Study to Evaluate the Safety and the Immunogenicity of a Second Generation Structurally Designed mRNA Vaccine Candidate Against Pandemic Influenza H5 HA Strain in Healthy Adult Participants Aged 18 Years and Older
NCT ID: NCT06907511
Last Updated: 2026-01-16
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
720 participants
INTERVENTIONAL
2025-04-17
2026-12-01
Brief Summary
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The study will aim to identify the appropriate dose for further clinical development of a potential pandemic response vaccine.
The study also includes an extension phase for one of the 3 dose levels of the pandemic flu H5 HA mRNA SD2 vaccine to collect additional safety and the immunogenicity data for this specific dose of the vaccine. During this Extension Phase, an additional 480 participants will be randomized according to a 1:1 ratio and stratified by age (≥ 18 to \< 65 years and ≥ 65 years) to receive either the low dose of the pandemic flu H5 HA mRNA DS2 vaccine (Group 1) or placebo (Group 4). This extension will enhance the safety database and improve precision of the immunogenicity results for the selected dose while preserving the original study design integrity.
The study duration per participant will be approximately 13 months. There will be two injections of placebo or pandemic flu H5 mRNA vaccine 21 days apart at high, medium and low doses.
Study visits/contact include: 7 study visits and 1 telephone call. Vaccination visits (including blood samples) will occur at Day 01 and Day 22. Short-term follow-up visits (including blood samples) will occur 8 and 21 days after each injection. Participants will be also followed up (including blood samples) at 3 and 6 months after 2nd injection, and at 12 months after 2nd injection for safety.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1: Pandemic flu H5 HA mRNA SD2 vaccine (Low dose)
Participants will receive two injections of low dose pandemic flu H5 HA mRNA SD2 vaccine
Extension Phase:
Additional participants will receive two injections 21 days apart of pandemic flu H5 HA mRNA SD2 vaccine at low dose
Pandemic flu H5 HA mRNA SD2 vaccine
Pharmaceutical Form:
Suspension in a vial
Route of Administration:
Intramuscular injection
Group 2: Pandemic flu H5 HA mRNA SD2 vaccine (Medium dose)
Participants will receive two injections of medium dose pandemic flu H5 HA mRNA SD2 vaccine
Pandemic flu H5 HA mRNA SD2 vaccine
Pharmaceutical Form:
Suspension in a vial
Route of Administration:
Intramuscular injection
Group 3: Pandemic flu H5 HA mRNA SD2 vaccine (High dose)
Participants will receive two injections of high dose pandemic flu H5 HA mRNA SD2 vaccine
Pandemic flu H5 HA mRNA SD2 vaccine
Pharmaceutical Form:
Suspension in a vial
Route of Administration:
Intramuscular injection
Group 4: Placebo
Participants will receive two injections of placebo
Extension Phase:
Additional participants will receive two injections 21 days apart of placebo
Placebo
Pharmaceutical Form:
Liquid solution in a vial
Route of Administration:
Intramuscular injection
Interventions
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Pandemic flu H5 HA mRNA SD2 vaccine
Pharmaceutical Form:
Suspension in a vial
Route of Administration:
Intramuscular injection
Placebo
Pharmaceutical Form:
Liquid solution in a vial
Route of Administration:
Intramuscular injection
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 patient's potential participation in a clinical trial.
18 Years
ALL
Yes
Sponsors
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Sanofi
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
Accel Research Sites - Lakeland Clinical Research Unit- Site Number : 8400006
Lakeland, Florida, United States
Accel Research Sites - St. Petersburg - Largo- Site Number : 8400004
Largo, Florida, 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- 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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VBS00002 Plain Language Results Summary
Other Identifiers
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U1111-1314-5493
Identifier Type: OTHER
Identifier Source: secondary_id
VBS00002
Identifier Type: -
Identifier Source: org_study_id
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