Actively Recruiting
A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
Led by GlaxoSmithKline · Updated on 2026-03-27
225
Participants Needed
2
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who can comply with protocol requirements independently or with caregiver help
- Informed consent given before any study procedures
- Male or female aged 65 to 85 years at screening
- Healthy or medically stable based on medical history and examination
- Other protocol-defined inclusion criteria may apply
You will not qualify if you...
- Any clinically significant laboratory abnormality
- Confirmed symptomatic influenza infection within 180 days before vaccination
- Confirmed symptomatic COVID-19 infection within 90 days before vaccination
- History of Guillain-Barré syndrome within 6 weeks after any vaccine
- Current or past malignancy not resolved for more than 5 years, except treated basal cell carcinoma
- Confirmed or suspected immunosuppressive or immunodeficient condition
- History or suspicion of myocarditis or pericarditis or medical conditions increasing these risks
- History of allergic reactions to any component of study vaccines
- Acute or unstable chronic pulmonary, cardiovascular, or kidney problems
- Allergic reaction to previous influenza or COVID-19 vaccines
- Allergic reaction to previous mRNA vaccines
- Influenza vaccine within 181 days before or planned within 28 days after study vaccine
- COVID-19 vaccine within 91 days before or planned within 28 days after study vaccine
- mRNA vaccine within 29 days before or planned within 28 days after study vaccine
- Any other vaccine not in protocol within 29 days before or planned within 28 days after study vaccine
- Other protocol-defined exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
GSK Investigational Site
San Diego, California, United States, 92123
Actively Recruiting
2
GSK Investigational Site
Miami, Florida, United States, 33186
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
PREVENTION
Number of Arms
5
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