Influenza, Human study: MRNA Seasonal Flu vaccine vs Comparator
Official title A Study to Evaluate the Immune Response and Safety of a Vaccine Against Influenza in Adults 18-64 Years of Age
ClinicalTrials.gov ID: NCT07851246
What this study is testing
What is mRNA Seasonal Flu vaccine?
An investigational once‑dose intramuscular vaccine being studied for protection against seasonal influenza in adults. is designed to use messenger RNA to instruct cells to produce influenza proteins that stimulate an immune response.
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
- The study aims to learn how well the vaccine triggers an immune response against influenza and to identify any medical problems after vaccination.
- Who it's for
- Adults aged 18 to 64 years old.
- What's involved
- Participants will receive one injection into the upper arm muscle and will be monitored for about 6 months.
- Time commitment
- The study lasts about 6 months, with follow‑up visits during that period.
- Phase 3: a large, late-stage study
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64. Healthy volunteers may be eligible.
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 (e.g., completion of the eDiary...
- A male or female participant between and including 18 to 64 years of age at the time of study intervention administration
- has practiced adequate contraception for at least 30 days prior to study intervention administration, and
- has a negative urine pregnancy test within 24 hours prior to study intervention administration, and
- has agreed to continue adequate contraception for at least 8 weeks after study intervention administration.
You likely can't join if
- History of test confirmed influenza infection within 180 days prior to study intervention administration.
- Confirmed or suspected immunosuppressive or immunodeficient condition, except for stable human immunodeficiency virus infection meeting...
- History of myocarditis or pericarditis considered causally associated with the administration of an mRNA vaccine.
- History of hypersensitivity or allergic reaction to any previous influenza vaccine.
- History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
- History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
See the full eligibility criteria
- Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the eDiary, return for follow-up visits, attendance to study contacts, and ability to...
- A male or female participant between and including 18 to 64 years of age at the time of study intervention administration
- has practiced adequate contraception for at least 30 days prior to study intervention administration, and
- has a negative urine pregnancy test within 24 hours prior to study intervention administration, and
- has agreed to continue adequate contraception for at least 8 weeks after study intervention administration.
- History of test confirmed influenza infection within 180 days prior to study intervention administration.
- Confirmed or suspected immunosuppressive or immunodeficient condition, except for stable human immunodeficiency virus infection meeting protocol-defined stability criteria.
- History of myocarditis or pericarditis considered causally associated with the administration of an mRNA vaccine.
- History of hypersensitivity or allergic reaction to any previous influenza vaccine.
- History of hypersensitivity or allergic reaction to any previous mRNA vaccine.
- History of Guillain-Barré syndrome (GBS) within 6 weeks of receiving any vaccine.
- Acute or unstable chronic conditions as determined by medical history and clinical examination.
- Administration of an influenza vaccine in the period starting 180 days before the study intervention administration or planned administration prior to Visit 2 during the study.
- Planned administration/administration of prohibited vaccines within protocol-defined time windows before or after study intervention administration.
- Use of any investigational or non-registered product (other than the study intervention during the period beginning 30 days before the dose of study intervention (Day -29 to Day 1), or their planned use during the study...
- Chronic administration of immune-modifying drugs (defined as more than 14 consecutive days in total) and/or planned use of long-acting immune modifying treatments at any time up to the end of the study.
- Pregnant or lactating female participant.
The study team makes the final eligibility decision.
Where it is enrolling
- Glendale, Arizona, United States
- Tucson, Arizona, United States
- San Diego, California, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Meridian, Idaho, United States
- Valparaiso, Indiana, United States
- Lenexa, Kansas, United States
- Hartsdale, New York, United States
- Spartanburg, South Carolina, United States
- DeSoto, Texas, United States
- Fort Worth, Texas, 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, but confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Glendale, Arizona, United States; Tucson, Arizona, United States; San Diego, California, United States; Miami, Florida, United States; Miami Lakes, Florida, United States; Meridian, Idaho, United States and 6 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.