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NCT06727058 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older
A Phase 1 study of Influenza Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
- Active
- Registry status
- Phase 1
- Development phase
- 276
- Enrollment target
- 14
- Study locations
NCT06727058: Active Phase 1 study of Influenza Immunization, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT06727058 is a Phase 1 study of Influenza Immunization that is active but no longer recruiting, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 276 participants, below the 683-participant average among 3 other Influenza Immunization trials with a reported enrollment target (60% lower). The trial reports 14 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06727058, a Phase 1 study of Influenza Immunization, is active but no longer recruiting, sponsored by Sanofi Pasteur, a Sanofi Company.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 276 participants
- Enrollment target
- 14
- Study locations
Study Summary
The purpose of this study is to evaluate a pandemic flu H5 strain messenger ribonucleic acid (mRNA) vaccine at 3 dose levels (low, medium, and high) in comparison with placebo in 276 healthy adult participants to select the adequate dose for further clinical development. The duration per participant will be approximately 13 months.
Primary Outcome
Number of participants experiencing immediate AEs
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Pandemic flu H5 mRNA vaccine
Study Locations (14)
Florida
- Accel Research Sites Network - DeLand Clinical Research Unit- Site Number : 8400002 - DeLand
- ARSN-Lakeland CRU- Site Number : 8400006 - Lakeland
- Accel Research Sites - St. Petersburg- Site Number : 8400004 - Largo
Georgia
- Atlanta Clinical Research Center- Site Number : 8400007 - Atlanta
- Accel Research Site - NeuroStudies.net, LLC - ERN - PPDS- Site Number : 8400003 - Decatur
Nebraska
- Velocity Clinical Research - Norfolk- Site Number : 8400015 - Norfolk
- Velocity Clinical Research - Omaha- Site Number : 8400012 - Omaha
California
- Velocity Clinical Research - San Diego- Site Number : 8400013 - La Mesa
Michigan
- QUEST Research Institute- Site Number : 8400014 - Bingham Farms
Ohio
- Velocity Clinical Research - Springdale- Site Number : 8400010 - Cincinnati
South Carolina
- Coastal Carolina Research Center - North Charleston- Site Number : 8400001 - North Charleston
Texas
- Olympus Clinical Research - Sugar Land- Site Number : 8400009 - Sugar Land
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 276 participants |
| Start Date | 2024-12-09 |
| Est. Completion | 2026-03-31 |
| Phase | Phase 1 |
What the registry record for NCT06727058 still lists
NCT06727058 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, below the 683-participant average among 3 other Influenza Immunization trials with a reported enrollment target (60% lower).
The record links to 1 condition, with Influenza Immunization appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06727058 lists 14 locations in 10 states (Florida, Georgia, Nebraska).
Frequently Asked Questions
What is clinical trial NCT06727058 about?
NCT06727058 is a clinical study titled "Study to Evaluate Safety and Immunogenicity of a Pandemic Flu H5 mRNA Vaccine in Healthy Adults Aged 18 Years and Older". The purpose of this study is to evaluate a pandemic flu H5 strain messenger ribonucleic acid (mRNA) vaccine at 3 dose levels (low, medium, and high) in comparison with placebo in 276 healthy adult participants to select the adequate dose for further clinical development. The duration per participan...
What is the current status of trial NCT06727058?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 276 participants. The study started on 2024-12-09. Estimated completion is 2026-03-31.
What conditions does trial NCT06727058 study?
This clinical trial studies the following conditions: Influenza Immunization.
What interventions are being tested in trial NCT06727058?
The interventions under investigation include: Placebo (OTHER), Pandemic flu H5 mRNA vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT06727058?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06727058 being conducted?
This trial has 14 study locations across California, Florida, Georgia, Michigan, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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