Phase
Condition
N/ATreatment
Quadrivalent Influenza mRNA Vaccine MRT5429
Quadrivalent Influenza mRNA Vaccine MRT5424
Quadrivalent Influenza mRNA Vaccine MRT5421
Clinical Study ID
Ages > 18 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria: - Aged from 18 years on the day of inclusion or aged from 21 years on the days of inclusion, depending on the countries.
A female participant is eligible to participate if she is not pregnant orbreastfeeding and one of the following conditions applies:
Is of non-childbearing potential. To be considered of non-childbearingpotential, a female must be postmenopausal for at least 1 year, or surgicallysterile OR
Is of childbearing potential and agrees to use an effective contraceptivemethod or abstinence from at least 4 weeks prior to study interventionadministration until at least 12 weeks after study intervention administration.
A female participant of childbearing potential must have a negative highly sensitivepregnancy test (urine or serum as required by local regulation) within 8 hours
Exclusion
before the 1st dose of study intervention Exclusion Criteria: Participants areexcluded from the study if any of the following criteria apply:
Known or suspected congenital or acquired immunodeficiency; or receipt ofimmunosuppressive 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 3months)
Known systemic hypersensitivity to any of the study intervention components (eg,polyethylene glycol, polysorbate); history of a life-threatening reaction to thestudy interventions used in the study or to a product containing any of the samesubstances; any allergic reaction (eg, anaphylaxis) after administration of mRNAvaccine
Previous history of myocarditis, pericarditis, and / or myopericarditis
Known history of previous episodes of Gillian-Barre Syndrome (GBS), neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, andvasculitis
Participants with an ECG that is consistent with possible myocarditis orpericarditis or, in the opinion of the investigator, demonstrates clinicallyrelevant abnormalities that may affect participant safety or study results
Self-reported thrombocytopenia, contraindicating Intramuscular vaccination based onInvestigator's judgment
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating Intramuscular vaccination based on Investigator's judgment
Chronic illness that, in the opinion of the Investigator, is at a stage where itmight interfere with study conduct or completion
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. Aprospective participant should not be included in the study until the condition hasresolved or the febrile event has subsided
Participant who had acute infection symptoms or a positive SARS-CoV-2 RT-PCR orantigen test in the past 10 days prior to the 1st visit (V01)
Receipt of any vaccine in the 4 weeks preceding study intervention administration orplanned receipt of any vaccine in the 4 weeks following study interventionadministration
Receipt of immune globulins, blood or blood-derived products in the past 3 months
Previous vaccination against influenza in the previous 6 months with aninvestigational or marketed vaccine
Receipt of any mRNA vaccine/product in the 2 months preceding study interventionadministration NOTE: The above information is not intended to contain allconsiderations relevant to a patient's potential participation in a clinical trial.
Study Design
Study Description
Connect with a study center
Investigational Site Number : 3400001
San Pedro Sula, 21104
HondurasSite Not Available
Investigational Site Number : 6300002
Barrio Sabana, 00694
Puerto RicoSite Not Available
Coastal Clinical Research, Inc. Site Number : 8400050
Mobile, Alabama 36608
United StatesSite Not Available
Alliance for Multispecialty Research- Phoenix Site Number : 8400035
Tempe, Arizona 85281
United StatesSite Not Available
Smart Cures Clinical Research Site Number : 8400044
Anaheim, California 92806
United StatesSite Not Available
Velocity Clinical Research Site Number : 8400048
La Mesa, California 91942
United StatesSite Not Available
Long Beach Clinical Trials Site Number : 8400013
Long Beach, California 90806
United StatesSite Not Available
California Research Foundation Site Number : 8400038
San Diego, California 92123-1881
United StatesSite Not Available
Accel Clinical Research-Deland Clinical Research Unit Site Number : 8400001
DeLand, Florida 32720-0834
United StatesSite Not Available
SIMEDHealth, LLC Site Number : 8400011
Gainesville, Florida 32607
United StatesSite Not Available
Indago Research and Health Center Site Number : 8400032
Hialeah, Florida 33012
United StatesSite Not Available
Cenexel Research Centers of America Site Number : 8400037
Hollywood, Florida 33024
United StatesSite Not Available
Research Centers of America Site Number : 8400037
Hollywood, Florida 33024
United StatesSite Not Available
Clinical Site Partners Site Number : 8400058
Leesburg, Florida 34748
United StatesSite Not Available
Suncoast Research Group, LLC Site Number : 8400015
Miami, Florida 33135
United StatesSite Not Available
Great Lakes Clinical Trials Site Number : 8400059
Chicago, Illinois 60640
United StatesSite Not Available
Brengle Family Medicine Site Number : 8400045
Indianapolis, Indiana 46260
United StatesSite Not Available
AMR El Dorado Site Number : 8400041
El Dorado, Kansas 67042
United StatesSite Not Available
AMR Wichita East Site Number : 8400039
Wichita, Kansas 67207
United StatesSite Not Available
AMR Lexington Site Number : 8400042
Lexington, Kentucky 40509
United StatesSite Not Available
Velocity Clinical Research Site Number : 8400053
Metairie, Louisiana 70006
United StatesSite Not Available
AMR New Orleans Site Number : 8400040
New Orleans, Louisiana 70119
United StatesSite Not Available
Velocity Clinical Research- New Orleans Site Number : 8400053
New Orleans, Louisiana 70119
United StatesSite Not Available
Optimal Research, LLC Rockville Site Number : 8400025
Rockville, Maryland 20850
United StatesSite Not Available
The Alliance for Multispecialty Research - KCM, LLC Site Number : 8400034
Kansas City, Missouri 64114
United StatesSite Not Available
Sundance Clinical Research, LLC Site Number : 8400012
Saint Louis, Missouri 63141
United StatesSite Not Available
Velocity Clinical Research Norfolk Site Number : 8400046
Norfolk, Nebraska 68701
United StatesSite Not Available
Velocity Clinical Research, Omaha Site Number : 8400008
Omaha, Nebraska 68134
United StatesSite Not Available
Rochester Clinical Research. Inc. Site Number : 8400005
Rochester, New York 14609
United StatesSite Not Available
Aventiv Research Columbus Site Number : 8400020
Columbus, Ohio 43213
United StatesSite Not Available
AMR Norman Site Number : 8400054
Norman, Oklahoma 73069
United StatesSite Not Available
Coastal Carolina Research Center Site Number : 8400014
North Charleston, South Carolina 29405
United StatesSite Not Available
WR-ClinSearch, LLC Site Number : 8400028
Chattanooga, Tennessee 37421
United StatesSite Not Available
AMR Knoxville Site Number : 8400043
Knoxville, Tennessee 37909
United StatesSite Not Available
Elligo Health Research, Inc. Site Number : 8400049
Austin, Texas 78704
United StatesSite Not Available
Clinical Trials of Texas, Inc. - PPDS Site Number : 8400029
San Antonio, Texas 78229
United StatesSite Not Available
DM Clinical Research/Pediatric Healthcare of Northwest Houston Site Number : 8400056
Tomball, Texas 77375
United StatesSite Not Available
Cenexel JBR Site Number : 8400051
Salt Lake City, Utah 84107
United StatesSite Not Available
JBR Clinical Research Site Number : 8400051
Salt Lake City, Utah 84107
United StatesSite Not Available
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