Seasonal InfluenzaPhase 4NCT07884175
A Study of Updated mRNA Seasonal Influenza Vaccines
A Phase 4 study testing mRNA-1010 and Licensed High-Dose Seasonal Influenza Vaccine in people with Seasonal Influenza, run by ModernaTX, Inc..
Trial summary
The purpose of this study is to evaluate the immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines within the current epidemiological environment. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- mRNA-1010 and Licensed High-Dose Seasonal Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 7 Dec 2026
- Phase
- Phase 4
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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
- Female participants must be of non-childbearing potential.
Who cannot join
- Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4° Fahrenheit [F]]) within 72 hours prior to at the Screening Visit or Day 1.
- 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
- History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable, potentially affects participant safety, could interfere with interpretation of study results or limit the participant's participation in the study.
- History of myocarditis, pericarditis, or myopericarditis within 90 days prior to Day 1 (Baseline).
- Received corticosteroids at ≥10 mg/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or within 28 days after Day 1.
- Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (eg, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
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- Tested positive for influenza by US Centers for Disease Control and Prevention (CDC)-recommended testing methods within 180 days prior to Day 1.
- Received systemic immunoglobulins or blood products within 90 days prior to Day 1 (Baseline) or plans to do so during the study.
- Received any vaccine (excluding seasonal influenza vaccine) authorized or approved by local health agency within 28 days prior to Day 1 (Baseline) or plans to do so within 14 days after Day 1 (Baseline).
- Received a licensed or investigational seasonal influenza vaccine within 6 months prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3b/4 Study to Assess the Immunogenicity and Safety of Updated mRNA Seasonal Influenza Vaccine Compositions
The purpose of this study is to evaluate the immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines within the current epidemiological environment.
Read the detailed description
This study uses a master protocol with a generic study design to allow flexibility in evaluating immunogenicity and safety of updated strain-containing compositions of the mRNA-1010 vaccines. As different strain-containing vaccine compositions will be evaluated, each study intervention will be described in the subprotocol. For each evaluation of an updated strain, a new subprotocol will be generated. Reported outcome measures are based upon each subprotocol. Not all reported outcome measures may be applicable to each subprotocol.
Subprotocol 01 is to evaluate the 2026-2027 mRNA influenza vaccine.
- Conditions
- Seasonal Influenza
- Being tested
- mRNA-1010, Licensed High-Dose Seasonal Influenza Vaccine
- 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
Sterile liquid for injection
Licensed High-Dose Seasonal Influenza VaccineBiological
Sterile liquid for injection
| Study group | Role | What they receive |
|---|---|---|
| mRNA-1010 Influenza Strain-containing Composition (2026- 2027) | Experimental | Participants will receive a single dose of mRNA-1010 by intramuscular (IM) injection on Day 1. Receives: Biological: mRNA-1010 |
| Licensed High-Dose Seasonal Influenza Vaccine | Active comparator | Participants will receive a single dose of licensed high-dose seasonal influenza vaccine by IM injection on Day 1. Receives: Biological: Licensed High-Dose Seasonal Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay
Measured: Day 29
Number of Participants Reaching Seroconversion at Day 29 as Measured by HAI Assay
Seroconversion is defined as a Day 29 titer ≥1:40 if baseline is <1:10 or a 4-fold or greater rise if baseline is ≥1:10 in anti-HA antibodies measured by HAI assay.
Measured: Day 29
Number of Participants with an HAI Titer ≥1:40 at Day 29
Measured: Day 29
Geometric Mean Fold Rise (GMFR), as Measured by HAI Assay
Measured: Baseline to Day 29
Secondary outcomes (2)
Number of Participants with Unsolicited Adverse Events (AEs)
Measured: Day 1 through Day 29
Number of Participants with Serious AEs, Medical-attended AEs and AE of Interest, and AEs Leading to Discontinuation
Measured: Day 1 through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion7 Dec 2026 (estimated)
- Study completion7 Dec 2026 (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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This master protocol is a Phase 3b/4 study. Subprotocol 1 is a Phase 4 study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 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
- NCT07884175
- Sponsor's protocol ID
- mRNA-1010-P401
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No