Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5413 in Adult Participants18 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 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.

Key facts

Study ID

NCT05650554

Run by

Sanofi Pasteur, a Sanofi Company

People needed

682

Starts

2022-12-12

Expected to finish

2024-04-02

Last updated by the study team

2025-03-19

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…

• 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.

Where it is running

• Velocity Clinical Research-Chula Vista Site Number : 8400061 — Chula Vista, California, United States
• Velocity Gardena Site Number : 8400062 — Gardena, California, United States
• Long Beach Clinical Trials Site Number : 8400052 — Long Beach, California, United States
• Velocity Clinical Research, North Hollywood Site Number : 8400051 — North Hollywood, California, United States
• California Research Foundation Site Number : 8400006 — San Diego, California, United States
• Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400032 — DeLand, Florida, United States
• Velocity New Smyrna Beach Site Number : 8400063 — Edgewater, Florida, United States
• SIMEDHealth, LLC Site Number : 8400014 — Gainesville, Florida, United States
• Indago Research and Health Center Site Number : 8400044 — Hialeah, Florida, United States
• Cenexel Research Centers of America Site Number : 8400011 — Hollywood, Florida, United States
• Florida International Research Center Site Number : 8400045 — Miami, Florida, United States
• Suncoast Research Associates, LLC Site Number : 8400060 — Miami, Florida, United States
• Florida Pulmonary Research Center Site Number : 8400036 — Winter Park, Florida, United States
• Meridian Clinical Research Site Number : 8400022 — Savannah, Georgia, United States
• Velocity Clinical Research Site Number : 8400024 — Meridian, Idaho, United States
• DM Clinical Research - Chicago Site Number : 8400025 — River Forest, Illinois, United States
• Brengle Family Medicine Site Number : 8400039 — Indianapolis, Indiana, United States
• Meridian Clinical Research Site Number : 8400017 — Norfolk, Nebraska, United States
• Velocity Clinical Research Lincoln Site Number : 8400049 — Lincoln, Nebraska, United States
• Velocity Clinical Research Site Number : 8400008 — Omaha, Nebraska, United States
• Rochester Clinical Research. Inc. Site Number : 8400027 — Rochester, New York, United States
• Velocity Clinical Research Site Number : 8400001 — Cleveland, Ohio, United States
• Velocity Clinical Research - Providence Site Number : 8400019 — East Greenwich, Rhode Island, United States
• Coastal Carolina Research Center Site Number : 8400042 — North Charleston, South Carolina, United States
• ClinSearch Site Number : 8400013 — Chattanooga, Tennessee, United States

Full record on ClinicalTrials.gov

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