Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older

Investigating the Safety and the Body's Defense Against Infections of an Influenza mRNA Vaccine

Not Recruiting
18 years or above
All
Phase 1/2
560 participants needed

Study Overview

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of up to 2 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5407 compared to an active control (QIV standard-dose (SD), QIV high-dose (HD) [adults ≥ 65 years of age only], or quadrivalent recombinant influenza vaccine (RIV4)) in adults 18 years of age and older.

Study Details

Study duration is approximately 12 months.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Influenza Immunization
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • Aged 18 years on the day of inclusion
  • A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
    • Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be postmenopausal for at least 1 year, or surgically sterile OR
    • Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 12 weeks after study intervention administration.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Previous history of myocarditis, pericarditis, and / or myopericarditis
  • Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based on Investigator's judgment
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating Intramuscular vaccination based on Investigator's judgment
  • Moderate or severe acute illness / infection (according to Investigator's judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of vaccination. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
  • Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
  • Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration

NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Updated on 25 Mar 2025. Study ID: NCT05553301

This study investigates the safety and immune response of a single injection of an investigational influenza mRNA vaccine in adults aged 18 and older. The study compares two different dose levels of the investigational vaccine to standard flu vaccines, including a standard-dose, a high-dose for those 65 and older, and a recombinant vaccine. The goal is to understand how well the investigational vaccine works and how safe it is for different age groups.

Participants will receive an injection of either the investigational vaccine or one of the standard vaccines. The study will monitor the participants for any side effects and measure their immune response to the vaccine. The investigational vaccine uses mRNA technology, which is a way to teach the body to recognize and fight the flu virus without using the live virus itself.

  • Who can participate: Adults 18 years and older who are not pregnant and meet specific health criteria can participate. They should not have conditions like immunodeficiency or have received certain treatments recently.
  • Study details: Participants will receive a single injection and be monitored for side effects and immune response. The study compares the investigational vaccine with standard flu vaccines.
  • Study Timelines: The study will last approximately 12 months.