Recruiting
Phase 1

mRNA-1010

Sponsor:

Moderna

Code:

NCT07870330

Conditions

Seasonal Influenza

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Accepted

Interventions

mRNA-1010

Fluarix Trivalent

Study Details

Brief summary:

The purpose of this study is to evaluate safety, reactogenicity, and immunogenicity of mRNA-1010 in healthy children (9 to <18 years of age).

Conditions

Seasonal Influenza

Study ID

NCT07870330

Start date

Oct 7, 2026

Status verified date

Oct, 2026

Completion date

Dec 7, 2027

Anticipated

Primary completion date

Dec 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 9 - 17

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

96 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: mRNA-1010 Low Dose

Participants will receive a single low dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

experimental: mRNA-1010 Full Dose

Participants will receive a single full dose of mRNA-1010 by intramuscular (IM) injection on Day 1.

active comparator: Fluarix Trivalent

Participants will receive a single dose of Fluarix Trivalent by IM injection on Day 1.

Interventions

mRNA-1010

Suspension for injection

Fluarix Trivalent

Suspension for injection

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Moderna WeCare Team

+1-866-663-3762WeCareClinicalTrials@modernatx.com

Locations

Paradigm Clinical Research Centers, LLC

Recruiting

Modesto, California, United States, 95355

Clinical Research Institute, Inc

Recruiting

Minneapolis, Minnesota, United States, 55402

Senders Pediatrics

Recruiting

South Euclid, Ohio, United States, 44121

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Oct 28, 2026

Last verified

Oct, 2026

Keywords

  • Flu
  • Influenza
  • Vaccine
  • mRNA vaccine
  • mRNA-1010
  • Moderna

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-29. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-10-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.