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Not yet recruitingNCT07884175Updated Oct 20, 2026

A Study of Updated mRNA Seasonal Influenza Vaccines

A Phase 4 interventional study of mRNA-1010 and Licensed High-Dose Seasonal Influenza Vaccine in Seasonal Influenza, sponsored by ModernaTX, Inc.. Not yet recruiting. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.

Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Phase 4, Interventional, and Prevention

Updated Oct 20, 2026Newly registeredGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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 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.

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 200 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.

Browse ModernaTX, Inc. studies →All Moderna, Inc. studies →

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

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Key Inclusion Criteria:

  • 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.

Key Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    mRNA-1010 Influenza Strain-containing Composition (2026- 2027)

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

    Biological: mRNA-1010

  • Active comparator
    Licensed High-Dose Seasonal Influenza Vaccine

    Participants will receive a single dose of licensed high-dose seasonal influenza vaccine by IM injection on Day 1.

    Biological: Licensed High-Dose Seasonal Influenza Vaccine

Interventions

  • BiologicalmRNA-1010

    Sterile liquid for injection

  • BiologicalLicensed High-Dose Seasonal Influenza Vaccine

    Sterile liquid for injection

06

What researchers measure

Primary outcomes

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

    Time frame: Day 29

  2. 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.

    Time frame: Day 29

  3. Number of Participants with an HAI Titer ≥1:40 at Day 29

    Time frame: Day 29

  4. Geometric Mean Fold Rise (GMFR), as Measured by HAI Assay

    Time frame: Baseline to Day 29

Secondary outcomes

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

    Time frame: Day 1 through Day 29

  2. Number of Participants with Serious AEs, Medical-attended AEs and AE of Interest, and AEs Leading to Discontinuation

    Time frame: Day 1 through Day 29

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

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 2026, 1 month later.

Of 38 industry-sponsored phase 4 interventional studies under Influenza, Human, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 6. This study's planned 1 month is below that.

Counting every sponsor, half of 135 studies reached it within 14 months; a quarter within 3 and three quarters within 35.

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

Registered
Oct 13, 2026
First posted
Oct 20, 2026
StartEst.
Oct 15, 2026
Primary completionEst.
Dec 7, 2026
CompletionEst.
Dec 7, 2026
Last update
Oct 20, 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 20, 2026
Show all 1 update
  1. Oct 20, 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 ↗

10

Registry details

Key details

Study ID
NCT07884175
Lead sponsor
ModernaTX, Inc.
Responsible party
Sponsor
First posted
Oct 20, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Dec 7, 2026 (estimated)
Completion
Dec 7, 2026 (estimated)
Last update
Oct 20, 2026

Study contacts

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

Oversight

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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Discussion

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