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

NCT05624606

CompletedPhase 1, Phase 2

Sponsor: Sanofi Pasteur, a Sanofi Company

Conditions: Influenza Immunization

Interventions: Quadrivalent Influenza mRNA Vaccine MRT5410, Quadrivalent Recombinant Influenza vaccine RIV4, Quadrivalent Inactivated Influenza Standard Dose QIV-SD, Quadrivalent Inactivated Influenza High Dose QIV-HD

Countries: United States, Puerto Rico

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

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:

* 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.

Locations (25)

Huntington Park, California, United States
Long Beach, California, United States
North Hollywood, California, United States
San Diego, California, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
West Palm Beach, Florida, United States
Meridian, Idaho, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Norfolk, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
North Charleston, South Carolina, United States
Knoxville, Tennessee, United States
Austin, Texas, United States
Austin, Texas, United States
Humble, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Barrio Sabana, Puerto Rico
San Juan, Puerto Rico