A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults
- Conditions
- SARS-CoV-2 InfectionCOVID-19Influenza, Human
- Interventions
- Biological: BNT162b2 (Omi XBB.1.5)Biological: RIVBiological: BNT162b2 (Omi XBB.1.5)/RIVOther: Normal saline placebo
- Registration Number
- NCT06237049
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 645
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BNT162b2 (Omi XBB.1.5) and placebo Normal saline placebo Participants will receive BNT162b2 (Omi XBB.1.5) and normal saline placebo BNT162b2 (Omi XBB.1.5) and RIV BNT162b2 (Omi XBB.1.5) Participants will receive BNT162b2 (Omi XBB.1.5) and RIV RIV and placebo Normal saline placebo Participants will receive RIV and normal saline placebo RIV and placebo RIV Participants will receive RIV and normal saline placebo BNT162b2 (Omi XBB.1.5)/RIV and placebo Normal saline placebo Participants will receive a single injection combination of BNT162b2 (Omi XBB.1.5) and RIV and normal saline placebo BNT162b2 (Omi XBB.1.5)/RIV and placebo BNT162b2 (Omi XBB.1.5)/RIV Participants will receive a single injection combination of BNT162b2 (Omi XBB.1.5) and RIV and normal saline placebo BNT162b2 (Omi XBB.1.5) and RIV RIV Participants will receive BNT162b2 (Omi XBB.1.5) and RIV BNT162b2 (Omi XBB.1.5) and placebo BNT162b2 (Omi XBB.1.5) Participants will receive BNT162b2 (Omi XBB.1.5) and normal saline placebo
- Primary Outcome Measures
Name Time Method Percentage of participants reporting serious adverse events From the time the participant provides informed consent through 6 months after vaccination As elicited by investigational site staff
Percentage of participants reporting local reactions For up to 7 days following vaccination Pain at the injection site, redness at the injection site, and swelling at the injection site
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 Before vaccination to 4 weeks after vaccination As measured at the central laboratory
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) 4 weeks after vaccination As measured at the central laboratory
Percentage of participants reporting adverse events From the time the participant provides informed consent through 4 weeks after vaccination As elicited by investigational site staff
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 Before vaccination to 4 weeks after vaccination As measured at the central laboratory
Percentage of participants reporting systemic events For up to 7 days following vaccination Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain
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 Before vaccination and at 4 weeks after vaccination As measured at the central laboratory
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 Before vaccination and at 4 weeks after vaccination As measured at the central laboratory
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 4 weeks after vaccination As measured at the central laboratory
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 Before vaccination to 4 weeks after vaccination As measured at the central laboratory
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (27)
GW Vaccine Research Unit
🇺🇸Washington, District of Columbia, United States
Optimal Research
🇺🇸Peoria, Illinois, United States
GW Medical Faculty Associates
🇺🇸Washington, District of Columbia, United States
Headlands Research Orlando
🇺🇸Orlando, Florida, United States
Indago Research & Health Center, Inc
🇺🇸Hialeah, Florida, United States
SMS Clinical Research
🇺🇸Mesquite, Texas, United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
🇺🇸Springfield, Missouri, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
ActivMed Practices & Research, LLC.
🇺🇸Portsmouth, New Hampshire, United States
Clinical Site Partners, LLC dba Flourish Research
🇺🇸Winter Park, Florida, United States
DM Clinical Research- Cyfair
🇺🇸Houston, Texas, United States
Clinical Trials of Texas, LLC
🇺🇸San Antonio, Texas, United States
East-West Medical Research Institute
🇺🇸Honolulu, Hawaii, United States
Clinical Research Associates Inc
🇺🇸Nashville, Tennessee, United States
Las Vegas Clinical Trials
🇺🇸North Las Vegas, Nevada, United States
JEM Research Institute
🇺🇸Atlantis, Florida, United States
Clinical Research Consulting
🇺🇸Milford, Connecticut, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Centricity Research Columbus Ohio Multispecialty
🇺🇸Columbus, Ohio, United States
DM Clinical Research - Bellaire
🇺🇸Houston, Texas, United States
DM Clinical Research - MDC
🇺🇸Tomball, Texas, United States
IMA Clinical Research San Antonio
🇺🇸San Antonio, Texas, United States
Charlottesville Medical Research
🇺🇸Charlottesville, Virginia, United States
Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center)
🇺🇸Springfield, Missouri, United States
Orange County Research Center
🇺🇸Tustin, California, United States
Bio-Kinetic Clinical Applications, LLD dba QPS-MO
🇺🇸Springfield, Missouri, United States
Clinical Research Atlanta
🇺🇸Stockbridge, Georgia, United States