Official Title
A Phase 1/2 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Modified RNA COVID-19 Vaccine and a Recombinant Influenza Vaccine Administered as a Single Injection in Healthy Adults 50 Years of Age or Older
Brief Summary

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.

Detailed Description

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.

Completed
Influenza, Human
SARS-CoV-2 Infection
COVID-19

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)

Eligibility Criteria

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.

Eligibility Gender
All
Eligibility Age
Minimum: 50 Years ~ Maximum: N/A
Countries
United States
Locations

Orange County Research Center
Lake Forest 5364514, California 5332921, United States

Orange County Research Center
Tustin 5404119, California 5332921, United States

Diablo Clinical Research, Inc.
Walnut Creek 5406990, California 5332921, United States

Clinical Research Consulting
Milford 4838652, Connecticut 4831725, United States

GW Medical Faculty Associates
Washington D.C. 4140963, District of Columbia 4138106, United States

GW Vaccine Research Unit
Washington D.C. 4140963, District of Columbia 4138106, United States

JEM Research Institute
Atlantis 4146372, Florida 4155751, United States

Indago Research & Health Center, Inc
Hialeah 4158476, Florida 4155751, United States

Optimal Research
Melbourne 4163971, Florida 4155751, United States

Headlands Research Orlando
Orlando 4167147, Florida 4155751, United States

Clinical Site Partners, LLC dba Flourish Research
Winter Park 4178560, Florida 4155751, United States

Clinical Research Atlanta
Stockbridge 4224681, Georgia 4197000, United States

East-West Medical Research Institute
Honolulu 5856195, Hawaii 5855797, United States

Optimal Research
Peoria 4905687, Illinois 4896861, United States

Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield 4409896, Missouri 4398678, United States

Bio-Kinetic Clinical Applications, LLD dba QPS-MO
Springfield 4409896, Missouri 4398678, United States

Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center)
Springfield 4409896, Missouri 4398678, United States

Las Vegas Clinical Trials
Las Vegas 5506956, Nevada 5509151, United States

Las Vegas Clinical Trials
North Las Vegas 5509403, Nevada 5509151, United States

ActivMed Practices & Research, LLC.
Portsmouth 5091383, New Hampshire 5090174, United States

Rochester Clinical Research, LLC
Rochester 5134086, New York 5128638, United States

Centricity Research Columbus Ohio Multispecialty
Columbus 4509177, Ohio 5165418, United States

Clinical Research Associates Inc
Nashville 4644585, Tennessee 4662168, United States

DM Clinical Research- Cyfair
Houston 4699066, Texas 4736286, United States

DM Clinical Research - Bellaire
Houston 4699066, Texas 4736286, United States

SMS Clinical Research
Mesquite 4710826, Texas 4736286, United States

Clinical Trials of Texas, LLC
San Antonio 4726206, Texas 4736286, United States

IMA Clinical Research San Antonio
San Antonio 4726206, Texas 4736286, United States

DM Clinical Research - MDC
Tomball 4737094, Texas 4736286, United States

Charlottesville Medical Research
Charlottesville 4752031, Virginia 6254928, United States

Pfizer CT.gov Call Center, Study Director
Pfizer

NCT Number
Keywords
Grippe
Flu
Influenza Vaccine
RNA Vaccine
Covid-19
Coronavirus Vaccine
SARS-CoV-2
mRNA Vaccine
MeSH Terms
Influenza, Human
COVID-19
BNT162 Vaccine