NCT05608005

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 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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 581 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

The study duration for each participant will be approximately 13 months.

Conditions

• Influenza
• Healthy Volunteers

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-11-03
• Primary completion: 2023-02-18
• Completion: 2024-02-13
• First posted: 2022-11-07
• Last updated: 2025-09-24
• Results posted: 2025-02-20

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study