Recruiting
Phase 4

mRNA-1010

Sponsor:

Moderna

Code:

NCT07884175

Conditions

Seasonal Influenza

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

Interventions

mRNA-1010

Licensed High-Dose Seasonal Influenza Vaccine

Study Details

Brief 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.

Conditions

Seasonal Influenza

Study ID

NCT07884175

Start date

Oct 15, 2026

Status verified date

Nov, 2026

Completion date

Dec 7, 2026

Anticipated

Primary completion date

Dec 7, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

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.

Interventions

mRNA-1010

Sterile liquid for injection

Licensed High-Dose Seasonal Influenza Vaccine

Sterile liquid for injection

Primary outcome measure

  • Geometric Mean Titer (GMT) of Anti-Hemagglutinin (HA) Antibodies at Day 29, as Measured by Hemagglutination Inhibition (HAI) Assay [ Time Frame: Day 29 ]
  • Number of Participants Reaching Seroconversion at Day 29 as Measured by HAI Assay [ Time Frame: Day 29 ]
  • Number of Participants with an HAI Titer ≥1:40 at Day 29 [ Time Frame: Day 29 ]
  • Geometric Mean Fold Rise (GMFR), as Measured by HAI Assay [ Time Frame: Baseline to Day 29 ]

Central Contacts and Locations

Central contacts

Moderna WeCare Team

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

Locations

Arizona Clinical Trials

Recruiting

Tucson, Arizona, United States, 85711

Johnson County Clin-Trials LLC (JCCT)

Recruiting

Lenexa, Kansas, United States, 66219

DelRicht Research at Derby City Direct Primary Care

Recruiting

Louisville, Kentucky, United States, 40205

DelRicht Research at Amy Roberts MD and Associates

Recruiting

Town and Country, Missouri, United States, 63017

More Information

Sponsor

ModernaTX, Inc.

Last update posted

Nov 13, 2026

Last verified

Nov, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-14. This information was provided to ClinicalTrials.gov by ModernaTX, Inc. on 2026-11-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.