HAI titers from before vaccination to each subsequent timepoint (18-64years of age) [ Time Frame: Prior to Vaccination, and at 1-, 4-, and 8-weeks after vaccination ]
    As measured at the central laboratory
17. SSB: Proportion of participants achieving HAI seroconversion for each strain (18-64 years of age) [ Time Frame: Prior to Vaccination, and at 1-, 4-, and 8-weeks after vaccination ]
    As measured at the central laboratory
18. SSB: Proportion of participants with HAI titer >=1:40 for each strain (18-64 years of age) [ Time Frame: At Baseline, prior to Vaccination, and 1-, 4-, and 8-weeks after vaccination ]
    As measured at the central laboratory.
19. SSB: In participants who receive either qIRV or QIV, the proportion of participants achieving HAI seroconversion for all strains (18-64 years of age) [ Time Frame: Prior to Vaccination, and at 1-, 4-, and 8-weeks after vaccination ]
    As measured at the central laboratory
20. SSB: In participants who receive either qIRV or QIV at Vaccination 1, the proportion of participants with HAI titer >=1:40 for all strains (18-64 years of age) [ Time Frame: At Baseline, prior to Vaccination, and 1-, 4-, and 8-weeks after vaccination ]
    As measured at the central laboratory.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Alabama

North Alabama Research Center

Athens, Alabama, United States, 35611

The Heart Center

Athens, Alabama, United States, 35611

United States, Arizona

Arizona Heart Rhythm Center

Phoenix, Arizona, United States, 85016

Hope Research Institute

Phoenix, Arizona, United States, 85018

The Pain Center of Arizona

Phoenix, Arizona, United States, 85018

Noble Clinical Research

Tucson, Arizona, United States, 85704

Pima Heart and Vascular

Tucson, Arizona, United States, 85704

United States, California

Inland Valley Cardiovascular Center

Murrieta, California, United States, 92563

Orange County Heart Institute

Orange, California, United States, 92868

Artemis Institute for Clinical Research

Riverside, California, United States, 92503

Orange County Research Center

Tustin, California, United States, 92780

United States, Colorado

Pediatrics-Infectious Diseases - Clinical Trials Center at University of Colorado Anschutz Medical C

Aurora, Colorado, United States, 80045

UCHealth Heart and Vascular Center - Anschutz Medical Campus

Aurora, Colorado, United States, 80045

United States, Connecticut

Yale University School of Medicine

New Haven, Connecticut, United States, 06510

Yale Cardiology

New Haven, Connecticut, United States, 06519

Yale University School of Medicine

New Haven, Connecticut, United States, 06519

United States, Florida

Alliance for Multispecialty Research, LLC

Coral Gables, Florida, United States, 33134

Halifax Health Medical Center

Daytona Beach, Florida, United States, 32114

NYU Langone Cardiology Associates

Delray Beach, Florida, United States, 33484

First Coast Heart & Vascular Center

Fleming Island, Florida, United States, 32003

Fleming Island Center for Clinical Research

Fleming Island, Florida, United States, 32003

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, United States, 33308

Alliance for Multispecialty Research, LLC

Fort Myers, Florida, United States, 33912

Millennium Physician Group

Fort Myers, Florida, United States, 33912

Robert B. Pritt, DO

Fort Myers, Florida, United States, 33912

Direct Helpers Research Center.

Hialeah, Florida, United States, 33012

Best Quality Research,Inc.

