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Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.

NCT01991561 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 390

Last updated 2020-06-11

No results posted yet for this study

Summary

A phase 2, Randomized, Observer-blind, Multicenter, Dose-Ranging Study to Evaluate the Immunogenicity, Safety, and Tolerability of the plant-made H5 VLP Influenza vaccine adjuvanted with Alhydrogel or Glucopyranosyl-lipid adjuvant in squalene emulsion (GLA-SE), in healthy adults 18-60 years of age.

Conditions

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

Interventions

BIOLOGICAL

Low dose of H5 VLP vaccine + Alhydrogel

Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

Med dose of H5 VLP vaccine + Alhydrogel

Biological:Med dose of H5 VLP vaccine 2 doses given 21 days apart of Med dose H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

High dose of H5 VLP vaccine + Alhydrogel

Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

Low dose of H5 VLP vaccine + GLA-SE

Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with GLA-SE

BIOLOGICAL

High dose of H5 VLP vaccine + GLA-SE

Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with GLA-SE

BIOLOGICAL

Placebo comparator: Placebo

Biological: Placebo 2 doses given 21 days apart of the placebo

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Medicago

    lead INDUSTRY

Principal Investigators

  • Michael Libman, MD · MUHC-Vaccine Study Centre

  • Luis Robles, MD · Syneos Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-07-31
Completion
2014-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

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 NCT01991561 on ClinicalTrials.gov