A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza

• ClinicalTrials.gov Identifier: NCT05596734
• Recruitment Status: Completed
• First Posted: October 27, 2022
• Last Update Posted: February 20, 2024
• Sponsor: BioNTech SE
• Collaborator: Pfizer
• Information provided by (Responsible Party): BioNTech SE

Study Description

Brief Summary:

Substudy A: This is a Phase 1 randomized, open-label study to describe the safety and immunogenicity of up to 3 dose- level combinations of modRNA quadrivalent influenza vaccine (qIRV (22/23)) and bivalent BNT162b2 (original/Omi BA.4/BA.5). Participants will receive either:

• qIRV (22/23)/bivalent BNT162b2 (original/Omi BA.4/BA.5), at 1 of the 3 dose-level combinations
• qIRV (22/23) at dose level 1,
• qIRV (22/23) at dose level 2, or
• bivalent BNT162b2 (original/Omi BA.4/BA.5) at dose level 1 administered concurrently in the opposite arm to commercially licensed quadrivalent influenza vaccine (QIV).

Substudy B: This Phase 1/2 study will describe the safety, tolerability, and immunogenicity of quadrivalent influenza vaccine (qIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), trivalent influenza vaccine (tIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5), and bivalent influenza vaccine (bIRV)/bivalent BNT162b2 (original/Omi BA.4/BA.5) when given concurrently with licensed quadrivalent influenza vaccine (QIV).

Condition or disease	Intervention/treatment	Phase
Influenza, Human; COVID-19	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Biological: qIRV (22/23); Biological: QIV; Biological: bIRV; Biological: tIRV	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1018 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)

Masking Description

Substudy A: Open-label unblinded.

Substudy B: Participants are blinded to their assigned study intervention.

• Primary Purpose: Prevention
• Official Title: A PHASE 1/2 STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF COMBINED MODIFIED RNA VACCINE CANDIDATES AGAINST COVID-19 AND INFLUENZA IN HEALTHY INDIVIDUALS
• Actual Study Start Date: October 28, 2022
• Actual Primary Completion Date: December 28, 2023
• Actual Study Completion Date: December 28, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: SSA: qIRV + bivalent BNT162b2 (dose level combination 1); Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSA: qIRV + bivalent BNT162b2 (dose level combination 2); Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSA: qIRV + bivalent BNT162b2 (dose level combination 3); Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSA: qIRV (dose level 1); Administered intramuscularly into the deltoid muscle of the right arm	Biological: qIRV (22/23); Intramuscular injection
Experimental: SSA: qIRV (dose level 2); Administered intramuscularly into the deltoid muscle of the right arm	Biological: qIRV (22/23); Intramuscular injection
Experimental: SSA: bivalent BNT162b2 (dose level 1) + QIV; BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSB: QIV + bivalent BNT162b2 (original/Omi BA.4/BA.5); BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: QIV; Intramuscular injection
Experimental: SSB: QIV + bIRV/bivalent BNT162b2 (original/Omi BA.4/BA.5); BNT162b2 administered intramuscularly into the deltoid muscle of the right arm, QIV administered intramuscularly into the deltoid muscle of the left arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: QIV; Intramuscular injection; Biological: bIRV; Intramuscular injection
Experimental: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 1; Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 2; Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 3; Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 4; Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 5; Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 6; Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 7; Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSB: qIRV/bivalent BNT162b2 (original/ Omi BA.4/BA.5) at dose-level combination 8; Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: qIRV (22/23); Intramuscular injection
Experimental: SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5); Administered intramuscularly into the deltoid muscle of the right arm	Biological: bivalent BNT162b2 (original/Omi BA.4/BA.5); Intramuscular injection; Biological: tIRV; Intramuscular injection
Experimental: SSB: qIRV; Administered intramuscularly into the deltoid muscle of the right arm	Biological: qIRV (22/23); Intramuscular injection

Outcome Measures

Primary Outcome Measures :

