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NCT06695130 · 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 Recombinant 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
NCT06695130: Active Phase 1 study of Influenza Immunization and COVID-19 Immunization, sponsored by Sanofi.
NCT06695130 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 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06695130, 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 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.
Primary Outcome
Within the 30 minutes after vaccination
Conditions Studied
Interventions
- BIOLOGICAL rC19 (dose 1)
- BIOLOGICAL RIV (recombinant influenza vaccine)
- BIOLOGICAL RIV + rC19 (dose 1)
- BIOLOGICAL RIV + rC19 (dose 2)
- BIOLOGICAL RIV + rC19 (dose 3)
Study Locations (12)
California
- Synexus Clinical Research US, Inc. - Cerritos- Site Number : 8400002 - Cerritos
- Synexus Clinical Research US - Vista- Site Number : 8400010 - Vista
Florida
- Optimal Research - Florida- Site Number : 8400006 - Melbourne
- Synexus Clinical Research US - Orlando- Site Number : 8400007 - Orlando
Arizona
- Central Phoenix Medical Clinic- Site Number : 8400009 - Phoenix
Illinois
- Optimal Research - Illinois- Site Number : 8400008 - Peoria
Indiana
- Synexus Clinical Research US - Evansville- Site Number : 8400004 - Evansville
Massachusetts
- Walgreens Clinical Trials-Malden- Site Number : 8400012 - Malden
Minnesota
- Synexus Clinical Research US - Minneapolis- Site Number : 8400011 - Richfield
Nevada
- Synexus-Las Vegas- Site Number : 8400005 - Las Vegas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 980 participants |
| Start Date | 2024-11-18 |
| Est. Completion | 2026-04-03 |
| Phase | Phase 1 |
What the registry record for NCT06695130 still lists
NCT06695130 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 rC19 (dose 1) is the first listed.
NCT06695130 lists 12 locations in 10 states (California, Florida, Arizona).
Frequently Asked Questions
What is clinical trial NCT06695130 about?
NCT06695130 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 Recombinant Influenza Vaccine in Adult Participants 50 Years of Age and Older". 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...
What is the current status of trial NCT06695130?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 980 participants. The study started on 2024-11-18. Estimated completion is 2026-04-03.
What conditions does trial NCT06695130 study?
This clinical trial studies the following conditions: Influenza Immunization, COVID-19 Immunization.
What interventions are being tested in trial NCT06695130?
The interventions under investigation include: rC19 (dose 1) (BIOLOGICAL), RIV (recombinant influenza vaccine) (BIOLOGICAL), RIV + rC19 (dose 1) (BIOLOGICAL), RIV + rC19 (dose 2) (BIOLOGICAL), RIV + rC19 (dose 3) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06695130?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06695130 being conducted?
This trial has 12 study locations across Arizona, California, Florida, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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