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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06237049
Other study ID # C5681001
Secondary ID
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date January 31, 2024
Est. completion date September 5, 2024

Study information

Verified date March 2024
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 information / eligibility

Status Active, not recruiting
Enrollment 595
Est. completion date September 5, 2024
Est. primary completion date September 5, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
BNT162b2 (Omi XBB.1.5)/RIV
Combination of BNT162b2 (Omi XBB.1.5) and RIV
BNT162b2 (Omi XBB.1.5)
Licensed COVID-19 vaccine
RIV
Licensed recombinant influenza vaccine
Other:
Normal saline placebo
Normal saline (solution for injection)

Locations

Country Name City State
United States JEM Research Institute Atlantis Florida
United States Charlottesville Medical Research Charlottesville Virginia
United States Centricity Research Columbus Ohio Multispecialty Columbus Ohio
United States Indago Research & Health Center, Inc Hialeah Florida
United States East-West Medical Research Institute Honolulu Hawaii
United States DM Clinical Research - Bellaire Houston Texas
United States DM Clinical Research- Cyfair Houston Texas
United States Orange County Research Center Lake Forest California
United States Las Vegas Clinical Trials Las Vegas Nevada
United States Optimal Research Melbourne Florida
United States SMS Clinical Research Mesquite Texas
United States Clinical Research Consulting Milford Connecticut
United States Clinical Research Associates Inc Nashville Tennessee
United States Las Vegas Clinical Trials North Las Vegas Nevada
United States Headlands Research Orlando Orlando Florida
United States Optimal Research Peoria Illinois
United States ActivMed Practices & Research, LLC. Portsmouth New Hampshire
United States Rochester Clinical Research, LLC Rochester New York
United States Clinical Trials of Texas, LLC San Antonio Texas
United States IMA Clinical Research San Antonio San Antonio Texas
United States Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center) Springfield Missouri
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 Clinical Research Atlanta Stockbridge Georgia
United States DM Clinical Research Tomball Texas
United States Orange County Research Center Tustin California
United States Diablo Clinical Research, Inc. Walnut Creek California
United States GW Medical Faculty Associates Washington District of Columbia
United States GW Vaccine Research Unit Washington District of Columbia
United States Clinical Site Partners, LLC dba Flourish Research Winter Park Florida

Sponsors (1)

Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of participants reporting local reactions Pain at the injection site, redness at the injection site, and swelling at the injection site For up to 7 days following vaccination
Primary Percentage of participants reporting systemic events Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain For up to 7 days following vaccination
Primary Percentage of participants reporting adverse events As elicited by investigational site staff From the time the participant provides informed consent through 4 weeks after vaccination
Primary Percentage of participants reporting serious adverse events As elicited by investigational site staff From the time the participant provides informed consent through 6 months after vaccination
Primary 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 As measured at the central laboratory Before vaccination and at 4 weeks after vaccination
Primary 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 As measured at the central laboratory Before vaccination to 4 weeks after vaccination
Primary 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) As measured at the central laboratory 4 weeks after vaccination
Primary 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 As measured at the central laboratory Before vaccination and at 4 weeks after vaccination
Primary 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 As measured at the central laboratory Before vaccination to 4 weeks after vaccination
Primary 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 As measured at the central laboratory 4 weeks after vaccination
Primary 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 As measured at the central laboratory Before vaccination to 4 weeks after vaccination
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