A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults

COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06237049
• Other study ID #: C5681001
• Status: Active, not recruiting
• Phase: Phase 2
• 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
• 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.

Related Conditions & MeSH terms

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

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

External Links

•   To obtain contact information for a study center near you, click here.