Seasonal Influenza study: MRNA-1010 vs Fluarix Trivalent
Official title A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
ClinicalTrials.gov ID: NCT07870330
What this study is testing
What is mRNA-1010?
This is an investigational injection being studied to help protect against seasonal flu. It is designed to teach your body to make a harmless part of the flu virus so your immune system can learn to recognize and fight it.
Also referred to as Seasonal influenza vaccine.
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 see how safe the vaccine is, what side reactions it causes, and how well it triggers an immune response.
- Who it's for
- Healthy children between 9 and 17 years old.
- What's involved
- Participants will receive the mRNA‑1010 vaccine and attend scheduled visits for health checks and blood tests.
- 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 9 to 17. Healthy volunteers may be eligible.
You may be able to join if
- 9 to \<18 years of age inclusive, at the time of signing the informed consent/assent.
- In the Investigator's opinion, the participants/participant's parent(s)/legally authorized representative (LAR(s)) demonstrate adequate understanding...
- For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could...
You likely can't join if
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any...
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4 degrees Fahrenheit [°F]) within 72 hours prior to or at the Screening Visit or...
- History of a diagnosis or condition not specifically listed as exclusionary that, in the judgment of the Investigator, is clinically unstable...
- Any prior systemic immunosuppressants, immunomodulators (for example, methotrexate, cyclosporine), or long-acting biological therapies that may...
- Received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.
- Received any nonstudy vaccine authorized or approved by local health agency within 14 days (28 days for live vaccines and mRNA vaccines) prior to Day...
See the full eligibility criteria
- 9 to \<18 years of age inclusive, at the time of signing the informed consent/assent.
- In the Investigator's opinion, the participants/participant's parent(s)/legally authorized representative (LAR(s)) demonstrate adequate understanding of the study requirements and are willing and physically able to...
- For female participants of childbearing potential: negative pregnancy test, adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to Day 1, and agreement...
- History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any mRNA vaccine or therapeutic or any components of an mRNA vaccine or therapeutic; influenza vaccine
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4 degrees Fahrenheit [°F]) within 72 hours prior to or at the Screening Visit or Day 1.
- History of a diagnosis or condition not specifically listed as exclusionary that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, the assessment of study endpoints...
- Any prior systemic immunosuppressants, immunomodulators (for example, methotrexate, cyclosporine), or long-acting biological therapies that may affect immune responses (for example, dupilumab, omalizumab).
- Received systemic immunoglobulins or blood products within 90 days prior to the Screening Visit or plans to receive them during the study.
- Received any nonstudy vaccine authorized or approved by local health agency within 14 days (28 days for live vaccines and mRNA vaccines) prior to Day 1 (inclusive) or plans to receive any nonstudy vaccine within 28 days...
- Donated ≥450 milliliters (mL) of blood products within 28 days prior to the Screening Visit or plans to donate blood products within 28 days post study vaccine administration.
The study team makes the final eligibility decision.
Where it is enrolling
- Modesto, California, United States
- Aurora, Colorado, United States
- Minneapolis, Minnesota, United States
- South Euclid, Ohio, United States
- Houston, Texas, United States
- Richmond, Virginia, 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 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, 9 years to 17 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 Modesto, California, United States; Aurora, Colorado, United States; Minneapolis, Minnesota, United States; South Euclid, Ohio, United States; Houston, Texas, United States; Richmond, Virginia, United States. 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.