Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and High-Dose Inactivated Influenza Vaccine in Adult Participants 50 Years of Age and Older
NCT ID: NCT06695117
Last Updated: 2025-04-01
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
980 participants
INTERVENTIONAL
2024-11-19
2026-04-01
Brief Summary
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The purpose of the study is to assess the safety and immunogenicity of IIV-HD (high-dose inactivated influenza vaccine) + rC19 (adjuvanted recombinant COVID-19 vaccine) vaccine comprised of IIV-HD combined with different recombinant Spike (rS) antigen levels of rC19 compared to IIV-HD alone, rC19 (dose 1) alone, and IIV-HD and rC19 (dose 1) (coadministered in opposite arms).
Placebo will be coadministered in the IIV-HD alone, rC19 (dose 1) alone, and IIV-HD + rC19 study groups to control for the number of injections and to maintain observer-blinding.
Thus, each participant will receive two injections at enrollment, one in each deltoid muscle.
Study details include:
* The study duration will be approximately 12 months
* Study intervention will be administered via a single intramuscular (IM) injection into the right and left deltoid muscles on D01
* Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose)
* The visit frequency will be D01, D09 (telephone call), D30, D182 (telephone call), and D366 (telephone call)
Number of Participants:
Approximately 980 participants are expected to be randomized.
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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
Modified double-blind:
* Investigator, participants, and laboratory personnel will be blinded
* Clinical site staff preparing/administering the study vaccines will be unblinded
* Sponsor study staff will be blinded, except for dedicated staff involved in interim analysis, who will be unblinded at the time of interim analysis, and for dedicated staff involved in assessing criteria for safety surveillance
Study Groups
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Group 1: IIV-HD (in right or left deltoid) and placebo (in opposite deltoid)
two IM injections on D01
IIV-HD
Inactivated, split-virion
Placebo (0.9% NaCl)
Normal saline
Group 2: rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid)
two IM injections on D01
rC19 (dose 1)
Protein subunit
Placebo (0.9% NaCl)
Normal saline
Group 3: IIV-HD (in right or left deltoid) and rC19 (dose1) (in opposite deltoid)
two IM injections on D01
IIV-HD
Inactivated, split-virion
rC19 (dose 1)
Protein subunit
Group 4: IIV-HD + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid)
two IM injections on D01
IIV-HD + rC19 (dose 1)
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
Placebo (0.9% NaCl)
Normal saline
Group 5: IIV-HD + rC19 (dose 2) (in right or left deltoid) and placebo (in opposite deltoid)
two IM injections on D01
IIV-HD + rC19 (dose 2)
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
Placebo (0.9% NaCl)
Normal saline
Group 6: IIV-HD + rC19 (dose 3) (in right or left deltoid) and placebo (in opposite deltoid)
two IM injections on D01
IIV-HD + rC19 (dose 3)
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
Placebo (0.9% NaCl)
Normal saline
Group 7: IIV-HD + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid)
two IM injections on D01
IIV-HD + rC19 (dose 4)
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
Placebo (0.9% NaCl)
Normal saline
Interventions
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IIV-HD
Inactivated, split-virion
rC19 (dose 1)
Protein subunit
IIV-HD + rC19 (dose 1)
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
IIV-HD + rC19 (dose 2)
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
IIV-HD + rC19 (dose 3)
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
IIV-HD + rC19 (dose 4)
IIV-HD component: Inactivated, split-virion rC19 component: Protein subunit
Placebo (0.9% NaCl)
Normal saline
Eligibility Criteria
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Inclusion Criteria
* Informed consent form has been signed and dated.
* Able to attend all scheduled visits and to comply with all study procedures.
* Participant must be able to receive an injection in the deltoid muscle of both arms.
* Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine.
* Aged 50 years or older on the day of inclusion
* Participants who are healthy or with pre-existing stable condition (defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 12 weeks before enrollment), as determined by medical evaluation including medical history and physical examination.
* 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 post-menopausal 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 4 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) on the day of enrollment before the first dose of study intervention.
* Informed consent form has been signed and dated.
* Able to attend all scheduled visits and to comply with all study procedures.
* Participant must be able to receive an injection in the deltoid muscle of both arms.
* Participant must have completed a primary vaccination series against SARS-CoV-2 and at least 1 booster with a locally authorized or approved COVID-19 vaccine.
Exclusion Criteria
* Known systemic hypersensitivity to any of the study intervention components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances .
* Self-reported thrombocytopenia, contraindicating intramuscular injection, based on investigator's judgment.
* Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular injection, based on investigator's judgment.
* Chronic illness (1) 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 judgment) or febrile illness (temperature ≥ 100.4°F) on the day of study intervention administration. 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.
* History of serious adverse reaction to any influenza or COVID-19 vaccines.
* Personal or family history of Guillain-Barré syndrome.
* Prior history of myocarditis, pericarditis, or myopericarditis.
* Prior history of stroke, transient ischemic attack, or stroke risk factors, which may include untreated/uncontrolled hypertension, untreated/uncontrolled hyperlipidemia, active smoking, atrial fibrillation, and additional risk factors, based on investigator's judgment, which may include history of thromboembolic disease, obesity, cardiac structural or valvular abnormality, carotid stent placement, or family history of stroke..
* Receipt of any vaccine in the 4 weeks preceding study intervention administration or planned receipt of any vaccine prior to the second blood draw (ie, approximately in the 28 days following study intervention administration .
* Previous vaccination against influenza (in the previous 6 months) with an investigational or marketed vaccine.
* Previous vaccination against COVID-19 (in the previous 6 months) with an investigational or marketed vaccine OR history of COVID-19 in the previous 6 months .
* Receipt of immune globulins, blood or blood-derived products in the past 3 months.
* 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.
* Deprived of freedom by an administrative or court order, or being in an emergency setting, or hospitalized involuntarily.
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
1. Chronic illness may include, but is not limited to, cardiac disorders, hypertension, pulmonary disease, renal disorders, auto-immune disorders, diabetes mellitus, psychiatric disorders, neurologic disorders, or chronic infection
50 Years
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Simon Williamson Clinic - Birmingham- Site Number : 8400003
Birmingham, Alabama, United States
AES - DRS - Optimal Research Alabama - Huntsville Site Number : 8400006
Huntsville, Alabama, United States
Orange Grove Family Practice- Site Number : 8400012
Tucson, Arizona, United States
Synexus Clinical Research US, Inc. - The Villages Site Number : 8400011
The Villages, Florida, United States
Synexus Clinical Research US - Atlanta- Site Number : 8400001
Atlanta, Georgia, United States
Synexus Clinical Research- Site Number : 8400004
Chicago, Illinois, United States
Synexus Clinical Research - St. Louis- Site Number : 8400010
Creve Coeur, Missouri, United States
Synexus New York Site Number : 8400007
New York, New York, United States
Optimal Research, LLC Site Number : 8400002
Austin, Texas, United States
Synexus Clinical Research US - Dallas- Site Number : 8400005
Dallas, Texas, United States
Synexus Clinical Research US - San Antonio- Site Number : 8400009
San Antonio, Texas, United States
Synexus Salt Lake City Site Number : 8400008
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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U1111-1310-5034
Identifier Type: REGISTRY
Identifier Source: secondary_id
VBT00001
Identifier Type: -
Identifier Source: org_study_id
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