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

Investigation of Safety and Immune Response to Quadrivalent Influenza mRNA Vaccine in Adults

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.

This study investigates the safety and immune response of a Quadrivalent Influenza mRNA Vaccine in adults aged 18 and older. The study will compare the effects of one dose of the investigational vaccine at different dose levels to an active control, which includes standard-dose and high-dose influenza vaccines. The purpose is to understand how the investigational vaccine works in producing an immune response.

Participants will receive a single intramuscular injection of the investigational vaccine or the active control. The study will monitor participants for any side effects and measure their immune response to the vaccine. Intramuscular means the injection is given into a muscle, and immunogenicity refers to the ability of the vaccine to provoke an immune response.

  • Who can participate: Adults aged 18 years or older who are not pregnant or breastfeeding are eligible. Participants must use effective contraception if of childbearing potential and should not have immune system deficiencies or recent history of certain illnesses.
  • Study details: Participants will receive a single injection of the investigational vaccine or a control vaccine. The study will monitor for side effects and measure immune responses. A placebo is not used in this study.
  • Study timelines: The study will last approximately 12 months.
Updated on 25 Mar 2025. Study ID: NCT05553301