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

• ClinicalTrials.gov Identifier: NCT06237049
• Recruitment Status: Active, not recruiting
• First Posted: February 1, 2024
• Last Update Posted: March 26, 2024
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 30, 2024
• First Posted Date: February 1, 2024
• Last Update Posted Date: March 26, 2024
• Actual Study Start Date: January 31, 2024
• Estimated Primary Completion Date: September 5, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 30, 2024)

• Percentage of participants reporting local reactions [ Time Frame: For up to 7 days following vaccination ]
  Pain at the injection site, redness at the injection site, and swelling at the injection site
• Percentage of participants reporting systemic events [ Time Frame: For up to 7 days following vaccination ]
  Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain
• Percentage of participants reporting adverse events [ Time Frame: From the time the participant provides informed consent through 4 weeks after vaccination ]
  As elicited by investigational site staff
• Percentage of participants reporting serious adverse events [ Time Frame: From the time the participant provides informed consent through 6 months 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, Geometric Mean Titers (GMTs) of SARS-CoV-2 neutralizing titers [ Time Frame: 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, Geometric Mean Fold Rise (GMFR) in SARS-CoV-2 serum neutralizing titers [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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, GMFR in HAI titers from before vaccination to 4 weeks after vaccination [ Time Frame: 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 achieving HAI seroconversion [ Time Frame: 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 [ Time Frame: Before vaccination to 4 weeks after vaccination ]
  As measured at the central laboratory

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.

• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description:

Single-blind (site- and sponsor-unblinded)

Primary Purpose: Prevention

Condition

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

Intervention

• 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)

Study Arms

• Experimental: BNT162b2 (Omi XBB.1.5)/RIV and placebo
  Participants will receive a single injection combination of BNT162b2 (Omi XBB.1.5) and RIV and normal saline placebo
  Interventions:

  • Biological: BNT162b2 (Omi XBB.1.5)/RIV
  • Other: Normal saline placebo
• Experimental: BNT162b2 (Omi XBB.1.5) and RIV
  Participants will receive BNT162b2 (Omi XBB.1.5) and RIV
  Interventions:

  • Biological: BNT162b2 (Omi XBB.1.5)
  • Biological: RIV
• Active Comparator: BNT162b2 (Omi XBB.1.5) and placebo
  Participants will receive BNT162b2 (Omi XBB.1.5) and normal saline placebo
  Interventions:

  • Biological: BNT162b2 (Omi XBB.1.5)
  • Other: Normal saline placebo
• Active Comparator: RIV and placebo
  Participants will receive RIV and normal saline placebo
  Interventions:

  • Biological: RIV
  • Other: Normal saline placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: March 15, 2024): 595
• Original Estimated Enrollment (submitted: January 30, 2024): 640
• Estimated Study Completion Date: September 5, 2024
• Estimated Primary Completion Date: September 5, 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06237049
• Other Study ID Numbers: C5681001
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
• URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

• Current Responsible Party: Pfizer
• Original Responsible Party: Same as current
• Current Study Sponsor: Pfizer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2024