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Influenza, Human+COVID-19Immune and autoimmuneBiologicalPhase 1

What this study is

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.

What's being tested

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

    Intervention · BIOLOGICAL

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

  • Licensed Seasonal Influenza Vaccine

    Intervention · BIOLOGICAL

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

  • Licensed COVID-19 Vaccine

    Intervention · BIOLOGICAL

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

Study details

Official title
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
Conditions
Influenza, Human+COVID-19
Enrolling
1,475 people
Starts
2026-03-09
Est. completion
2027-06-03
Design
Triple-blind, randomized, sequential groups, Phase 1
Record
View on ClinicalTrials.gov ↗