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Not yet recruitingNCT07870330Updated Oct 13, 2026

A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children

A Phase 1 interventional study of mRNA-1010 and Fluarix Trivalent in Seasonal Influenza, sponsored by ModernaTX, Inc.. Not yet recruiting at 6 sites in United States. Open to participants aged 9 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-13.

Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Phase 1, Interventional, and Prevention

Updated Oct 13, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
96
Allocation
Randomized
Ages
9 Years to 17 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Seasonal Influenza

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Keywords

  • Flu
  • Influenza
  • Vaccine
  • mRNA vaccine
  • mRNA-1010
  • Moderna
03

In context

Influenza, Human

2,264 studies on the registry are indexed under Influenza, Human; 173 are open to participants now.

This study's planned enrollment of 96 is below the median of 240 across 1,894 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

ModernaTX, Inc. is the lead sponsor of 117 studies on the registry; 16 are open to participants now.

Of its 63 completed or terminated interventional studies of FDA-regulated products, 35 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.

05

Study design

Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
96 participants (estimated)

Study arms

  • Experimental
    mRNA-1010 Low Dose

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

    Biological: mRNA-1010

  • Experimental
    mRNA-1010 Full Dose

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

    Biological: mRNA-1010

  • Active comparator
    Fluarix Trivalent

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

    Biological: Fluarix Trivalent

Interventions

  • BiologicalmRNA-1010

    Suspension for injection

    Also known as: Seasonal influenza vaccine

  • BiologicalFluarix Trivalent

    Suspension for injection

    Also known as: A standard dose licensed inactivated seasonal influenza trivalent flu vaccine

06

What researchers measure

Primary outcomes

  1. Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)

    Time frame: Up to Day 7 (7 days after vaccination)

  2. Number of Participants with Unsolicited Adverse Events (AEs)

    Time frame: Up to Day 28 (28 days after vaccination)

  3. 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

  4. Number of Participants with Medically Attended AEs (MAAEs)

    Time frame: Day 1 through Day 181

  5. Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay

    Time frame: Day 29

  6. Percentage of Participants Reaching Seroconversion, as Measured by HAI Assay

    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.

    Time frame: Day 29

  7. Percentage of Participants With HAI Titer ≥ 1:40 at Day 29

    Time frame: Day 29

  8. Geometric Mean Fold Rise (GMFR) of Anti-HA antibodies, as Measured by HAI Assays

    Time frame: Day 29

07

Study locations

6 sites
  • Paradigm Clinical Research Centers, LLC
    Modesto, California 95355, United States
  • Paradigm Clinical Research Centers, LLC
    Aurora, Colorado 80012, United States
  • Clinical Research Institute, Inc
    Minneapolis, Minnesota 55402, United States
  • Senders Pediatrics
    South Euclid, Ohio 44121, United States
  • West Houston Clinical Research Service
    Houston, Texas 77055, United States
  • Clinical Research Partners, LLC.
    Richmond, Virginia 23226, United States
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

Of 84 industry-sponsored phase 1 interventional studies under Influenza, Human, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 16. This study's planned 14 months is above that.

Counting every sponsor, half of 139 studies reached it within 11 months; a quarter within 4 and three quarters within 21.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2026
First posted
Oct 13, 2026
StartEst.
Oct 7, 2026
Primary completionEst.
Dec 7, 2027
CompletionEst.
Dec 7, 2027
Last update
Oct 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 13, 2026
Show all 1 update
  1. Oct 13, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07870330
Lead sponsor
ModernaTX, Inc.
Responsible party
Sponsor
First posted
Oct 13, 2026
Start date
Oct 7, 2026 (estimated)
Primary completion
Dec 7, 2027 (estimated)
Completion
Dec 7, 2027 (estimated)
Last update
Oct 13, 2026

Study contacts

Moderna WeCare Team
Contact
WeCareClinicalTrials@modernatx.com
+1-866-663-3762

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: mRNA-1010 influenza vaccine

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