Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
NCT ID: NCT06727058
Last Updated: 2026-01-21
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
276 participants
INTERVENTIONAL
2024-12-09
2026-03-31
Brief Summary
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The duration per participant will be approximately 13 months.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
TRIPLE
Study Groups
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Group 1: Low Dose Pandemic flu H5 mRNA vaccine
Participants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Pandemic flu H5 mRNA vaccine
Pharmaceutical Form: Suspension for injection
Route of Administration: Intramuscular (IM)
Group 2: Medium Dose Pandemic flu H5 mRNA vaccine
Participants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Pandemic flu H5 mRNA vaccine
Pharmaceutical Form: Suspension for injection
Route of Administration: Intramuscular (IM)
Group 3: High Dose Pandemic flu H5 mRNA vaccine
Participants will receive 2 injections of pandemic flu H5 mRNA vaccine 21 days apart (at Day 01 and Day 22)
Pandemic flu H5 mRNA vaccine
Pharmaceutical Form: Suspension for injection
Route of Administration: Intramuscular (IM)
Group 4: Placebo
Participants will receive 2 injections of placebo 21 days apart (at Day 01 and Day 22)
Placebo
Pharmaceutical Form: Liquid solution for injection
Route of Administration: Intramuscular (IM)
Interventions
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Pandemic flu H5 mRNA vaccine
Pharmaceutical Form: Suspension for injection
Route of Administration: Intramuscular (IM)
Placebo
Pharmaceutical Form: Liquid solution for injection
Route of Administration: Intramuscular (IM)
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 each study intervention administration until at least 12 weeks after the last 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 before the first dose of study intervention.
Exclusion Criteria
* 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 an mRNA vaccine .
* Previous history of myocarditis, pericarditis, and/or myopericarditis.
* Known history of previous episodes of Guillain-Barré Syndrome (GBS), 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 IM injection based on investigator's judgment.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection 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 judgment) or febrile illness (temperature ≥ 38.0°C \[≥ 100.4°F\]) on the day of study intervention. 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 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) reverse transcriptase polymerase chain reaction (RT PCR) or antigen test in the past 10 days prior to the first visit (V)01.
* Receipt of any vaccine other than an mRNA vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine other than an mRNA vaccine in the 3 weeks following the second dose of the study intervention .
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* 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 the second dose of the study intervention.
* 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.
* Previous history of participation in an H5 influenza A vaccine study. This includes any influenza subtypes that contain H5 such as H5N1, H5N8, or H5N6.
Note: The above information is not intended to contain all considerations relevant to a 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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Locations
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Velocity Clinical Research - San Diego- Site Number : 8400013
La Mesa, California, United States
Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400002
DeLand, Florida, United States
ARSN-Lakeland CRU- Site Number : 8400006
Lakeland, Florida, United States
Accel Research Sites - St. Petersburg- Site Number : 8400004
Largo, Florida, United States
Atlanta Clinical Research Center- Site Number : 8400007
Atlanta, Georgia, United States
Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400003
Decatur, Georgia, United States
QUEST Research Institute- Site Number : 8400014
Bingham Farms, Michigan, United States
Velocity Clinical Research - Norfolk- Site Number : 8400015
Norfolk, Nebraska, United States
Velocity Clinical Research - Omaha- Site Number : 8400012
Omaha, Nebraska, United States
Velocity Clinical Research - Springdale- Site Number : 8400010
Cincinnati, Ohio, United States
Coastal Carolina Research Center - North Charleston- Site Number : 8400001
North Charleston, South Carolina, United States
Olympus Clinical Research - Sugar Land- Site Number : 8400009
Sugar Land, Texas, United States
Velocity Clinical Research, Salt Lake City- Site Number : 8400011
West Jordan, Utah, United States
Charlottesville Medical Research- Site Number : 8400005
Charlottesville, Virginia, United States
Countries
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Related Links
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VBS00001 Plain Language Results Summary
Other Identifiers
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VBS00001
Identifier Type: -
Identifier Source: org_study_id
U1111-1309-8833
Identifier Type: OTHER
Identifier Source: secondary_id
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