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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: COVID-19 Immunization, Influenza Immunization

In brief

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.

Key facts

Study ID

NCT06695130

Run by

Sanofi

People needed

980

Starts

2024-11-18

Expected to finish

2026-04-03

Last updated by the study team

2026-05-05

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Inclusion criteria to be checked at Screening Visit:
• 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.
• Inclusion criteria to be checked at Visit 1 (Day [D]01):
• 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 to be checked at Screening Visit and at Visit 1 (D01):
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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