Safety and Immunogenicity of Quadrivalent Influenza mRNA Vaccine MRT5407 in Adult Participants18 Years of Age and Older
NCT ID: NCT05553301
Last Updated: 2025-01-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
560 participants
INTERVENTIONAL
2022-10-03
2024-01-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
Main Cohort:
* Open label (Sponsor, except laboratory testing personnel)
* Blinded (Sites, except for those preparing/administering study intervention)
PREVENTION
TRIPLE
Study Groups
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Group 1: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 1
participants will receive a single dose of QIV mRNA vaccine (dose level 1)
Quadrivalent Influenza mRNA Vaccine MRT5407
Pharmaceutical Form: Liquid frozen solution in a vial
Route of Administration: Intramuscular Injection
Group 2: Quadrivalent Influenza mRNA Vaccine MRT5407 dose level 2
participants will receive a single dose of QIV mRNA vaccine (dose level 2)
Quadrivalent Influenza mRNA Vaccine MRT5407
Pharmaceutical Form: Liquid frozen solution in a vial
Route of Administration: Intramuscular Injection
Group 3: RIV4
participants will receive a single dose of RIV4 vaccine
Quadrivalent Recombinant Influenza Vaccine
Pharmaceutical Form: Liquid frozen solution in a vial
Route of Administration: Intramuscular Injection
Group 4: QIV-SD
participants will receive a single dose of QIV-SD vaccine
Quadrivalent Influenza Standard Dose Vaccine
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe
Route of Administration: Intramuscular Injection
Group 5: QIV-HD
participants will receive a single dose of QIV -HD vaccine (for elderly only)
Quadrivalent Influenza High-Dose Vaccine
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe
Route of Administration: Intramuscular Injection
Interventions
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Quadrivalent Influenza mRNA Vaccine MRT5407
Pharmaceutical Form: Liquid frozen solution in a vial
Route of Administration: Intramuscular Injection
Quadrivalent Recombinant Influenza Vaccine
Pharmaceutical Form: Liquid frozen solution in a vial
Route of Administration: Intramuscular Injection
Quadrivalent Influenza Standard Dose Vaccine
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe
Route of Administration: Intramuscular Injection
Quadrivalent Influenza High-Dose Vaccine
Pharmaceutical Form: Liquid suspension for injection in pre-filled syringe
Route of Administration: Intramuscular Injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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Peninsula Research Associates Site Number : 8400025
Rolling Hills Estates, California, United States
Optimal Research Site Number : 8400059
San Diego, California, United States
California Research Foundation Site Number : 8400008
San Diego, California, United States
Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400052
DeLand, Florida, United States
SIMEDHealth, LLC Site Number : 8400024
Gainesville, Florida, United States
Indago Research and Health Center Site Number : 8400014
Hialeah, Florida, United States
Cenexel Research Centers of America Site Number : 8400048
Hollywood, Florida, United States
Dade Research Center Site Number : 8400011
Miami, Florida, United States
Suncoast Research Group, LLC Site Number : 8400038
Miami, Florida, United States
Florida International Research Center Site Number : 8400051
Miami, Florida, United States
Palm Beach Research Center Site Number : 8400020
West Palm Beach, Florida, United States
DM Clinical Research Site Number : 8400032
Melrose Park, Illinois, United States
DM Clinical Research - Chicago Site Number : 8400028
River Forest, Illinois, United States
Brengle Family Medicine Site Number : 8400005
Indianapolis, Indiana, United States
AMR Lexington Site Number : 8400054
Lexington, Kentucky, United States
AMR Kansas City Site Number : 8400006
Kansas City, Missouri, United States
Velocity Clinical Research Site Number : 8400003
Omaha, Nebraska, United States
Coastal Carolina Research Center - N Charleston Site Number : 8400010
North Charleston, South Carolina, United States
AMR Knoxville Site Number : 8400046
Knoxville, Tennessee, United States
Elligo Health Research Site Number : 8400056
Austin, Texas, United States
Sun Research Institute Site Number : 8400030
San Antonio, Texas, United States
Clinical Trials of Texas, Inc. Site Number : 8400026
San Antonio, Texas, United States
DM Clinical Research - Sugar Land Site Number : 8400031
Sugar Land, Texas, United States
Investigational Site Number : 6300003
Barrio Sabana, , Puerto Rico
Investigational Site Number : 6300002
San Juan, , Puerto Rico
Countries
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Other Identifiers
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U1111-1271-1302
Identifier Type: REGISTRY
Identifier Source: secondary_id
VAV00002
Identifier Type: -
Identifier Source: org_study_id
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