A Study to Learn About a Combined COVID-19 and Influenza Shot in Healthy Adults
NCT ID: NCT06237049
Last Updated: 2025-09-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
644 participants
INTERVENTIONAL
2024-01-31
2024-09-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Learn About How the Flu and COVID-19 Vaccines Act in Healthy People
NCT06821061
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Combined Modified RNA Vaccine Candidates Against COVID-19 and Influenza
NCT05596734
A Study to Learn About Flu and COVID-19 Vaccine Responses in Healthy People
NCT06683352
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Combined Modified RNA Vaccine Candidate Against COVID-19 and Influenza.
NCT06178991
A Study of mRNA-1083 (SARS-CoV-2 and Influenza) Vaccine in Healthy Adult Participants, ≥50 Years of Age
NCT06097273
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
BNT162b2 (Omi XBB.1.5)/RIV
Combination of BNT162b2 (Omi XBB.1.5) and RIV
Normal saline placebo
Normal saline (solution for injection)
BNT162b2 (Omi XBB.1.5) and RIV
Participants will receive BNT162b2 (Omi XBB.1.5) and RIV
BNT162b2 (Omi XBB.1.5)
Licensed COVID-19 vaccine
RIV
Licensed recombinant influenza vaccine
BNT162b2 (Omi XBB.1.5) and placebo
Participants will receive BNT162b2 (Omi XBB.1.5) and normal saline placebo
BNT162b2 (Omi XBB.1.5)
Licensed COVID-19 vaccine
Normal saline placebo
Normal saline (solution for injection)
RIV and placebo
Participants will receive RIV and normal saline placebo
RIV
Licensed recombinant influenza vaccine
Normal saline placebo
Normal saline (solution for injection)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Normal saline placebo
Normal saline (solution for injection)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pfizer
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Orange County Research Center
Lake Forest, California, United States
Orange County Research Center
Tustin, California, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Clinical Research Consulting
Milford, Connecticut, United States
GW Medical Faculty Associates
Washington D.C., District of Columbia, United States
GW Vaccine Research Unit
Washington D.C., District of Columbia, United States
JEM Research Institute
Atlantis, Florida, United States
Indago Research & Health Center, Inc
Hialeah, Florida, United States
Optimal Research
Melbourne, Florida, United States
Headlands Research Orlando
Orlando, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, United States
Clinical Research Atlanta
Stockbridge, Georgia, United States
East-West Medical Research Institute
Honolulu, Hawaii, United States
Optimal Research
Peoria, Illinois, 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
Bio-Kinetic Clinical Applications LLC DBA QPS-MO(Patient Screening Center)
Springfield, Missouri, United States
Las Vegas Clinical Trials
Las Vegas, Nevada, United States
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States
ActivMed Practices & Research, LLC.
Portsmouth, New Hampshire, United States
Rochester Clinical Research, LLC
Rochester, New York, United States
Centricity Research Columbus Ohio Multispecialty
Columbus, Ohio, United States
Clinical Research Associates Inc
Nashville, Tennessee, United States
DM Clinical Research- Cyfair
Houston, Texas, United States
DM Clinical Research - Bellaire
Houston, Texas, United States
SMS Clinical Research
Mesquite, Texas, United States
Clinical Trials of Texas, LLC
San Antonio, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
DM Clinical Research - MDC
Tomball, Texas, United States
Charlottesville Medical Research
Charlottesville, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
To obtain contact information for a study center near you, click here.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
C5681001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.