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
Public ClinicalTrials.gov record NCT05608005. 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 Parallel-group, Phase I/II, Randomized, Modified Double-blind, 3-arm, Active Comparator, Multi-center, Prevention Study to Evaluate the Immunogenicity and Safety of Two Adjuvanted Dose Levels of Panblok H7+MF59 Influenza Vaccine Compared With an Unadjuvanted Dose of Panblok H7 in Participants 18 Years of Age and Older
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05608005
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 581 participants
Conditions and interventions
Conditions
Interventions
- Panblok + MF59 Dose 1 Biological
- Panblok + MF59 Dose 2 Biological
- Unadjuvanted Panblok Dose 3 Biological
Biological
Eligibility (public fields only)
- Age range
- 18 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 2, 2022
- Primary completion
- Feb 17, 2023
- Completion
- Feb 12, 2024
- Last update posted
- Sep 23, 2025
2022 – 2024
United States locations
- U.S. sites
- 16
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Centricity Research-Mesa Site Number : 8400006 | Mesa | Arizona | 85206 | — |
| Velocity Clinical Research-Hallandale Beach Site Number : 8400026 | Hallandale | Florida | 33009 | — |
| Research Centers of America Site Number : 8400024 | Hollywood | Florida | 33024 | — |
| Suncoast Research Associates, LLC Site Number : 8400008 | Miami | Florida | 33173 | — |
| St Johns Center for Clinical Research Site Number : 8400021 | Saint Augustine | Florida | 32086 | — |
| CenExel ACMR (Atlanta Center for Medical Research) Site Number : 8400022 | Atlanta | Georgia | 30331 | — |
| Velocity Clinical Research Valparaiso Site Number : 8400007 | Valparaiso | Indiana | 46383 | — |
| Velocity Clinical Research Site Number : 8400027 | Metairie | Louisiana | 70006 | — |
| M3 Wake Research Inc Site Number : 8400010 | Raleigh | North Carolina | 27612 | — |
| Preferred Primary Care Physicians Site Number : 8400015 | Pittsburgh | Pennsylvania | 15236 | — |
| Preferred Primary Care Physicians, Inc. Site Number : 8400002 | Pittsburgh | Pennsylvania | 15243 | — |
| Velocity Clinical Research Anderson Site Number : 8400016 | Anderson | South Carolina | 29621 | — |
| WR-ClinSearch, LLC Site Number : 8400003 | Chattanooga | Tennessee | 37421 | — |
| Velocity Clinical Research Site Number : 8400019 | Austin | Texas | 78759 | — |
| JBR Clinical Research Site Number : 8400005 | Salt Lake City | Utah | 84107 | — |
| Foothill Family Research-South Site Number : 8400009 | Salt Lake City | Utah | 84121 | — |
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 NCT05608005, 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 Sep 23, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05608005 live on ClinicalTrials.gov.