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NCT05608005 · ClinicalTrials.gov registry record · Phase 1
Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
A Phase 1 study of Healthy Volunteers and Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
- Completed
- Registry status
- Phase 1
- Development phase
- 581
- Enrollment target
- 16
- Study locations
NCT05608005: Completed Phase 1 study of Healthy Volunteers and Influenza, sponsored by Sanofi Pasteur, a Sanofi Company.
NCT05608005 is a Phase 1 study of Healthy Volunteers and Influenza that has completed, run by Sanofi Pasteur, a Sanofi Company. The registered enrollment target is 581 participants, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (21% higher). The trial reports 16 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05608005, a Phase 1 study of Healthy Volunteers and Influenza, has completed, sponsored by Sanofi Pasteur, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 581 participants
- Enrollment target
- 16
- Study locations
Study Summary
VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants in order to select one dose formulation to be used for further clinical development. The randomization ratio will be 3:3:1 for Panblok H7 (dose 1) + MF59, Panblok H7 (dose 2) + MF59, and Panblok H7 (dose 3) unadjuvanted, respectively. Each study group will be stratified into the age groups 18-64 years and ≥ 65 years of age. The study duration for each participant will be approximately 13 months.
Primary Outcome
The HAI antibody was measured by hemagglutination inhibition using horse red blood cells (HIH) measurement method. The 95% confidence interval (CI) was based on the Student t-distribution of log10-transformed values.
Conditions Studied
Interventions
- BIOLOGICAL Panblok + MF59 Dose 1
- BIOLOGICAL Panblok + MF59 Dose 2
- BIOLOGICAL Unadjuvanted Panblok Dose 3
Study Locations (16)
Florida
- Velocity Clinical Research-Hallandale Beach Site Number : 8400026 - Hallandale
- Research Centers of America Site Number : 8400024 - Hollywood
- Suncoast Research Associates, LLC Site Number : 8400008 - Miami
- St Johns Center for Clinical Research Site Number : 8400021 - Saint Augustine
Pennsylvania
- Preferred Primary Care Physicians Site Number : 8400015 - Pittsburgh
- Preferred Primary Care Physicians, Inc. Site Number : 8400002 - Pittsburgh
Utah
- JBR Clinical Research Site Number : 8400005 - Salt Lake City
- Foothill Family Research-South Site Number : 8400009 - Salt Lake City
Arizona
- Centricity Research-Mesa Site Number : 8400006 - Mesa
Georgia
- CenExel ACMR (Atlanta Center for Medical Research) Site Number : 8400022 - Atlanta
Indiana
- Velocity Clinical Research Valparaiso Site Number : 8400007 - Valparaiso
Louisiana
- Velocity Clinical Research Site Number : 8400027 - Metairie
North Carolina
- M3 Wake Research Inc Site Number : 8400010 - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 581 participants |
| Start Date | 2022-11-03 |
| Est. Completion | 2024-02-13 |
| Phase | Phase 1 |
What the finished NCT05608005 record still lists
NCT05608005 is an interventional study that assigns participants to a tested intervention. The registered 581 participants enrollment target is mid-sized for trials with a published cap, above the 480-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (21% higher).
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 3 interventions - of which Panblok + MF59 Dose 1 is the first listed.
NCT05608005 lists 16 locations in 11 states (Florida, Pennsylvania, Utah).
Frequently Asked Questions
What is clinical trial NCT05608005 about?
NCT05608005 is a clinical study titled "Study on Two Adjuvanted Dose Levels of Panblok H7+MF59 Compared for Immunogenicity and Safety With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older". VAM00001 is a Phase I/II, randomized, modified double-blind, multi-center study. The purpose of this study is to compare 2 dose levels of Panblok H7 (dose 1 and dose 2 of rHA) with a standard squalene dose of adjuvant MF59 to Panblok H7 (dose 3) unadjuvanted in approximately 700 adult participants ...
What is the current status of trial NCT05608005?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 581 participants. The study started on 2022-11-03. Estimated completion is 2024-02-13.
What conditions does trial NCT05608005 study?
This clinical trial studies the following conditions: Healthy Volunteers, Influenza.
What interventions are being tested in trial NCT05608005?
The interventions under investigation include: Panblok + MF59 Dose 1 (BIOLOGICAL), Panblok + MF59 Dose 2 (BIOLOGICAL), Unadjuvanted Panblok Dose 3 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05608005?
This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 153 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05608005 being conducted?
This trial has 16 study locations across Arizona, Florida, Georgia, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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581 27th of 283 higher than 257 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
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