Seasonal InfluenzaPhase 1NCT07870330
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
A Phase 1 study testing mRNA-1010 and Fluarix Trivalent in people with Seasonal Influenza, run by ModernaTX, Inc. at 6 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 9 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- mRNA-1010 and Fluarix Trivalent
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 6 sitesUnited States
- Study dates
- 7 Oct 2026to 7 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites
Paradigm Clinical Research Centers, LLC
Aurora, Colorado, 80012
West Houston Clinical Research Service
Houston, Texas, 77055
Clinical Research Institute, Inc
Minneapolis, Minnesota, 55402
Paradigm Clinical Research Centers, LLC
Modesto, California, 95355
Clinical Research Partners, LLC.
Richmond, Virginia, 23226
Senders Pediatrics
South Euclid, Ohio, 44121
About this study
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)
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
- Being tested
- mRNA-1010, Fluarix Trivalent
- Keywords
- Flu, Influenza, Vaccine, mRNA vaccine, mRNA-1010, Moderna
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA-1010Biological
Also called Seasonal influenza vaccine
Suspension for injection
Fluarix TrivalentBiological
Also called A standard dose licensed inactivated seasonal influenza trivalent flu vaccine
Suspension for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1010 Low Dose | Experimental | Participants will receive a single low dose of mRNA-1010 by intramuscular (IM) injection on Day 1. Receives: Biological: mRNA-1010 |
| mRNA-1010 Full Dose | Experimental | Participants will receive a single full dose of mRNA-1010 by intramuscular (IM) injection on Day 1. Receives: Biological: mRNA-1010 |
| Fluarix Trivalent | Active comparator | Participants will receive a single dose of Fluarix Trivalent by IM injection on Day 1. Receives: Biological: Fluarix Trivalent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs)
Measured: Up to Day 7 (7 days after vaccination)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: 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)
Measured: Day 1 through Day 365
Number of Participants with Medically Attended AEs (MAAEs)
Measured: Day 1 through Day 181
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Measured: Day 29
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.
Measured: Day 29
Percentage of Participants With HAI Titer ≥ 1:40 at Day 29
Measured: Day 29
Geometric Mean Fold Rise (GMFR) of Anti-HA antibodies, as Measured by HAI Assays
Measured: Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start7 Oct 2026 (estimated)
- Primary completion7 Dec 2027 (estimated)
- Study completion7 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal InfluenzaStudies of the same condition, open and under way.
- More trials run by ModernaTX, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ModernaTX, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07870330
- Sponsor's protocol ID
- mRNA-1010-P102
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07870330
- Acronym / sponsor ID
- mRNA-1010-P102
- Conditions
- Seasonal Influenza
- Keywords
- Flu, Influenza, Vaccine, mRNA vaccine, mRNA-1010, Moderna
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- ModernaTX, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2026 (estimated)
- Primary completion
- 7 Dec 2027 (estimated)
- Study completion
- 7 Dec 2027 (estimated)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate safety, reactogenicity, and immunogenicity of mRNA-1010 in healthy children (9 to <18 years of age).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| mRNA-1010 Low Dose | Experimental | Biological: mRNA-1010Participants will receive a single low dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
| mRNA-1010 Full Dose | Experimental | Biological: mRNA-1010Participants will receive a single full dose of mRNA-1010 by intramuscular (IM) injection on Day 1. |
| Fluarix Trivalent | Active comparator | Biological: Fluarix TrivalentParticipants will receive a single dose of Fluarix Trivalent by IM injection on Day 1. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mRNA-1010Also: Seasonal influenza vaccineSuspension for injection | Biological | mRNA-1010 Full Dose, mRNA-1010 Low Dose |
| Fluarix TrivalentAlso: A standard dose licensed inactivated seasonal influenza trivalent flu vaccineSuspension for injection | Biological | Fluarix Trivalent |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing mRNA-1010 and Fluarix Trivalent in people with Seasonal Influenza, run by ModernaTX, Inc. at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Moderna WeCare Team (+1-866-663-3762, WeCareClinicalTrials@modernatx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.