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Tests treatment safety and results for Influenza, Human+COVID-19
Official title A Study on the Safety and Immune Response of Investigational mRNA Seasonal Flu/COVID-19 Combination Vaccine in Adults
ClinicalTrials.gov ID: NCT07464314
What this study is testing
What is Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine?
Investigational mRNA Seasonal Flu/COVID-19 Combination (Flu/COVm) Vaccine is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for influenza, human+covid-19.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 85
You may be able to join if
- Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol independently or with the assistance...
- 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 may apply.
You likely can't join if
- 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)...
- 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...
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing...
- History of or current suspicion of myocarditis or pericarditis (including following administration of an mRNA vaccine); or idiopathic cardiomyopathy...
See the full eligibility 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 may apply.
- 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...
- 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...
- 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...
- 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 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)...
- Other protocol-defined exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- Anniston, Alabama, United States
- Little Rock, Arkansas, United States
- Fair Oaks, California, United States
- San Diego, California, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- West Palm Beach, Florida, United States
- Stockbridge, Georgia, United States
- Austin, Texas, United States
- Charlottesville, Virginia, United States
- Newport News, Virginia, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Anniston, Alabama, United States; Little Rock, Arkansas, United States; Fair Oaks, California, United States; San Diego, California, United States; Miami, Florida, United States; Miami Lakes, Florida, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.