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COMPLETED 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

NCT05608005 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 581 participants
Start Date 2022-11-03
Est. Completion 2024-02-13
Phase Phase 1

Sponsor

Sanofi Pasteur, a Sanofi Company

43 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05608005

The ClinicalTrials.gov registry entry for NCT05608005 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 581 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi Pasteur, a Sanofi Company, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05608005 reports 16 study locations spanning 11 distinct geographic areas — top geographies include Florida, Pennsylvania, Utah. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05608005?

This trial is sponsored by Sanofi Pasteur, a Sanofi Company, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial