RecruitingPhase 1NCT07464314

A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults

A Phase 1, Observer-Blind, Randomized, Controlled Study to Evaluate the Safety and Immunogenicity of an Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults


Sponsor

GlaxoSmithKline

Enrollment

225 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This early-stage study will look at a new mRNA vaccine that combines defenses against both seasonal flu and COVID-19 in terms of its safety and how it builds protection. Healthy adults aged 65 to 85 will receive different doses of this new vaccine, a standard flu vaccine, or COVID-19 vaccine. The study will assess any side effects or health issues, and additional blood samples will be collected at specific times to evaluate how well participants bodies build protection against the flu and COVID-19.


Eligibility

Min Age: 65 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine, a biological treatment called Licensed COVID-19 Vaccine, and others for people with influenza, human+covid-19. The study is currently recruiting participants at 2 locations. People eligible for this study include aged 65 Years to 85 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALInvestigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine

Flu/COVm Vaccine with multiple dose levels (Dose Level 1, Dose Level 2, and Dose Level 3), will be administered via single intramuscular injection.

BIOLOGICALLicensed Seasonal Influenza Vaccine

License Seasonal Influenza Vaccine will be administered as a single intramuscular dose.

BIOLOGICALLicensed COVID-19 Vaccine

Licensed COVID-19 Vaccine will be administered as a single intramuscular dose.


Locations(12)

GSK Investigational Site

Anniston, Alabama, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Fair Oaks, California, United States

GSK Investigational Site

San Diego, California, United States

GSK Investigational Site

Miami, Florida, United States

GSK Investigational Site

Miami Lakes, Florida, United States

GSK Investigational Site

West Palm Beach, Florida, United States

GSK Investigational Site

Stockbridge, Georgia, United States

GSK Investigational Site

Austin, Texas, United States

GSK Investigational Site

Charlottesville, Virginia, United States

GSK Investigational Site

Newport News, Virginia, United States

GSK Investigational Site

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT07464314