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Sponsor: Sanofi Pasteur, a Sanofi Company
Conditions: Influenza Immunization
Interventions: Quadrivalent Influenza mRNA Vaccine MRT5407, Quadrivalent Recombinant Influenza Vaccine, Quadrivalent Influenza Standard Dose Vaccine, Quadrivalent Influenza High-Dose Vaccine
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 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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
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.
- Rolling Hills Estates, California, United States
- San Diego, California, United States
- San Diego, California, United States
- DeLand, Florida, United States
- Gainesville, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Miami, Florida, United States
- Miami, Florida, United States
- West Palm Beach, Florida, United States
- Melrose Park, Illinois, United States
- River Forest, Illinois, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Kansas City, Missouri, United States
- Omaha, Nebraska, United States
- North Charleston, South Carolina, United States
- Knoxville, Tennessee, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- San Antonio, Texas, United States
- Sugar Land, Texas, United States
- Barrio Sabana, Puerto Rico
- San Juan, Puerto Rico