NCT06125717

Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

A Phase 1, Randomized, Rater and Subject Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Vaxess Technologies · Industry
• Sex: All
• Age: 18 Years – 39 Years
• Healthy volunteers: Accepted

Summary

A Phase 1, Randomized, Rater and Participant Blinded Placebo Controlled Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of a Standard and a Fractional Dose of H1 Influenza Vaccine Delivered by VX-103 (a MIMIX Microneedle Array Patch (MAP) System) in Healthy Adults ≥18-39 Years of Age

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	H1 influenza antigen	Either 7.5 μg or 15 μg of the H1 influenza antigen

Timeline

• Start date: 2022-07-02
• Primary completion: 2023-03-13
• Completion: 2023-03-13
• First posted: 2023-11-09
• Last updated: 2023-11-09

Locations

3 sites across 1 country: Canada