Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older

Completed · Phase 1/Phase 2

Conditions studied: Influenza Immunization

In brief

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 mRNA Vaccine MRT5410 compared to an active control (QIV SD, QIV HD \[adults ≥ 65 years of age only\], or RIV4) in adults 18 years of age and older.

Key facts

Study ID

NCT05624606

Run by

Sanofi Pasteur, a Sanofi Company

People needed

682

Starts

2022-11-28

Expected to finish

2024-03-28

Last updated by the study team

2025-03-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 IM vaccination based on Investigator's judgment
• Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM 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.

Where it is running

• Joint Clinical Trials Huntington Park Site Number : 8400032 — Huntington Park, California, United States
• Long Beach Clinical Trials Site Number : 8400056 — Long Beach, California, United States
• Velocity Clinical Research, North Hollywood Site Number : 8400063 — North Hollywood, California, United States
• California Research Foundation Site Number : 8400001 — San Diego, California, United States
• SIMEDHealth, LLC Site Number : 8400042 — Gainesville, Florida, United States
• Indago Research and Health Center Site Number : 8400002 — Hialeah, Florida, United States
• Research Centers of America Site Number : 8400011 — Hollywood, Florida, United States
• Florida International Research Center Site Number : 8400009 — Miami, Florida, United States
• Palm Beach Research Center Site Number : 8400041 — West Palm Beach, Florida, United States
• Velocity Clinical Research Site Number : 8400024 — Meridian, Idaho, United States
• Brengle Family Medicine Site Number : 8400040 — Indianapolis, Indiana, United States
• AMR Lexington Site Number : 8400035 — Lexington, Kentucky, United States
• Meridian Clinical Research Site Number : 8400017 — Norfolk, Nebraska, United States
• Velocity Clinical Research Site Number : 8400034 — Omaha, Nebraska, United States
• WR-CRCN, LLC Site Number : 8400060 — Las Vegas, Nevada, United States
• Coastal Carolina Research Center - N Charleston Site Number : 8400007 — North Charleston, South Carolina, United States
• AMR Knoxville Site Number : 8400021 — Knoxville, Tennessee, United States
• Elligo Health Research, Inc. Site Number : 8400037 — Austin, Texas, United States
• Tekton Research, Inc Site Number : 8400051 — Austin, Texas, United States
• DM Clinical Research Site Number : 8400046 — Humble, Texas, United States
• Clinical Trials of Texas, Inc. - PPDS Site Number : 8400043 — San Antonio, Texas, United States
• DM Clinical Research - Sugar Land Site Number : 8400045 — Sugar Land, Texas, United States
• Martin Diagnostic Clinic Site Number : 8400058 — Tomball, Texas, United States
• Investigational Site Number : 6300002 — Barrio Sabana, Puerto Rico
• Investigational Site Number : 6300001 — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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