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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
NCT06695117 · View on ClinicalTrials.gov ↗
Study Summary
Study VBT00001 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 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.
Conditions Studied
Interventions
- BIOLOGICAL IIV-HD
- BIOLOGICAL rC19 (dose 1)
- BIOLOGICAL IIV-HD + rC19 (dose 1)
- BIOLOGICAL IIV-HD + rC19 (dose 2)
- BIOLOGICAL IIV-HD + rC19 (dose 3)
Study Locations (12)
Texas
- Optimal Research, LLC Site Number : 8400002 — Austin
- Synexus Clinical Research US - Dallas- Site Number : 8400005 — Dallas
- Synexus Clinical Research US - San Antonio- Site Number : 8400009 — San Antonio
Alabama
- Simon Williamson Clinic - Birmingham- Site Number : 8400003 — Birmingham
- AES - DRS - Optimal Research Alabama - Huntsville Site Number : 8400006 — Huntsville
Arizona
- Orange Grove Family Practice- Site Number : 8400012 — Tucson
Florida
- Synexus Clinical Research US, Inc. - The Villages Site Number : 8400011 — The Villages
Georgia
- Synexus Clinical Research US - Atlanta- Site Number : 8400001 — Atlanta
Illinois
- Synexus Clinical Research- Site Number : 8400004 — Chicago
Missouri
- Synexus Clinical Research - St. Louis- Site Number : 8400010 — Creve Coeur
New York
- Synexus New York Site Number : 8400007 — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 980 participants |
| Start Date | 2024-11-19 |
| Est. Completion | 2026-04-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06695117
The ClinicalTrials.gov registry entry for NCT06695117 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 980 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 275 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Influenza Immunization appearing as the primary indexed condition, and to 5 interventions — of which IIV-HD is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06695117 reports 12 study locations spanning 9 distinct geographic areas — top geographies include Texas, Alabama, Arizona. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06695117 about?
NCT06695117 is a clinical study titled "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". Study VBT00001 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 IIV-HD (high-dose in...
What is the current status of trial NCT06695117?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 980 participants. The study started on 2024-11-19. Estimated completion is 2026-04-01.
What conditions does trial NCT06695117 study?
This clinical trial studies the following conditions: Influenza Immunization, COVID-19 Immunization. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06695117?
The interventions under investigation include: IIV-HD (BIOLOGICAL), rC19 (dose 1) (BIOLOGICAL), IIV-HD + rC19 (dose 1) (BIOLOGICAL), IIV-HD + rC19 (dose 2) (BIOLOGICAL), IIV-HD + rC19 (dose 3) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06695117?
This trial is sponsored by Sanofi, which has 275 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06695117 being conducted?
This trial has 12 study locations across Alabama, Arizona, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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