Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 Years of Age and Older

Investigation of Safety and Immunogenicity of an Influenza Vaccine

Not Recruiting
18 years or above
All
Phase 1/2
682 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 3 dose levels of Quadrivalent Influenza messenger ribonucleic acid (mRNA) Vaccine MRT5413 compared to an active control (QIVstandard-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 (US) and aged 21 years on the day of inclusion (Puerto Rico)
  • 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

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: NCT05650554

This study investigates the safety and immunogenicity, which means the ability to provoke an immune response, of a single intramuscular injection of a quadrivalent influenza mRNA vaccine. The study compares different doses of this investigational vaccine to existing influenza vaccines in adults aged 18 and older. A quadrivalent vaccine is designed to protect against four different flu viruses.

Participants will receive one injection of either the investigational vaccine or an active control vaccine. The study will measure the immune response and monitor for any side effects. An intramuscular injection is a way of delivering a vaccine through the muscle, usually in the upper arm.

  • Who can participate: Adults aged 18 years and older in the US, and 21 years and older in Puerto Rico, may participate. Women must not be pregnant or breastfeeding and must agree to use contraception if of childbearing potential. Participants must not have certain health conditions like immunodeficiency or a history of myocarditis.
  • Study details: Participants will receive one injection of either the investigational vaccine or a control vaccine. The study will monitor their immune response and any side effects. A placebo is not used in this study.
  • Study Timelines: The study will last approximately 12 months.