A Study on the Safety and Immunogenicity of Hexavalent Influenza mRNA Vaccine in Adult Participants 50 Years of Age and Older
NCT ID: NCT06744205
Last Updated: 2025-05-30
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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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
1162 participants
INTERVENTIONAL
2025-01-06
2026-04-16
Brief Summary
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Detailed Description
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* Study Duration: approximately 12 months for each participant
* Treatment: 1 injection of hexavalent vaccine, trivalent vaccine, or active control
* Visit frequency: Day (D) 01, D03, D09, D29, and D181; D366 (telephone call)
* Dose escalation with sequential enrollment of sentinel cohorts followed by parallel enrollment of the main cohort
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1 - Hexavalent (Combination 1)
Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 1)
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
Group 2 - Hexavalent (Combination 2)
Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 2)
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
Group 3 - Hexavalent (Combination 3)
Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 3)
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
Group 4 - Hexavalent (Combination 4)
Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 4)
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
Group 5 - Hexavalent (Combination 5)
Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 5)
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
Group 6 - Hexavalent (Combination 6)
Participants will receive single dose of hexavalent influenza mRNA vaccine composed of differing dose levels of TIV mRNA-HA Vaccine 1 in combination with TIV mRNA-NA (Combination 6)
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
Group 7 - TIV mRNA-HA Vaccine 1
Participants will receive a single dose of TIV mRNA-HA Vaccine 1
Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
Group 8 - TIV mRNA-NA
Participants will receive a single dose of TIV mRNA-NA
TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
Group 9 - TIV mRNA-HA Vaccine 2
Participants will receive single dose of TIV mRNA-HA Vaccine 2
TIV mRNA-HA Vaccine 2
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
Group 10 - QIV-SD
Participants will receive single dose of QIV-SD vaccine (for participants 50 to 64 years of age only)
Quadrivalent Influenza Standard Dose Vaccine
* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe
* Route of administration: Intramuscular injection
Group 11 - QIV-HD
Participants will receive single dose of QIV-HD vaccine
Quadrivalent Influenza Vaccine High Dose
* Pharmaceutical form: Liquid suspension for injection in pre-filled syringe
* Route of administration: Intramuscular injection
Interventions
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Trivalent (TIV) messenger ribonucleic acid (mRNA) hemagglutinin (HA) Vaccine 1
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
TIV mRNA-neuraminidase (NA)
* Pharmaceutical form: solution for injection in a vial
* Route of administration: Intramuscular injection
TIV mRNA-HA Vaccine 2
* Pharmaceutical form: solution for injection 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 Vaccine High Dose
* 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.
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 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)
* Known systemic hypersensitivity to any of the study intervention components (eg, polyethylene glycol, polysorbate); history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances; any allergic reaction (eg, anaphylaxis) after administration of mRNA vaccine
* Previous history of myocarditis, pericarditis, and/or myopericarditis
* Known history of previous episodes of Guillain-Barré syndrome, neuritis (including Bell's palsy), convulsions, encephalitis, transverse myelitis, and vasculitis
* Participants with an electrocardiogram that is consistent with possible myocarditis or pericarditis or, in the opinion of the investigator, demonstrates clinically relevant abnormalities that may affect participant safety or study results
* Self-reported thrombocytopenia, contraindicating intramuscular (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
* Chronic illness that, in the opinion of the Investigator, is at a stage where it might 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. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
* Participant who had acute infectious symptoms or a positive SARS-CoV-2 RT-PCR or antigen test in the past 10 days prior to the first visit (V01)
* Receipt of any vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Previous vaccination against influenza in the previous 6 months with an investigational or marketed vaccine
* Receipt of any mRNA vaccine/product in the 2 months preceding study intervention administration or planned receipt of any mRNA vaccine in the 2 months after study vaccination
* Participation at the time of study enrollment (or in the 4 weeks preceding study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
* Self-reported or documented seropositivity for human immunodeficiency virus, hepatitis B virus, or hepatitis C virus
50 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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Accel Research Sites Network - Birmingham- Site Number : 8400008
Birmingham, Alabama, United States
AMR Mobile- Site Number : 8400022
Mobile, Alabama, United States
Alliance for Multispeciality Research - Clinical Research Consortium- Site Number : 8400015
Tempe, Arizona, United States
AMR Miami- Site Number : 8400021
Coral Gables, Florida, United States
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400003
DeLand, Florida, United States
Alliance for Multispeciality Research - Fort Myers- Site Number : 8400013
Fort Myers, Florida, United States
Accel Research Sites - Maitland- Site Number : 8400007
Maitland, Florida, United States
Innovation Medical Research Center - Palmetto Bay- Site Number : 8400011
Palmetto Bay, Florida, United States
Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400001
Decatur, Georgia, United States
AMR - Chicago- Site Number : 8400012
Oak Brook, Illinois, United States
Alliance for Multispeciality Research - Newton- Site Number : 8400020
Newton, Kansas, United States
Alliance for Multispeciality Research - Wichita East- Site Number : 8400014
Wichita, Kansas, United States
Alliance for Multispeciality Research - Lexington- Site Number : 8400018
Lexington, Kentucky, United States
Boston Clinical Trials- Site Number : 8400009
Boston, Massachusetts, United States
ActivMed Practices & Research- Site Number : 8400005
Methuen, Massachusetts, United States
Quest Research Institute- Site Number : 8400010
Farmington Hills, Michigan, United States
Alliance for Multispeciality Research - Kansas City- Site Number : 8400019
Kansas City, Missouri, United States
AMR Las Vegas - Site Number : 8400016
Las Vegas, Nevada, United States
Coastal Carolina Research Center - North Charleston- Site Number : 8400002
North Charleston, South Carolina, United States
Alliance for Multispeciality Research - Knoxville- Site Number : 8400017
Knoxville, Tennessee, United States
Charlottesville Medical Research- Site Number : 8400004
Charlottesville, Virginia, United States
Investigational Site Number : 0360001
Botany, New South Wales, Australia
Investigational Site Number : 0360003
Bayswater, Victoria, Australia
Investigational Site Number : 0360002
Melbourne, Victoria, Australia
Countries
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Other Identifiers
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U1111-1303-3537
Identifier Type: REGISTRY
Identifier Source: secondary_id
FBP00021
Identifier Type: -
Identifier Source: org_study_id
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