Hialeah, Florida, United States, 33016

Elixia Infectious Disease, LLC

Hollywood, Florida, United States, 33024

First Coast Heart & Vascular Center

Jacksonville, Florida, United States, 32216

Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

Jacksonville, Florida, United States, 32256

First Coast Cardiovascular Institute

Jacksonville, Florida, United States, 32256

Premier Cardiology and Vascular Associates

Maitland, Florida, United States, 32751

LMG Research

Miami, Florida, United States, 33125

Millennium Clinical Research

Miami, Florida, United States, 33125

Optimus U Corporation

Miami, Florida, United States, 33125

Suncoast Research Group

Miami, Florida, United States, 33135

Schiff Center for Liver Diseases/University of Miami

Miami, Florida, United States, 33136

University of Miami Hospital

Miami, Florida, United States, 33136

Dr Gerardo A. Polanco, MD

Miami, Florida, United States, 33156

Research Institute of South Florida

Miami, Florida, United States, 33173

Entrust Clinical Research

Miami, Florida, United States, 33176

Jackson Medical Group Cardiac Care

Miami, Florida, United States, 33176

Miami Dade Medical Research Institute, LLC

Miami, Florida, United States, 33176

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States, 32801

Central Florida Cardiology Group

Orlando, Florida, United States, 32803

Innovation Medical Research Center

Palmetto Bay, Florida, United States, 33157

DBC Research USA

Pembroke Pines, Florida, United States, 33029

Progressive Medical Research

Port Orange, Florida, United States, 32127

My Cardiologist

South Miami, Florida, United States, 33143

Precision Clinical Research

Sunrise, Florida, United States, 33351

Genesis Clinical Research, LLC

Tampa, Florida, United States, 33603

Conquest Research

Winter Park, Florida, United States, 32789

United States, Georgia

IACT Health

Columbus, Georgia, United States, 31904

IACT Health

Rincon, Georgia, United States, 31326

United States, Hawaii

East-West Medical Research Institute

Honolulu, Hawaii, United States, 96814

United States, Iowa

University of Iowa

Iowa City, Iowa, United States, 52242

United States, Kansas

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States, 67205

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States, 67207

Heartland Cardiology, LLC

Wichita, Kansas, United States, 67226

United States, Maryland

Centennial Medical Group

Elkridge, Maryland, United States, 21075

Associates of Cardiology

Silver Spring, Maryland, United States, 20910

United States, Michigan

Henry Ford Hospital

Detroit, Michigan, United States, 48202

United States, Nebraska

Pioneer Heart Institute

Lincoln, Nebraska, United States, 68506

Meridian Clinical Research, LLC

Norfolk, Nebraska, United States, 68701

Meridian Clinical Research - 3345 North 107th Street

Omaha, Nebraska, United States, 68134

Meridian Clinical Research, LLC

Omaha, Nebraska, United States, 68134

United States, Nevada

Sanjay Vohra, MD, F.A.C.C.

Henderson, Nevada, United States, 89074

Wr-Crcn, Llc.

Las Vegas, Nevada, United States, 89106

Excel Clinical Research, LLC

Las Vegas, Nevada, United States, 89109

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States, 89030

United States, New Jersey

Hassman Research Institute

Berlin, New Jersey, United States, 08009

Penn Medicine

Somers Point, New Jersey, United States, 08244

South Jersey Infectious Disease

Somers Point, New Jersey, United States, 08244

United States, New York

NYU Langone - Center for the Prevention of Cardiovascular Disease

New York, New York, United States, 10016

NYU Langone Health

New York, New York, United States, 10016

Rochester General Hospital Infectious Disease

Rochester, New York, United States, 14621

Rochester General Hospital

Rochester, New York, United States, 14621

University of Rochester Medical Center

Rochester, New York, United States, 14642

Upstate Health Care Center-University Cardiovascular Group of Syracuse

Syracuse, New York, United States, 13202

SUNY Upstate Medical University Global Health Research Unit

Syracuse, New York, United States, 13215

United States, North Carolina

M3-Emerging Medical Research, LLC

Durham, North Carolina, United States, 27704

Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States, 28303

Monroe Biomedical Research

Monroe, North Carolina, United States, 28112

United States, Ohio

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Aventiv Research Inc.

Columbus, Ohio, United States, 43213

Aventiv Research Inc

Columbus, Ohio, United States, 43213

Columbus Cardiovascular Associates, Inc

Columbus, Ohio, United States, 43213

United States, Pennsylvania

Pennsylvania Heart and Vascular Group

Jenkintown, Pennsylvania, United States, 19046

United States, South Carolina

Main Street Physician's Care

Little River, South Carolina, United States, 29566

United States, Texas

Prolato Clinical Research Center

Houston, Texas, United States, 77054

DM Clinical Research

Houston, Texas, United States, 77065

DM Clinical Research

Humble, Texas, United States, 77338

Cedar Health Research

Irving, Texas, United States, 75062

Harmony Heart Group

Plano, Texas, United States, 75093

Mt Olympus Medical Research

Sugar Land, Texas, United States, 77479

DM Clinical Research

Tomball, Texas, United States, 77375

Northwest Heart Center

Tomball, Texas, United States, 77375

United States, Virginia

Centricity Research Suffolk Primary Care

Suffolk, Virginia, United States, 23435

Sponsors and Collaborators

Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT05052697
• Other Study ID Numbers: C4781001
• First Posted: September 22, 2021
• Last Update Posted: March 6, 2023
• Last Verified: March 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:

Grippe; Flu; Influenza; Vaccine; RNA vaccine

Additional relevant MeSH terms:

Influenza, Human; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases