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Completed

NCT Number: NCT06602024

A Study of mRNA-1010 Compared With a Licensed Influenza Vaccine in Adults ≥50 Years of Age

The primary objectives of this study are to evaluate the safety and reactogenicity of mRNA-1010, and to evaluate relative vaccine efficacy (rVE) of mRNA-1010 versus an active comparator against reverse transcription polymerase chain reaction (RT-PCR)-confirmed protocol-defined influenza-like illness (ILI) caused by any influenza A or B strains.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anima Research Center, Alken, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Participants who are assigned female at birth or can become pregnant are eligible to participate if:
  • The participant is a person of nonchildbearing potential (PONCBP) or
  • The participant is a person of childbearing potential (POCBP) who:
  • Is not breast/chest feeding.
  • Is using an acceptable contraceptive method at least 28 days prior to Day 1 (Baseline) to at least 90 days after Day 1 (Baseline).
  • Has a negative highly sensitive pregnancy test (urine or serum as required by local regulation or institutional review board [IRB]/independent ethics committee [IEC]) at the Screening Visit and before study intervention (if the Day 1 [Baseline] Visit is not on the same day as the Screening Visit).

Exclusion criteria

  • Acutely ill or febrile (temperature ≥38.0 degrees Celsius (℃) [100.4° Fahrenheit [F]]) within 72 hours prior to Day 1 (Baseline).
  • Close contact with someone with laboratory-confirmed influenza infection or with someone who has been treated with antiviral therapies for influenza (for example, Tamiflu®/oseltamivir) within 5 days prior to Day 1 (Baseline).
  • History of a diagnosis or condition that, in the judgment of the Investigator, is clinically unstable or may affect participant safety, assessment of study endpoints, assessment of immune response, or adherence to study procedures.
  • Reported history of congenital or acquired immunodeficiency, immunosuppressive condition, asplenia, or recurrent severe infections disease.
  • Tested positive for influenza by local health authority-approved testing methods within 180 days prior to Day 1 (Baseline).
  • History of anaphylaxis or severe hypersensitivity reaction requiring medical intervention after receipt of any of the following: mRNA vaccine or therapeutic; components of an mRNA vaccine or therapeutic; influenza vaccine; or components of an influenza vaccine, including egg protein.
  • Malignancy within 2 years prior to Day 1 (Baseline) (adequately treated basal cell carcinoma and squamous cell carcinoma are allowed).
  • Received corticosteroids at ≥10 milligram (mg)/day of prednisone or equivalent for >14 days in total within 90 days prior to Day 1 (Baseline) or is anticipating the need for corticosteroids at any time during the study.
  • Received systemic immunosuppressive treatment, including long-acting biological therapies that affect immune responses (for example, infliximab), within 180 days prior to Day 1 (Baseline) or plans to do so during the study.
  • Treated with antiviral therapies for influenza (for example, Tamiflu) within 180 days prior to Day 1 (Baseline).
  • Received any 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 seasonal influenza vaccine within 180 days prior to Day 1 (Baseline) or plans to do so (outside of this study) at any time during the study.
  • Received an investigational seasonal influenza vaccine within 1 year prior to Day 1 (Baseline). Note: participants from mRNA-1010-P304 Season 1 are NOT eligible to re enroll into Season 2.
  • Participated in a clinical study with investigational treatment within 90 days prior to Day 1 (Baseline) based on the medical history interview or plans to do so while participating in this study.
  • Is working or has worked as study personnel or is an immediate family member or house member of study personnel, study staff, or Sponsor personnel.

Treatment and study plan

mRNA-1010

Biological

Intramuscular (IM) injection

Fluarix®

Biological

IM injection

Influsplit® Tetra

Biological

IM injection

Fluarix Tetra

Biological

IM injection

Alpharix® Tetra

Biological

IM injection

Primary outcomes

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

    Time frame: Day 1 to Day 7

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

    Time frame: Day 1 to Day 28

  3. Number of Participants with Medically Attended AEs (MAAEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), or Adverse Events of Special Interest (AESI)

    Time frame: Day 1 to Day 181

  4. Time to First Episode of RT-PCR Confirmed Protocol Defined ILI

    Time frame: Day 14 up to End of Season (up to approximately Day 181)

    ILI caused by any influenza A or B strains.

Secondary outcomes

  1. Number of Participants with First Episode of RT-PCR Confirmed Modified US Centers for Disease Control and Prevention (CDC)-Defined ILI

    Time frame: Day 14 up to End of Season (up to approximately Day 181)

    ILI caused by any influenza A or B strains.

  2. Number of Participants with First Episode of RT-PCR Confirmed Protocol-Defined ILI or Modified CDC-Defined ILI

    Time frame: Day 14 up to End of Season (up to approximately Day 181)

    ILI caused by influenza A or B strains with antigenic match to the vaccine strains.

  3. Geometric Mean Titer (GMT) of Hemagglutination Inhibition (HAI)

    Time frame: Day 29

    Humoral immunogenicity.

  4. Number of Participants Reaching Seroconversion as Measured by HAI

    Time frame: Day 29

  5. Number of Participants with an HAI Titer ≥1:40

    Time frame: Day 29

  6. Geometric Mean Fold Rise (GMFR) of HAI Titers

    Time frame: Day 1, Day 29

  7. HAI Titers

    Time frame: Day 29

    As measured by the HAI Assay.

  8. Number of Participants with First Episode of RT-PCR-Confirmed Protocol-Defined ILI

    Time frame: Day 14 up to End of Season (up to approximately Day 181)

    Correlates of Risk (CoR) and Correlates of Protection (CoP).

Sponsors and collaborators

Lead sponsor

ModernaTX, Inc.

Industry

Registry information

Official study title

A Phase 3, Randomized, Observer-blind, Active-controlled, Case-driven Study to Investigate the Safety, Efficacy, and Immunogenicity of mRNA-1010 Candidate Seasonal Influenza Vaccine Compared With a Licensed Inactivated Seasonal Influenza Vaccine in Adults ≥50 Years of Age

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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