NCT07464314 · GlaxoSmithKline
A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
What this study 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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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
The assessed toxicity grades for laboratory value abnormalities will be defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Potentially life-threatening.
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Time frame: Day 1 to Day 8
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Time frame: Day 1 to Day 29
Number of Participants with Solicited Administration Site Adverse Events (AEs)
Time frame: Day 1 to Day 7
The solicited administration site AEs considered are pain, redness, swelling and lymphadenopathy.
Number of Participants with Solicited Systemic AEs
Time frame: Day 1 to Day 7
The solicited systemic AEs considered are fever, headache, fatigue, myalgia, arthralgia and chills.
Number of Participants with Unsolicited AEs
Time frame: Day 1 to Day 28
An unsolicited AE is an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events.
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Day 1 to Day 181
A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
Number of Participants with Adverse Events of Special Interest (AESIs)
Time frame: Day 1 to Day 181
The following events are considered as AESI in this study: severe hypersensitivity reactions within 24 hours after study intervention administration, Aminotransferase elevation; myocarditis/pericarditis within 6 weeks after study intervention administration and potential immune-mediated diseases (pIMDs).
Number of Participants with Medically Attended Adverse Events (MAAEs)
Time frame: Day 1 to Day 181
A MAAE is an AE for which the participant received medical attention including any symptom or illness requiring hospitalization, or an emergency room visit, or visit to/by a healthcare professional.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
- Informed consent obtained from the participant prior to performance of any study-specific procedure.
- A male or female 65 to 85 years of age (YoA) (inclusive) at the time of screening.
- Healthy participants or medically stable patients as established by medical history and clinical examination.
- Other protocol-defined inclusion criteria may apply.
Exclusion criteria
- Any clinically significant laboratory abnormality.
- 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.
- History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- 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.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
- Acute or unstable chronic conditions, clinically significant pulmonary, cardiovascular, or renal functional abnormality, as determined by physical examination and/or laboratory screening tests.
- History of hypersensitivity or allergic reaction to any previous influenza or COVID-19 vaccine.
- History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
- 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.
- 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.
- 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.
- 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.
- Other protocol-defined exclusion criteria may apply.
Where
- Anniston, Alabama
- Little Rock, Arkansas
- Fair Oaks, California
- San Diego, California
- Miami, Florida
- Miami Lakes, Florida
- West Palm Beach, Florida
- Stockbridge, Georgia
- Austin, Texas
- Charlottesville, Virginia
- Newport News, Virginia
- Seattle, Washington
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 30, 2026 · Source of record for eligibility and locations