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Phase 1 Evaluation of H1 Influenza Vaccine Delivered by MIMIX MAP

NCT06125717 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2023-11-09

No results posted yet for this study

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

Interventions

BIOLOGICAL

H1 influenza antigen

Either 7.5 μg or 15 μg of the H1 influenza antigen

Sponsors & Collaborators

  • ICON plc

    collaborator INDUSTRY

  • Q2 Solutions

    collaborator INDUSTRY

  • Centricity Research

    collaborator UNKNOWN

  • Vaxess Technologies

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
39 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-02
Primary Completion
2023-03-13
Completion
2023-03-13

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT06125717 on ClinicalTrials.gov