Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5410 in Adult Participants 18 Years of Age and Older
Influenza Immunization
About this trial
This is an interventional prevention trial for Influenza Immunization
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.
Sites / Locations
- Joint Clinical Trials Huntington Park-Site Number:8400032
- Long Beach Clinical Trials-Site Number:8400056
- Velocity Clinical Research, North Hollywood-Site Number:8400063
- California Research Foundation-Site Number:8400001
- SIMEDHealth, LLC-Site Number:8400042
- Indago Research and Health Center-Site Number:8400002
- Research Centers of America-Site Number:8400011
- Florida International Research Center-Site Number:8400009
- Palm Beach Research Center-Site Number:8400041
- Velocity Clinical Research-Site Number:8400024
- Brengle Family Medicine-Site Number:8400040
- AMR Lexington-Site Number:8400035
- Meridian Clinical Research-Site Number:8400017
- Meridian Clinical Research-Site Number:8400034
- WR-CRCN, LLC-Site Number:8400060
- Coastal Carolina Research Center - N Charleston-Site Number:8400007
- ClinSearch-Site Number:8400013
- AMR Knoxville-Site Number:8400021
- Elligo Health Research, Inc.-Site Number:8400037
- Tekton Research, Inc-Site Number:8400051
- Clinical Trials of Texas, Inc. - PPDS-Site Number:8400043
- DM Clinical Research - Sugar Land-Site Number:8400045
- DM Clinical Research-Site Number:8400046
- Martin Diagnostic Clinic-Site Number:8400058
- Investigational Site Number :6300002
- Investigational Site Number :6300001
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Active Comparator
Group 1: Quadrivalent Influenza mRNA Vaccine MRT5410 low dose
Group 2: Quadrivalent Influenza mRNA Vaccine MRT5410 medium dose
Group 3: Quadrivalent Influenza mRNA Vaccine MRT5410 high dose
Group 4: RIV4
Group 5: QIV-SD
Group 6: QIV-HD
participants will receive a single dose (low) of QIV mRNA vaccine
participants will receive a single dose (medium) of QIV mRNA vaccine
participants will receive a single dose (high) of QIV mRNA vaccine
participants will receive a single dose of RIV4 vaccine
participants will receive a single dose of QIV-SD vaccine
participants will receive a single dose of QIV -HD vaccine