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Safety, Tolerability and Immunogenicity of a Plant-made Seasonal Quadrivalent VLP Influenza Vaccine in Adults

NCT01991587 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-06-11

No results posted yet for this study

Summary

A phase I/II trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of a single intramuscular injection of plant-based Seasonal Quadrivalent VLP Influenza Vaccine administered to healthy adults 18-49 years of age.

A total of one hundred and twenty (120) subjects will be randomized in four (4) groups of 30 subjects to receive one injection of either a low, a medium, or a high dose level of VLP of the quadrivalent VLP influenza vaccine or the placebo preparation (100 millimolar (mM) phosphate buffer + 150 mM sodium chloride (NaCl) + 0.01% Tween 80).

Conditions

  • Virus Diseases
  • RNA Virus Infections
  • Respiratory Tract Diseases
  • Respiratory Tract Infections

Interventions

BIOLOGICAL

Low dose of quadrivalent VLP vaccine

A single low dose of quadrivalent VLP vaccine

BIOLOGICAL

Medium dose of quadrivalent VLP vaccine

A single medium dose of quadrivalent VLP vaccine

BIOLOGICAL

High dose of quadrivalent VLP vaccine

A single high dose of quadrivalent VLP vaccine

BIOLOGICAL

Placebo

A single dose of placebo

Sponsors & Collaborators

  • Medicago

    lead INDUSTRY

Principal Investigators

  • Eric Sheldon, MD · Miami Research Associate

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-10-08
Primary Completion
2014-06-30
Completion
2014-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT01991587 on ClinicalTrials.gov