Phase
Condition
Influenza
Healthy Volunteers
Treatment
Quadrivalent Influenza Standard Dose Vaccine
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
Quadrivalent Influenza Vaccine High Dose
Clinical Study ID
Ages > 50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant aged 50 years on the day of inclusion
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 contraceptive method orabstinence from at least 4 weeks prior to study intervention administration until atleast 12 weeks after study intervention administration.
A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 8 hours prior to administration of study intervention.
Exclusion
Exclusion Criteria:
Participants are not eligible for the study if any of the following criteria are met:
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 Guillain-Barré syndrome, neuritis (includingBell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
Participants with an electrocardiogram that is consistent with possible myocarditisor pericarditis or, in the opinion of the investigator, demonstrates clinicallyrelevant abnormalities that may affect participant safety or study results
Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccinationbased on Investigator's judgment
Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,contraindicating IM 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 judgement)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.
Alcohol, prescription drug, or substance abuse that, in the opinion of theInvestigator, might interfere with the study conduct or completion
Participant who had acute infectious symptoms or a positive SARS-CoV-2 RT-PCR orantigen test in the past 10 days prior to the first 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 or planned receipt of any mRNA vaccine in the 2 months after studyvaccination
Participation at the time of study enrollment (or in the 4 weeks preceding studyintervention administration) or planned participation during the present studyperiod in another clinical study investigating a vaccine, drug, medical device, ormedical procedure
Self-reported or documented seropositivity for human immunodeficiency virus,hepatitis B virus, or hepatitis C virus
Study Design
Study Description
Connect with a study center
Investigational Site Number : 0360001
Botany, New South Wales 2019
AustraliaActive - Recruiting
Investigational Site Number : 0360003
Bayswater, Victoria 3153
AustraliaActive - Recruiting
Investigational Site Number : 0360002
Melbourne, Victoria 3124
AustraliaActive - Recruiting
Accel Research Sites Network - Birmingham- Site Number : 8400008
Birmingham, Alabama 35216
United StatesActive - Recruiting
AMR Mobile- Site Number : 8400022
Mobile, Alabama 36608
United StatesActive - Recruiting
Alliance for Multispeciality Research - Clinical Research Consortium- Site Number : 8400015
Tempe, Arizona 85281
United StatesActive - Recruiting
AMR Miami- Site Number : 8400021
Coral Gables, Florida 33134
United StatesActive - Recruiting
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400003
DeLand, Florida 32720
United StatesActive - Recruiting
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400013
Fort Myers, Florida 33912
United StatesActive - Recruiting
Accel Research Sites - Maitland- Site Number : 8400007
Maitland, Florida 32751
United StatesActive - Recruiting
Innovation Medical Research Center - Palmetto Bay- Site Number : 8400011
Palmetto Bay, Florida 33157
United StatesActive - Recruiting
Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400001
Decatur, Georgia 30030-2627
United StatesActive - Recruiting
AMR - Chicago- Site Number : 8400012
Oak Brook, Illinois 60532
United StatesActive - Recruiting
Alliance for Multispeciality Research - Newton- Site Number : 8400020
Newton, Kansas 67114
United StatesActive - Recruiting
Alliance for Multispeciality Research - Wichita East- Site Number : 8400014
Wichita, Kansas 67207
United StatesActive - Recruiting
Alliance for Multispeciality Research - Lexington- Site Number : 8400018
Lexington, Kentucky 40509
United StatesActive - Recruiting
Boston Clinical Trials- Site Number : 8400009
Boston, Massachusetts 02131
United StatesActive - Recruiting
ActivMed Practices & Research - Methuen- Site Number : 8400005
Methuen, Massachusetts 01844
United StatesActive - Recruiting
Quest Research Institute- Site Number : 8400010
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
Alliance for Multispeciality Research - Kansas City- Site Number : 8400019
Kansas City, Missouri 64114
United StatesActive - Recruiting
AMR Las Vegas - Site Number : 8400016
Las Vegas, Nevada 89119
United StatesActive - Recruiting
Coastal Carolina Research Center - North Charleston- Site Number : 8400002
North Charleston, South Carolina 29405
United StatesActive - Recruiting
Alliance for Multispeciality Research - Knoxville- Site Number : 8400017
Knoxville, Tennessee 37920
United StatesActive - Recruiting
Charlottesville Medical Research- Site Number : 8400004
Charlottesville, Virginia 22911
United StatesActive - Recruiting
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