NCT07464314

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Influenza, Human+COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Investigational 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.
BIOLOGICAL	Licensed Seasonal Influenza Vaccine	License Seasonal Influenza Vaccine will be administered as a single intramuscular dose.
BIOLOGICAL	Licensed COVID-19 Vaccine	Licensed COVID-19 Vaccine will be administered as a single intramuscular dose.

Timeline

• Start date: 2026-03-09
• Primary completion: 2026-12-03
• Completion: 2027-06-03
• First posted: 2026-03-11
• Last updated: 2026-03-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study