Clinical trial NCT06237049: A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza, Human
SARS-CoV-2 Infection
COVID-19
Keywords: Grippe
Flu
Influenza Vaccine
RNA Vaccine
COVID-19
Coronavirus Vaccine
SARS-CoV-2
mRNA Vaccine
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 645
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical trial is to see if combining a licensed COVID-19 vaccine and a licensed influenza vaccine into a single shot is safe and can help produce antibodies to defend the body against both SARS-CoV-2 (the virus that causes COVID-19) and influenza. Participants enrolled in this trial will be healthy adults, 50 years of age or older.

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.

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.

Primary outcomes:
measure: Percentage of participants reporting local reactions
timeFrame: For up to 7 days following vaccination
measure: Percentage of participants reporting systemic events
timeFrame: For up to 7 days following vaccination
measure: Percentage of participants reporting adverse events
timeFrame: From the time the participant provides informed consent through 4 weeks after vaccination
measure: Percentage of participants reporting serious adverse events
timeFrame: From the time the participant provides informed consent through 6 months after vaccination
measure: In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, Geometric Mean Titers (GMTs) of SARS-CoV-2 neutralizing titers
timeFrame: Before vaccination and at 4 weeks after vaccination
measure: In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 serum neutralizing titers
timeFrame: Before vaccination to 4 weeks after vaccination
measure: In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, the percentage with seroresponse to SARS-CoV-2 Omicron (XBB.1.5)
timeFrame: 4 weeks after vaccination
measure: In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, GMTs of hemagglutination inhibition (HAI) titers
timeFrame: Before vaccination and at 4 weeks after vaccination
measure: In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, GMFR in HAI titers from before vaccination to 4 weeks after vaccination
timeFrame: Before vaccination to 4 weeks after vaccination
measure: In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, the percentage achieving HAI seroconversion
timeFrame: 4 weeks after vaccination
measure: In participants that received BNT162b2 (Omi XBB.1.5)/RIV, BNT162b2 (Omi XBB.1.5) + RIV coadministered or BNT162b2 (Omi XBB.1.5) and RIV alone, the proportion with HAI titers ≥1:40
timeFrame: Before vaccination to 4 weeks after vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Forest
country: United States
facility: Orange County Research Center
state: California
city: Tustin
country: United States
facility: Orange County Research Center
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Milford
country: United States
facility: Clinical Research Consulting
state: Connecticut
city: Washington
country: United States
facility: GW Medical Faculty Associates
state: District of Columbia
city: Washington
country: United States
facility: GW Vaccine Research Unit
state: District of Columbia
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Hialeah
country: United States
facility: Indago Research & Health Center, Inc
state: Florida
city: Melbourne
country: United States
facility: Optimal Research
state: Florida
city: Orlando
country: United States
facility: Headlands Research Orlando
state: Florida
city: Winter Park
country: United States
facility: Clinical Site Partners, LLC dba Flourish Research
state: Florida
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Peoria
country: United States
facility: Optimal Research
state: Illinois
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLC dba QPS-MO
state: Missouri
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications, LLD dba QPS-MO
state: Missouri
city: Springfield
country: United States
facility: Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center)
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: North Las Vegas
country: United States
facility: Las Vegas Clinical Trials
state: Nevada
city: Portsmouth
country: United States
facility: ActivMed Practices & Research, LLC.
state: New Hampshire
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Columbus
country: United States
facility: Centricity Research Columbus Ohio Multispecialty
state: Ohio
city: Nashville
country: United States
facility: Clinical Research Associates Inc
state: Tennessee
city: Houston
country: United States
facility: DM Clinical Research- Cyfair
state: Texas
city: Houston
country: United States
facility: DM Clinical Research - Bellaire
state: Texas
city: Mesquite
country: United States
facility: SMS Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Clinical Trials of Texas, LLC
state: Texas
city: San Antonio
country: United States
facility: IMA Clinical Research San Antonio
state: Texas
city: Tomball
country: United States
facility: DM Clinical Research - MDC
state: Texas
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: