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Safety, Tolerability and Immunogenicity of a Plant-made H7 Virus-like Particle (VLP) Influenza Vaccine in Adults.

NCT02022163 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2015-09-25

No results posted yet for this study

Summary

A phase I trial conducted in a single centre, observer-blind, randomized, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and immunogenicity of 2 intramuscular injections of plant-based H7 VLP Influenza Vaccine administered to healthy adults, 18-60 years of age.

Conditions

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

Interventions

BIOLOGICAL

Low dose of H7 VLP vaccine + Alhydrogel

Low dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart

BIOLOGICAL

Med dose of H7 VLP vaccine + Alhydrogel

Med dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart

BIOLOGICAL

High dose of H7 VLP vaccine + Alhydrogel

High dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart

BIOLOGICAL

High dose of H7 VLP vaccine

High dose of H7 VLP vaccine, 2 doses given 21 days apart

BIOLOGICAL

Placebo

Placebo, 2 doses given 21 days apart

Sponsors & Collaborators

  • Health Sciences Centre, Winnipeg, Manitoba

    collaborator OTHER

  • Public Health Agency of Canada (PHAC)

    collaborator OTHER_GOV

  • Syneos Health

    collaborator OTHER

  • Medicago

    lead INDUSTRY

Principal Investigators

  • Neil Simonsen, MD · Canadian Science Centre for Human and Animal 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
2013-12-31
Primary Completion
2014-09-30
Completion
2014-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
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 NCT02022163 on ClinicalTrials.gov