A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combinati… (NCT07464314) | Clinical Trial Compass
RecruitingPhase 1
A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
United States225 participantsStarted 2026-03-09
Plain-language 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.
Who can participate
Age range65 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
✕. 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).
✕
What they're measuring
1
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities Following Administration of the Study Intervention
Timeframe: Day 1 to Day 3
2
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Timeframe: Day 1 to Day 8
3
Number of Participants with an Increase in Toxicity Grade of Laboratory Value Abnormalities following Administration of Study Intervention
Timeframe: Day 1 to Day 29
4
Number of Participants with Solicited Administration Site Adverse Events (AEs)
Timeframe: Day 1 to Day 7
5
Number of Participants with Solicited Systemic AEs
Timeframe: Day 1 to Day 7
6
Number of Participants with Unsolicited AEs
Timeframe: Day 1 to Day 28
7
Number of Participants with Serious Adverse Events (SAEs)
. 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.
Number of Participants with Adverse Events of Special Interest (AESIs)
Timeframe: Day 1 to Day 181
9
Number of Participants with Medically Attended Adverse Events (MAAEs)