NCT07870330 · ModernaTX, Inc.
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
What this study is about
The purpose of this study is to evaluate safety, reactogenicity, and immunogenicity of mRNA-1010 in healthy children (9 to \<18 years of age).
View original scientific description
The purpose of this study is to evaluate safety, reactogenicity, and immunogenicity of mRNA-1010 in healthy children (9 to \<18 years of age).
Interventions
BIOLOGICAL
mRNA-1010
Suspension for injection
BIOLOGICAL
Fluarix Trivalent
Suspension for injection
Primary outcome measures
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Time frame: Up to Day 7 (7 days after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Time frame: Up to Day 28 (28 days after vaccination)
Number of Participants with AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI)
Time frame: Day 1 through Day 365
Number of Participants with Medically Attended AEs (MAAEs)
Time frame: Day 1 through Day 181
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Time frame: Day 29
Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay
Time frame: Day 29
Seroconversion is defined as either a pre-vaccination HAI titer \<1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination HAI titer ≥1:10 and a minimum 4-fold rise in post-vaccination HAI antibody titer.
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29
Time frame: Day 29
Geometric Mean Fold Rise (GMFR) of Anti-HA antibodies, as Measured by HAI Assays
Time frame: Day 29
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Modesto, California
- Aurora, Colorado
- Minneapolis, Minnesota
- South Euclid, Ohio
- Houston, Texas
- Richmond, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 28, 2026 · Source of record for eligibility and locations