mRNA combination vaccine for seasonal flu and COVID-19 in adults 65–85

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

This trial will test a new mRNA vaccine that combines protection against seasonal flu and COVID-19 in healthy adults aged 65 to 85.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 225 (estimated)
• Ages: 65 Years to 85 Years
• Sex: All
• Sponsor: GlaxoSmithKline (Industry-sponsored)
• Locations: 2 sites (San Diego, California and 1 other locations)
• Trial ID: NCT07464314 on ClinicalTrials.gov

What this trial studies

This Phase 1 interventional study will give healthy or medically stable adults aged 65–85 different doses of an investigational mRNA combination flu/COVID-19 vaccine or licensed comparator vaccines. Participants will be monitored for safety and side effects and will have blood samples taken at scheduled visits to measure immune responses against influenza and SARS‑CoV‑2. Some groups will receive a licensed seasonal influenza vaccine or a licensed COVID‑19 vaccine to provide comparison data. Follow-up visits will record adverse events, clinical exams, and laboratory results to characterize tolerability and preliminary immunogenicity.

Who should consider this trial

Good fit: Ideal candidates are healthy or medically stable adults aged 65–85 who can give informed consent and are able to comply with study procedures and visits.

Not a fit: People who recently had influenza or COVID‑19, have clinically significant lab abnormalities, a recent history of Guillain‑Barré syndrome, active unresolved cancer, or other exclusionary conditions are unlikely to be eligible or to receive benefit from this trial.

Why it matters

Potential benefit: If successful, this could offer older adults a single vaccine to protect against both seasonal flu and COVID‑19, potentially simplifying yearly vaccination.

How similar studies have performed: mRNA vaccines have been highly successful for COVID‑19, mRNA influenza vaccines remain experimental, and combining mRNA antigens into a single vaccine is a novel approach currently being tested in early-stage trials.

Eligibility criteria

Inclusion Criteria:

1. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance of the caregiver.
2. Informed consent obtained from the participant prior to performance of any study-specific procedure.
3. A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening.
4. Healthy participants or medically stable patients as established by medical history and clinical examination.
5. Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

1. Any clinically significant laboratory abnormality.
2. History of symptomatic influenza/ SARS-CoV-2 infection confirmed by local health authority-approved testing methods within 180 days (for influenza) or 90 days (SARS-CoV-2 infection) prior to study intervention administration.
3. History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
4. Current or past malignancy, unless completely resolved without clinically significant sequelae (e.g., no evidence of disease following successful treatment of basal cell carcinoma cases are allowed) for \>5 years.
5. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
6. History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy, or presence of any medical condition that increases the risk of myocarditis or pericarditis, including cocaine abuse, cardiomyopathy, endomyocardial fibrosis, hypereosinophilic syndrome, hypersensitivity myocarditis, eosinophilic granulomatosis with polyangiitis and persistent myocardial infection.
7. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
8. Acute or unstable chronic conditions, clinically significant pulmonary, cardiovascular, or renal functional abnormality, as determined by physical examination and/or laboratory screening tests.
9. History of hypersensitivity or allergic reaction to any previous influenza or COVID-19 vaccine.
10. History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
11. Administration of any influenza vaccine within 181 days before the study intervention administration (Day -180 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
12. Administration of a SARS-CoV-2 antigen-containing vaccine in the period starting 91 days before the study intervention administration (Day -90 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
13. Administration of any mRNA-based vaccine in the period starting 29 days before the study intervention administration (Day -28 to Day 1) or planned administration within 28 days (Day 29) after the study intervention administration.
14. Administration of any other vaccine not foreseen by the study protocol in the period starting 29 days (Day -28 to Day 1) before the study intervention administration or planned administration within 28 days (Day 29) after the study intervention administration.
15. Other protocol-defined exclusion criteria may apply.

Where this trial is running

San Diego, California and 1 other locations

• GSK Investigational Site — San Diego, California, United States (Recruiting)
• GSK Investigational Site — Miami, Florida, United States (Recruiting)

Study contacts

• Study coordinator: US GSK Clinical Trials Call Center

Conditions Influenza, Human+COVID-19; Influenza; COVID-19; SARS-CoV-2; mRNA vaccine; combination vaccine; immunogenicity; older adults