1. SSA: Percentage of participants reporting local reactions [ Time Frame: For 7 days after vaccination ]
   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 vaccination ]
   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: For 4 weeks after vaccination ]
   As elicited by investigational site staff.
4. SSA: Percentage of participants reporting serious adverse events [ Time Frame: For 6 months after vaccination ]
   As elicited by investigational site staff.
5. SSA: Percentage of participants with abnormal troponin I laboratory values [ Time Frame: 2 days after vaccination ]
   As measured at the central laboratory
6. SSA: Percentage of participants with abnormal troponin I laboratory values [ Time Frame: 1 week after vaccination ]
   As measured at the central laboratory
7. SSA: Percentage of participants with new electrocardiogram (ECG) abnormalities [ Time Frame: 2 days after vaccination ]
   ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
8. SSA: Percentage of participants with new ECG abnormalities [ Time Frame: 1 week after vaccination ]
   ECG abnormalities consistent with probable or possible myocarditis or pericarditis, as judged by a cardiologist
9. SSB Initial Enrollment: Percentage of participants with abnormal troponin I laboratory values [ Time Frame: 2 days after vaccination ]
   Measured at the central laboratory
10. SSB Initial Enrollment: Percentage of participants with abnormal troponin I laboratory values [ Time Frame: 1 week after vaccination ]
    As measured at the central laboratory
11. SSB Initial Enrollment: Percentage of participants with new electrocardiogram (ECG) abnormalities [ Time Frame: 2 days after vaccination ]
    ECG abnormalities consistent with probably or possible myocarditis or pericarditis as judged by a cardiologist
12. SSB Initial Enrollment: Percentage of participants with new electrocardiogram (ECG) abnormalities [ Time Frame: 1 week after vaccination ]
    ECG abnormalities consistent with probably or possible myocarditis or pericarditis as judged by a cardiologist
13. SSB: Percentage of participants reporting local reactions [ Time Frame: For 7 days after vaccination ]
    Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
14. SSB: Percentage of participants reporting systemic events [ Time Frame: For 7 days after vaccination ]
    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries.
15. SSB: Percentage of participants reporting adverse events [ Time Frame: For 4 weeks after vaccination ]
    As elicited by investigational site staff.
16. SSB: Percentage of participants reporting serious adverse events [ Time Frame: For 6 months after vaccination ]
    As elicited by investigational site staff.

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 ]
   As measured at the central laboratory
2. SSA: Geometric Mean Fold Rise (GMFRs) of HAI titers [ Time Frame: At baseline, and 1-, 4-, and 8-weeks after vaccination ]
   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 ]
   As measured at the central laboratory
4. SSA: Percentage of participants with HAI titers ≥ 1:40 for each strain [ Time Frame: Before vaccination and at 1-, 4-, 8-weeks after vaccination ]
   As measured at the central laboratory
5. SSA: Percentage of participants achieving HAI seroconversion for all strains [ Time Frame: At 1-, 4-, 8-weeks after vaccination ]
   As measured at the central laboratory
6. SSA: Percentage of participants with HAI ≥1:40 for all strains [ Time Frame: At 1-, 4-, 8-weeks after vaccination ]
   As measured at the central laboratory
7. SSA: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers [ Time Frame: At 1-, 4-, and 8 weeks after vaccination ]
   As measured at the central laboratory
8. SSA: GMFRs of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers [ Time Frame: At 1-, 4-, and 8 weeks after vaccination ]
   As measured at the central laboratory
9. SSA: Percentage of participants with seroresponse based on SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers [ Time Frame: At 1-, 4-, and 8 weeks after vaccination. ]
   As measured at the central laboratory
10. SSB: Geometric Mean Titers (GMTs) of hemagglutination inhibition (HAI) titers [ Time Frame: Initial: At baseline and 4 weeks after vaccination. Expanded: At baseline, 4 weeks and 6 months after vaccination ]
    As measured at the central laboratory
11. SSB: Geometric Mean Fold Rise (GMFRs) of HAI titers [ Time Frame: Initial: At baseline and 4 weeks after vaccination. Expanded: At baseline, 4 weeks and 6 months after vaccination ]
    As measured at the central laboratory
12. SSB: Proportion of participants achieving HAI seroconversion for each strain [ Time Frame: Initial: At baseline and 4 weeks after vaccination. Expanded: At baseline, 4 weeks and 6 months after vaccination ]
    As measured at the central laboratory
13. SSB: Percentage of participants with HAI titers ≥ 1:40 for each strain [ Time Frame: Initial: At baseline and 4 weeks after vaccination. Expanded: At baseline, 4 weeks and 6 months after vaccination ]
    As measured at the central laboratory
14. SSB: Percentage of participants achieving HAI seroconversion for all strains [ Time Frame: Initial: At baseline and 4 weeks after vaccination. Expanded: At baseline, 4 weeks and 6 months after vaccination ]
    As measured at the central laboratory
15. SSB: Percentage of participants with HAI ≥1:40 for all strains [ Time Frame: Initial: At baseline and 4 weeks after vaccination. Expanded: At baseline, 4 weeks and 6 months after vaccination ]
    As measured at the central laboratory
16. SSB: GMTs of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers [ Time Frame: Initial: At baseline and 4 weeks after vaccination. Expanded: At baseline, 4 weeks and 6 months after vaccination ]
    As measured at the central laboratory
17. SSB: GMFRs of SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers [ Time Frame: Initial: At baseline and 4 weeks after vaccination. Expanded: At baseline, 4 weeks and 6 months after vaccination ]
    As measured at the central laboratory
18. SSB: Percentage of participants with seroresponse based on SARS-CoV-2 Omicron (BA.4/BA.5)-neutralizing titers and SARS-CoV-2 reference-strain-neutralizing titers [ Time Frame: Initial: At baseline and 4 weeks after vaccination. Expanded: At baseline, 4 weeks and 6 months after vaccination ]
    As measured at the central laboratory

