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Study of mRNA-1010 Influenza Vaccine Compared to Standard Flu Vaccine in Adults 50 Years and Older

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on testing a new influenza vaccine called mRNA-1010 in comparison with an already approved flu vaccine. The study aims to determine how safe and effective the new vaccine is in protecting adults aged 50 and older against the flu. The new vaccine uses messenger RNA technology, which is different from traditional flu vaccines.

During the study, participants will receive either the new mRNA-1010 vaccine or a standard licensed influenza vaccine called Influsplit Tetra through an intramuscular injection. Both vaccines are designed to protect against different strains of influenza viruses. The study will monitor participants for any side effects and track how well the vaccines prevent flu-like illness caused by influenza viruses.

The research team will collect information about vaccine reactions in the first week after vaccination, track any unexpected health issues for 28 days, and continue monitoring participants' health for approximately 6 months. They will also measure how well the body's immune system responds to the vaccines by checking blood samples and documenting any cases of flu-like illness that occur during the study period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and eligibility check

    A pregnancy test will be performed if you are capable of becoming pregnant

    Your eligibility for the study will be verified based on medical criteria

  2. Step 2

    Day 1 (Baseline Visit)

    You will receive a single intramuscular injection of either the study vaccine (mRNA-1010) or the comparison flu vaccine

    This is an observer-blind study, which means you will not know which vaccine you receive

  3. Step 3

    First week monitoring (Days 1-7)

    You will be monitored for any immediate reactions at the injection site (such as pain or swelling)

    Any body-wide reactions (such as fever or tiredness) will be recorded

  4. Step 4

    Follow-up period (Days 1-28)

    Any unexpected health changes will be documented

    A blood sample will be taken on Day 29 to measure your body's immune response to the vaccine

  5. Step 5

    Extended monitoring (Days 1-181)

    You will be monitored for approximately 6 months for any flu-like illness

    If you develop flu symptoms, a test will be performed to confirm if you have the flu

    Any significant medical events or serious health changes will be recorded

  6. Step 6

    End of study period

    The study concludes after approximately 181 days (6 months)

    Final health assessments will be performed

Who can join the trial?

8 criteria

  • Must be able to provide signed informed consent and follow all study requirements and restrictions
  • Must be an adult aged 18 years or older
  • Can be either male or female
  • For female participants who can become pregnant:
    • Must not be breastfeeding
    • Must use an acceptable form of birth control starting at least 28 days before the study and continuing until 90 days after the first day of the study
    • Must have a negative pregnancy test (urine or blood) during screening and before receiving the study treatment
    • Female participants who cannot become pregnant (for example, post-menopausal or surgically sterile) are eligible to participate
    • Must be willing to comply with all scheduled visits and study procedures as outlined in the study protocol

Who cannot join the trial?

12 criteria

  • History of severe allergic reactions to any vaccine components or previous influenza vaccines
  • Current participation in another clinical trial or use of any investigational drug within 28 days before study enrollment
  • Received any influenza vaccine within 6 months prior to screening
  • Active autoimmune disease requiring systemic treatment (a condition where the immune system attacks healthy cells in the body)
  • Compromised immune system or taking medications that suppress the immune system
  • Acute illness or fever (temperature ≥38.0°C/100.4°F) within 72 hours before vaccination
  • Pregnant or breastfeeding women
  • History of Guillain-Barré syndrome (a rare disorder where the immune system attacks the nerves)
  • Blood disorders or conditions that make you bleed or bruise easily
  • Active infection requiring medical treatment
  • Receipt of blood products or immunoglobulins within 3 months before study enrollment
  • Any medical condition that, in the opinion of the study doctor, makes participation unsafe
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Investigated drugs

  • mRNA-1010

    This is an investigational seasonal influenza vaccine using messenger RNA technology. It's designed to protect against influenza A and B strains. The vaccine works by teaching the body's cells to produce proteins that trigger an immune response against the flu virus.

  • Licensed Inactivated Seasonal Influenza Vaccine

    This is a standard, approved flu vaccine that contains inactivated (killed) flu viruses. It helps protect against seasonal influenza by stimulating the immune system to produce antibodies against the flu virus. This vaccine serves as the comparison (active control) in this study.

What is already known about the treatment

mRNA-1010 - An investigational seasonal influenza vaccine administered via intramuscular injection, currently being studied in Phase 3 clinical trials. This vaccine utilizes messenger RNA (mRNA) technology to stimulate the immune system's response against influenza A and B strains, similar to the technology used in some COVID-19 vaccines. The vaccine is being evaluated for safety, effectiveness, and immune response in adults aged 50 and older, with its primary mechanism involving the production of viral proteins that trigger protective antibody development. It represents a new approach to influenza vaccination, being compared to traditional licensed inactivated flu vaccines in clinical studies. Note: Since the trial data compares mRNA-1010 with a licensed seasonal influenza vaccine but doesn't specify which one, I've only provided the description for mRNA-1010.

Investigated diseases

Influenza - A highly contagious viral respiratory infection that affects the nose, throat, and sometimes the lungs. The virus spreads through tiny droplets when infected people cough, sneeze, or talk. Symptoms typically appear suddenly and include fever, chills, muscle aches, fatigue, headache, dry cough, and runny or stuffy nose. The illness usually develops within 1-4 days after exposure to the virus. Most people recover within a few days to less than two weeks.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516240-26-00Protocol codemRNA-1010-P304Estimated enrolment58 190 patientsSponsorModerna Inc.

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