Study of a Combination Vaccine Comprised of Different Recombinant Spike Antigen Levels of a Matrix-M Adjuvanted Recombinant COVID-19 Vaccine and Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older

NCT ID: NCT06695130

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 980 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2026-04-03

Brief Summary

Study VBT00002 is planned to be a Phase 1/2, randomized, modified double-blind, active-controlled, multi-center study to be conducted in approximately 980 adults aged 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinant COVID-19 vaccine (rC19) vaccine comprised of RIV combined with different recombinant Spike (rS) antigen levels of rC19 compared to RIV alone, rC19 (dose 1) alone, and RIV and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the RIV alone, rC19 (dose 1) alone, and RIV + 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 Day(D) 01
• Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose)
• The visit frequency for participants will be D01 and D30, and D09-D366 (telephone call)

Number of Participants:

Approximately 980 participants are expected to be randomized.

Conditions

COVID-19 Immunization; Influenza Immunization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Group 1: RIV (in right or left deltoid) and placebo (in opposite deltoid)

two IM injections on D01

Group Type: EXPERIMENTAL

RIV (recombinant influenza vaccine)

Intervention Type: BIOLOGICAL

Influenza, inactivated, split virus or surface antigen

Placebo (0.9% NaCl)

Intervention Type: OTHER

Normal saline

Group 2: rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid)

two IM injections on D01

Group Type: EXPERIMENTAL

rC19 (dose 1)

Intervention Type: BIOLOGICAL

Protein subunit

Placebo (0.9% NaCl)

Intervention Type: OTHER

Normal saline

Group 3: RIV (in right or left deltoid) and rC19 (dose 1) (in opposite deltoid)

two IM injections on D01

Group Type: EXPERIMENTAL

RIV (recombinant influenza vaccine)

Intervention Type: BIOLOGICAL

Influenza, inactivated, split virus or surface antigen

rC19 (dose 1)

Intervention Type: BIOLOGICAL

Protein subunit

Group 4: RIV + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid)

two IM injections on D01

Group Type: EXPERIMENTAL

RIV + rC19 (dose 1)

Intervention Type: BIOLOGICAL

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

Placebo (0.9% NaCl)

Intervention Type: OTHER

Normal saline

Group 5: RIV + rC19 (dose 2) (in right or left deltoid) and placebo

two IM injections on D01

Group Type: EXPERIMENTAL

RIV + rC19 (dose 2)

Intervention Type: BIOLOGICAL

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

Placebo (0.9% NaCl)

Intervention Type: OTHER

Normal saline

Group 6: RIV + rC19 (dose 3) (in right or left deltoid) and placebo

two IM injections on D01

Group Type: EXPERIMENTAL

RIV + rC19 (dose 3)

Intervention Type: BIOLOGICAL

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

Placebo (0.9% NaCl)

Intervention Type: OTHER

Normal saline

Group 7: RIV + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid)

two IM injections on D01

Group Type: EXPERIMENTAL

RIV + rC19 (dose 4)

Intervention Type: BIOLOGICAL

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

Placebo (0.9% NaCl)

Intervention Type: OTHER

Normal saline

Interventions

RIV (recombinant influenza vaccine)

Influenza, inactivated, split virus or surface antigen

Intervention Type: BIOLOGICAL

rC19 (dose 1)

Protein subunit

Intervention Type: BIOLOGICAL

RIV + rC19 (dose 1)

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

Intervention Type: BIOLOGICAL

RIV + rC19 (dose 2)

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

Intervention Type: BIOLOGICAL

RIV + rC19 (dose 3)

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

Intervention Type: BIOLOGICAL

RIV + rC19 (dose 4)

RIV component: Influenza, inactivated, split virus or surface antigen NVXC19 component: Protein subunit

Intervention Type: BIOLOGICAL

Placebo (0.9% NaCl)

Normal saline

Intervention Type: OTHER

Other Intervention Names

Recombinant influenza vaccine; Novavax's adjuvanted recombinant COVID-19

Eligibility Criteria

Inclusion Criteria

• Aged 50 years or older on the day of inclusion Informed consent
• 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 inclusions
• 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 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 (for glucocorticoids, ≥ 10 milligrams/day of prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• 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 that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion .
• Any illness that, in the opinion of the investigator, would pose a health risk to the participant if enrolled.
• 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 or stroke risk factors, which may include untreated/uncontrolled hypertension, hyperlipidemia, or diabetes; active smoking; obesity, based on investigator's judgment; history of thromboembolic disease; cardiac structural abnormality; atrial fibrillation; carotid stent placement; or family history of stroke.

Prior/concomitant therapy

• 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central Phoenix Medical Clinic- Site Number : 8400009

Phoenix, Arizona, United States

Synexus Clinical Research US, Inc. - Cerritos- Site Number : 8400002

Cerritos, California, United States

Synexus Clinical Research US - Vista- Site Number : 8400010

Vista, California, United States

Optimal Research - Florida- Site Number : 8400006

Melbourne, Florida, United States

Synexus Clinical Research US - Orlando- Site Number : 8400007

Orlando, Florida, United States

Optimal Research - Illinois- Site Number : 8400008

Peoria, Illinois, United States

Synexus Clinical Research US - Evansville- Site Number : 8400004

Evansville, Indiana, United States

Walgreens Clinical Trials-Malden- Site Number : 8400012

Malden, Massachusetts, United States

Synexus Clinical Research US - Minneapolis- Site Number : 8400011

Richfield, Minnesota, United States

Synexus-Las Vegas- Site Number : 8400005

Las Vegas, Nevada, United States

Synexus Clinical Research US - Cincinnati- Site Number : 8400003

Cincinnati, Ohio, United States

Synexus Clinical Research US - Anderson- Site Number : 8400001

Anderson, South Carolina, United States

Countries

United States

Other Identifiers

VBT00002

Identifier Type: -

Identifier Source: org_study_id