Eligibility Criteria

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

Criteria

SSA: Inclusion Criteria:

• Male or female participants 18 years of age and older
• Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
• Capable of giving signed informed consent as described in the protocol.
• For participants 18 through 64 years of age: participants who have received 3 prior doses of 30 µg BNT162b2, with the last dose being 150 to 365 days before Visit 1 (Day 1).
• For participants 65 years of age and older: participants who have received 4 or 5 prior doses of a modRNA SARS-CoV-2 vaccine, with the last dose being a bivalent vaccine, 120 days to 365 days before Visit 1 (Day 1).
• For Participants 65 years of age and older: receipt of licensed influenza vaccination for the 2022-2023 northern hemisphere season 120 days or more before study intervention administration.

SSA: Exclusion Criteria:

• History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Immunocompromised individuals with known or suspected immunodeficiency.
• Bleeding diathesis or condition associated with prolonged bleeding.
• Women who are pregnant or breastfeeding.
• Allergy to egg proteins (egg or egg products) or chicken proteins.
• 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.
• Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of the study.
• Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60 days before study intervention administration, or planned receipt throughout the study.
• For participants 18 through 64 years of age: vaccination with any investigational or licensed influenza vaccine within 6 months (175 days) before study intervention administration.
• Participation in other studies involving a study intervention within 28 days before randomization. Anticipated participation in other studies within 28 days after receipt of study intervention in this study.
• Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
• Participation in strenuous or endurance exercise through Visit 3 of the study.
• 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.

SSB: Inclusion Criteria

• Male or female participants 18 years of age and older
• Participants who are willing and able to comply with all scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures.
• Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
• Capable of giving signed informed consent as described in the protocol.
• Participants who have received at least 3 prior US-authorized mRNA COVID-19 vaccines, with the last dose being an updated (bivalent) vaccine given at least 150 days before Day 1.

SSB: Exclusion Criteria

• Medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• History of severe adverse reaction associated with any vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
• Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection
• Receipt of chronic systemic treatment with known immunosuppressant medications (including cytotoxic agents or systemic corticosteroids), or radiotherapy, within 60 days before enrollment through conclusion of 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 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
• Participation in other studies involving administration of a study intervention within 28 days prior to, and/or during, participation in this study.
• Investigator site staff directly involved in the conduct of the study and their family members, site staff otherwise supervised by the investigator, and sponsor and sponsor delegate employees directly involved in the conduct of the study and their family members.
• Initial enrollment only: Participation in strenuous or endurance exercise through Visit 3 (initial enrollment phase).
• Initial enrollment only: Prior history of heart disease of concern
• Initial enrollment only: 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

