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NCT06695117 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Influenza Immunization and COVID-19 Immunization, sponsored by Sanofi.
- Active
- Registry status
- Phase 1
- Development phase
- 980
- Enrollment target
- 12
- Study locations
NCT06695117: Active Phase 1 study of Influenza Immunization and COVID-19 Immunization, sponsored by Sanofi.
NCT06695117 is a Phase 1 study of Influenza Immunization and COVID-19 Immunization that is active but no longer recruiting, run by Sanofi. The registered enrollment target is 980 participants, above the 449-participant average among 3 other Influenza Immunization trials with a reported enrollment target (118% higher). The trial reports 12 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06695117, a Phase 1 study of Influenza Immunization and COVID-19 Immunization, is active but no longer recruiting, sponsored by Sanofi.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 980 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
Immediate adverse events are any unsolicited systemic adverse events reported in the 30 minutes after vaccination
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 |
What the registry record for NCT06695117 still lists
NCT06695117 is an interventional study that assigns participants to a tested intervention. The registered 980 participants enrollment target is mid-sized for trials with a published cap, above the 449-participant average among 3 other Influenza Immunization trials with a reported enrollment target (118% higher).
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.
NCT06695117 lists 12 locations in 9 states (Texas, Alabama, Arizona).
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.
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).
Who is sponsoring clinical trial NCT06695117?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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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