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
Public ClinicalTrials.gov record NCT06695117. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1/2, Parallel, Randomized, Modified Double-blind, Multi-arm Study to Assess the Safety and Immunogenicity 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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06695117
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 980 participants
Conditions and interventions
Conditions
Interventions
- 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
- IIV-HD + rC19 (dose 4) Biological
- Placebo (0.9% NaCl) Other
Biological · Other
Eligibility (public fields only)
- Age range
- 50 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 18, 2024
- Primary completion
- Apr 15, 2026
- Completion
- Apr 15, 2026
- Last update posted
- May 4, 2026
2024 – 2026
United States locations
- U.S. sites
- 12
- U.S. states
- 9
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Simon Williamson Clinic - Birmingham- Site Number : 8400003 | Birmingham | Alabama | 35211 | — |
| AES - DRS - Optimal Research Alabama - Huntsville Site Number : 8400006 | Huntsville | Alabama | 35802-2568 | — |
| Orange Grove Family Practice- Site Number : 8400012 | Tucson | Arizona | 85741 | — |
| Synexus Clinical Research US - The Villages- Site Number : 8400011 | The Villages | Florida | 32162 | — |
| Synexus Clinical Research US - Atlanta- Site Number : 8400001 | Atlanta | Georgia | 30328 | — |
| Synexus Clinical Research- Site Number : 8400004 | Chicago | Illinois | 60602 | — |
| Synexus Clinical Research - St. Louis- Site Number : 8400010 | Creve Coeur | Missouri | 63141 | — |
| Synexus Clinical Research - New York- Site Number : 8400007 | New York | New York | 10017 | — |
| Optimal Research - Texas- Site Number : 8400002 | Austin | Texas | 78705 | — |
| Synexus Clinical Research US - Dallas- Site Number : 8400005 | Dallas | Texas | 75234 | — |
| Synexus Clinical Research US - San Antonio- Site Number : 8400009 | San Antonio | Texas | 78229 | — |
| Synexus Salt Lake City Site Number : 8400008 | Salt Lake City | Utah | 84106 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06695117, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 4, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06695117 live on ClinicalTrials.gov.