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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 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 581

Last updated 2025-09-24

Study results available
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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.

Conditions

Interventions

BIOLOGICAL

Panblok + MF59 Dose 1

Pharmaceutical form: suspension for injection Route of administration: intramuscular

BIOLOGICAL

Panblok + MF59 Dose 2

Pharmaceutical form: suspension for injection Route of administration: intramuscular

BIOLOGICAL

Unadjuvanted Panblok Dose 3

Pharmaceutical form: liquid for injection Route of administration: intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · MCM Vaccines B.V.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-03
Primary Completion
2023-02-18
Completion
2024-02-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05608005 on ClinicalTrials.gov