The purpose of this clinical trial is to see if combining a licensed COVID-19 vaccine anda licensed influenza vaccine into a single shot is safe and can help produce antibodiesto defend the body against both SARS-CoV-2 (the virus that causes COVID-19) andinfluenza. Participants enrolled in this trial will be healthy adults, 50 years of age orolder.
This is a Phase 1/2 study to evaluate the safety, tolerability, and immunogenicity of
licensed BNT162b2 (Omi XBB.1.5) and recombinant influenza vaccine (RIV) administered
together as a single injection (referred to as BNT162b2 [Omi XBB.1.5]/RIV) in healthy
adults 50 years of age or older.
The safety, tolerability, and immunogenicity of BNT162b2 (OmiXBB1.5)/RIV administered as
a single injection will be compared to BNT162b2 (Omi XBB.1.5) and RIV administered
simultaneously as 2 separate injections (coadministered), and to BNT162b2 (Omi XBB.1.5)
or RIV when administered alone.
Across Phases 1 and 2, approximately 640 participants in total will be randomized with an
equal randomization ratio to 1 of 4 vaccine groups and stratified by age.
Biological: BNT162b2 (Omi XBB.1.5)/RIV
Combination of BNT162b2 (Omi XBB.1.5) and RIV
Biological: BNT162b2 (Omi XBB.1.5)
Licensed COVID-19 vaccine
Biological: RIV
Licensed recombinant influenza vaccine
Other: Normal saline placebo
Normal saline (solution for injection)
Inclusion Criteria:
- Male or female participants aged 50 years or older at Visit 1 (Day 1).
- Participants who are willing and able to comply with all scheduled visits, the
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, which
includes compliance with the requirements and restrictions listed in the informed
consent document (ICD) and in the protocol.
Exclusion Criteria:
- Any 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.
- Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
hepatitis B virus (HBV).
- History of severe adverse reaction associated with any vaccine and/or severe
allergic reaction (eg, anaphylaxis) to any component of the study interventions.
- Participants with a history of autoimmune disease or an active autoimmune disease
requiring therapeutic intervention, including but not limited to systemic or
cutaneous lupus erythematosus, autoimmune arthritis/rheumatoid arthritis, multiple
sclerosis, Sjögren's syndrome, idiopathic thrombocytopenia purpura,
glomerulonephritis, autoimmune thyroiditis, temporal arteritis, psoriasis, and/or
insulin-dependent diabetes mellitus.
- Immunocompromised individuals with known or suspected immunodeficiency, determined
by history and/or laboratory/physical examination.
- Current heart disease, uncontrolled hypertension, or a prior history of myocarditis
or pericarditis.
- Bleeding diathesis or condition associated with prolonged bleeding that would, in
the opinion of the investigator, contraindicate intramuscular injection.
- Women who are pregnant, plan to become pregnant during the study, or are
breastfeeding.
- Prior history of ischemic stroke or transient ischemic attack.
- Prior history of Guillain-Barré syndrome (GBS).
- Participants with a calculated BMI of ≥35.
- Receipt of chronic medications with known systemic immunosuppressant effects
(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 used for
the treatment or prevention of COVID 19 or those that are considered
immunosuppressive, from 90 days before study intervention administration, or planned
receipt throughout the study.
- Vaccination with any investigational or licensed influenza vaccine within 6 months
(180 days) before study intervention administration, or ongoing receipt of chronic
antiviral therapy with activity against influenza.
- Vaccination with any investigational or licensed COVID-19 vaccine within 6 months
(180 days) before study intervention administration.
- Participation in other studies involving administration of an investigational
product 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.
- Deprived of freedom by an administrative or court order, or in an emergency setting,
or hospitalized involuntarily.
- Current alcohol abuse or drug addiction that in the opinion of the investigator
might interfere with the study conduct or completion.
Orange County Research Center
Lake Forest, California, United States
Orange County Research Center
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
GW Vaccine Research Unit
Washington D.C., District of Columbia, United States
JEM Research Institute
Atlantis, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Optimal Research
Melbourne, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Optimal Research
Peoria, Illinois, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications, LLD dba QPS-MO
Springfield, Missouri, United States
Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center)
Springfield, Missouri, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Clinical Research Associates Inc
Nashville, Tennessee, United States
DM Clinical Research- Cyfair
Houston, Texas, United States
DM Clinical Research - Bellaire
Houston, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
DM Clinical Research - MDC
Tomball, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Pfizer CT.gov Call Center, Study Director
Pfizer