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

Conditions

• Influenza, Human+COVID-19

Eligibility Criteria

Sex

ALL

Age

65 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine — 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 — BIOLOGICAL
  License Seasonal Influenza Vaccine will be administered as a single intramuscular dose.
• Licensed COVID-19 Vaccine — BIOLOGICAL
  Licensed COVID-19 Vaccine will be administered as a single intramuscular dose.

Study Details

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.

Key Dates

Start date

Mar 9, 2026

Status verified

Mar 2026

Primary completion

Dec 3, 2026

Completion

Jun 3, 2027

Study Design

Enrollment

225 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

PREVENTION

Arms

• Experimental: FLU/COVm_Dose Level 1
  Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 1 (Lowest dose).
• Experimental: FLU/COVm_Dose Level 2
  Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 2 (Medium dose).
• Experimental: FLU/COVm_Dose Level 3
  Participants receive a single intramuscular administration of the investigational mRNA Seasonal Flu/COVID-19 combination vaccine at dose level 3 (Highest dose).
• Active Comparator: Licensed Seasonal Influenza Vaccine Group
  Participants receive a single intramuscular administration of a licensed seasonal Flu vaccine.
• Active Comparator: Licensed COVID-19 Vaccine Group
  Participants receive a single intramuscular administration of a licensed COVID-19 vaccine.

Primary Outcome Measure

Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention [ Time Frame: Day 1 to Day 3 ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (2)

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