A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
NCT ID: NCT05596734
Last Updated: 2025-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
1019 participants
INTERVENTIONAL
2022-10-28
2023-12-28
Brief Summary
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* 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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Substudy B: Participants are blinded to their assigned study intervention.
Study Groups
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SSA: qIRV + bivalent BNT162b2 (dose level combination 1)
Administered intramuscularly into the deltoid muscle of the right arm
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
SSA: qIRV + bivalent BNT162b2 (dose level combination 2)
Administered intramuscularly into the deltoid muscle of the right arm
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
SSA: qIRV + bivalent BNT162b2 (dose level combination 3)
Administered intramuscularly into the deltoid muscle of the right arm
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
SSA: qIRV (dose level 1)
Administered intramuscularly into the deltoid muscle of the right arm
qIRV (22/23)
Intramuscular injection
SSA: qIRV (dose level 2)
Administered intramuscularly into the deltoid muscle of the right arm
qIRV (22/23)
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
QIV
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
QIV
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
QIV
Intramuscular injection
bIRV
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
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
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
SSB: tIRV/bivalent BNT162b2(original/Omi\BA.4/BA.5)
Administered intramuscularly into the deltoid muscle of the right arm
bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
tIRV
Intramuscular injection
SSB: qIRV
Administered intramuscularly into the deltoid muscle of the right arm
qIRV (22/23)
Intramuscular injection
Interventions
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bivalent BNT162b2 (original/Omi BA.4/BA.5)
Intramuscular injection
qIRV (22/23)
Intramuscular injection
QIV
Intramuscular injection
bIRV
Intramuscular injection
tIRV
Intramuscular injection
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
BioNTech SE
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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North Alabama Research Center
Athens, Alabama, United States
The Heart Center
Athens, Alabama, United States
HOPE Research Institute
Phoenix, Arizona, United States
The Pain Center of Arizona
Phoenix, Arizona, United States
Orange County Research Center
Lake Forest, California, United States
Orange County Heart Institute
Orange, California, United States
California Research Foundation
San Diego, California, United States
Orange County Research Center
Tustin, California, United States
Proactive Clinical Research,LLC
Fort Lauderdale, Florida, United States
Finlay Medical Research
Greenacres City, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Angels Clinical Research Institute
Miami, Florida, United States
Miami Clinical Research
Miami, Florida, United States
Gerardo Polanco, MD
Miami, Florida, United States
Research Institute of South Florida
Miami, Florida, United States
Entrust Clinical Research
Miami, Florida, United States
Jackson Medical Group Cardiac Care
Miami, Florida, United States
Miami Dade Medical Research Institute, LLC
Miami, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
Panax Clinical Research
Miami Lakes, Florida, United States
Palm Springs Community Health Center
Miami Lakes, Florida, United States
Innovation Medical Research Center
Palmetto Bay, Florida, United States
DBC Research USA
Pembroke Pines, Florida, United States
United Medical Research
Port Orange, Florida, United States
Velocity Clinical Research, Savannah
Savannah, Georgia, United States
Savannah Medical Group
Savannah, Georgia, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, United States
Retina Associates
Elmhurst, Illinois, United States
Affinity Health
Oak Brook, Illinois, United States
Alliance for Multispecialty Research, LLC
Oak Brook, Illinois, United States
Alliance for Multispecialty Research, LLC
Wichita, Kansas, United States
Jadestone Clinical Research
Silver Spring, Maryland, United States
Michigan Center of Medical Research (MICHMER)
Farmington Hills, Michigan, United States
Pradeep Chandra, DO, FACC
Bridgeton, Missouri, United States
Clinical Research Professionals
Chesterfield, Missouri, United States
Sundance Clinical Research
St Louis, Missouri, United States
Pioneer Heart Institute
Lincoln, Nebraska, United States
Quality Clinical Research
Omaha, Nebraska, United States
Velocity Clinical Research, Omaha
Omaha, Nebraska, United States
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, United States
SUNY Upstate Medical University Institute for Global Health
Syracuse, New York, United States
Monroe Biomedical Research
Monroe, North Carolina, United States
M3 Wake Research, Inc.
Raleigh, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Velocity Clinical Research, Providence
East Greenwich, Rhode Island, United States
Main Street Physician's Care
Little River, South Carolina, United States
McLeod Cardiology Associates - Little River
Little River, South Carolina, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
University of Texas Medical Branch
Galveston, Texas, United States
Prolato Clinical Research Center
Houston, Texas, United States
DM Clinical Research, Martin Diagnostic Clinic
Tomball, Texas, United States
DM Clinical Research
Tomball, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT05596734
Identifier Type: REGISTRY
Identifier Source: secondary_id
C5261001
Identifier Type: -
Identifier Source: org_study_id
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