Flu mRNA-1010 vaccine safety in children aged 9 to under 18
Official title: A Phase 1, Dose-escalation, Blinded Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children (9 to <18 Years of Age)
Run by ModernaTX, Inc. · NCT07870330 · Data updated 2026-11-12
This study tests the safety and immune response of the mRNA-1010 vaccine in healthy children ages 9 to under 18 who may receive a flu shot, alongside the standard Fluvarix Trivalent vaccine.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 9 Years to 17 Years |
| Sex | All |
| Enrollment | 96 (estimated) |
| Sponsor | ModernaTX, Inc. Industry-sponsored |
| Drugs / interventions | dupilumab, omalizumab, immunotherapy, methotrexate |
| Locations | 6 sites (Modesto, California and 5 other locations) |
| Status | Recruiting |
| Started | October 7, 2026 |
| Main results expected | December 7, 2027 |
| Study ends | December 7, 2027 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07870330 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 9 to under 18 who can understand and follow study procedures and have parental consent/assent, with appropriate contraception for females of childbearing potential as applicable.
✕Probably not a fit
Participants who do not mount an adequate immune response or who discontinue early may not receive a direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This early-phase trial examines how safe and tolerable the mRNA-1010 vaccine is in pediatric participants and whether it elicits an immune response. Participants receive mRNA-1010 with the option of Fluarix Trivalent, and are closely monitored for reactogenicity and safety outcomes. The study focuses on immunogenicity in a healthy pediatric population and follows standard safety procedures through the follow-up period. Enrollment is limited to children aged 9 to under 18 who meet the inclusion criteria and do not have contraindications to influenza vaccines.
Why it matters
Potential benefit: If successful, the vaccine could provide a safe and effective immune response against influenza in children.
How similar studies have gone: Previous studies with mRNA vaccines in adults have shown acceptable safety and immunogenicity, but pediatric data are limited and this represents an exploratory pediatric evaluation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion 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 comply with protocol mandated follow-up, including all procedures. * 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 to continue adequate contraception through 90 days following vaccine administration. Exclusion Criteria: * 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; or components of influenza vaccine, including egg protein. * 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. Participants who are acutely ill or febrile may be scheduled for a separate dosing visit within the window specified for Screening. * 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, the assessment of immune response, or adherence to study procedures. * Any prior systemic immunosuppressants, immunomodulators (for example, methotrexate, cyclosporine), or long-acting biological therapies that may affect immune responses (for example, dupilumab, omalizumab). Short courses (\<7 days) of oral corticosteroids are allowed if completed at least 3 months prior to Day 1. Inhaled, nasal, topical steroids, and subcutaneous injected allergy immunotherapy (allergy shots) are allowed. * 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 post study vaccine administration. * 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. Note: Other protocol-defined inclusion and exclusion criteria may apply.
Where it's running
-
Paradigm Clinical Research Centers, LLC
Modesto, California, United States Recruiting -
Paradigm Clinical Research Centers, LLC
Aurora, Colorado, United States Recruiting -
Clinical Research Institute, Inc
Minneapolis, Minnesota, United States Recruiting -
Senders Pediatrics
South Euclid, Ohio, United States Recruiting -
West Houston Clinical Research Service
Houston, Texas, United States Recruiting -
Clinical Research Partners, LLC.
Richmond, Virginia, United States Recruiting
Study contacts
- Study coordinator: Moderna WeCare Team
- Email: WeCareClinicalTrials@modernatx.com
- Phone: +1-866-663-3762
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Testing a new flu vaccine with and without an adjuvant in healthy adults
This study is testing a new flu vaccine with and without an added booster to see if it helps healthy adults aged 18 to 50 build a stronger immune response.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.