HOPE Research Institute

Phoenix, Arizona, United States, 85018

The Pain Center of Arizona

Phoenix, Arizona, United States, 85018

United States, California

Orange County Heart Institute

Orange, California, United States, 92868

California Research Foundation

San Diego, California, United States, 92123

Orange County Research Center

Tustin, California, United States, 92780

United States, Florida

Proactive Clinical Research,LLC

Fort Lauderdale, Florida, United States, 33308

Finlay Medical Research

Greenacres City, Florida, United States, 33467

Indago Research & Health Center, Inc

Hialeah, Florida, United States, 33012

Research Centers of America ( Hollywood )

Hollywood, Florida, United States, 33024

Palm Springs Community Health Center

Miami Lakes, Florida, United States, 33014

Panax Clinical Research

Miami Lakes, Florida, United States, 33014

Palm Springs Community Health Center

Miami Lakes, Florida, United States, 33016

Angels Clinical Research Institute

Miami, Florida, United States, 33122

Miami Clinical Research

Miami, Florida, United States, 33155

Gerardo 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

Innovation Medical Research Center

Palmetto Bay, Florida, United States, 33157

DBC Research USA

Pembroke Pines, Florida, United States, 33029

United Medical Research

Port Orange, Florida, United States, 32127

United States, Georgia

Velocity Clinical Research, Savannah

Savannah, Georgia, United States, 31406

Savannah Medical Group

Savannah, Georgia, United States, 31419

Clinical Research Atlanta

Stockbridge, Georgia, United States, 30281

United States, Hawaii

East-West Medical Research Institute

Honolulu, Hawaii, United States, 96814

United States, Illinois

Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States, 60640

Retina Associates

Elmhurst, Illinois, United States, 60126

Affinity Health

Oak Brook, Illinois, United States, 60523

Alliance for Multispecialty Research, LLC

Oak Brook, Illinois, United States, 60523

United States, Kansas

Alliance for Multispecialty Research, LLC

Wichita, Kansas, United States, 67207

United States, Maryland

Jadestone Clinical Research

Silver Spring, Maryland, United States, 20904

United States, Michigan

Michigan Center of Medical Research (MICHMER)

Farmington Hills, Michigan, United States, 48334

United States, Missouri

Pradeep Chandra, DO, FACC

Bridgeton, Missouri, United States, 63044

Clinical Research Professionals

Chesterfield, Missouri, United States, 63005

Sundance Clinical Research

Saint Louis, Missouri, United States, 63141

United States, Nebraska

Pioneer Heart Institute

Lincoln, Nebraska, United States, 68506

Quality Clinical Research

Omaha, Nebraska, United States, 68114

Velocity Clinical Research, Omaha

Omaha, Nebraska, United States, 68134

United States, New Hampshire

ActivMed Practices & Research, LLC.

Portsmouth, New Hampshire, United States, 03801

United States, New York

SUNY Upstate Medical University Institute for Global Health

Syracuse, New York, United States, 13215

United States, North Carolina

Monroe Biomedical Research

Monroe, North Carolina, United States, 28112

M3 Wake Research, Inc.

Raleigh, North Carolina, United States, 27612

United States, Ohio

CTI Clinical Research Center

Cincinnati, Ohio, United States, 45212

Centricity Research Columbus Ohio Multispecialty

Columbus, Ohio, United States, 43213

United States, Oklahoma

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States, 73112

United States, Rhode Island

Velocity Clinical Research, Providence

East Greenwich, Rhode Island, United States, 02818

United States, South Carolina

Main Street Physician's Care

Little River, South Carolina, United States, 29566

McLeod Cardiology Associates - Little River

Little River, South Carolina, United States, 29566

United States, Tennessee

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States, 37909

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States, 37920

United States, Texas

University of Texas Medical Branch

Galveston, Texas, United States, 77555

Prolato Clinical Research Center

Houston, Texas, United States, 77054

DM Clinical Research

Tomball, Texas, United States, 77375

United States, Virginia

Charlottesville Medical Research

Charlottesville, Virginia, United States, 22911

Sponsors and Collaborators

BioNTech SE

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: BioNTech SE
• ClinicalTrials.gov Identifier: NCT05596734
• Other Study ID Numbers: C5261001
• First Posted: October 27, 2022
• Last Update Posted: February 20, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by BioNTech SE:

SARS-Cov-2; COVID-19; Influenza; Grippe; Flu; Vaccine; RNA vaccine

Additional relevant MeSH terms:

COVID-19; Influenza, Human; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections