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Safety Study of a Plant-based H5 Virus-Like Particles (VLP) Vaccine in Healthy Adults

NCT00984945 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2010-11-04

No results posted yet for this study

Summary

The primary objective is to assess the safety and tolerability of two consecutive doses of plant-based H5 VLP, (H5N1) pandemic influenza vaccine combined with Alhydrogel®, given 21 days apart, at three dose levels: 5µg, 10µg and 20µg., compared to the placebo, and combined with Alhydrogel®.

Conditions

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

Interventions

BIOLOGICAL

H5 VLP pandemic influenza vaccine 5 µg

0.5 mL, IM, 2 injections 21 days apart

BIOLOGICAL

H5 VLP pandemic influenza vaccine 10 µg

0.5 mL, IM, 2 injections 21 days apart

BIOLOGICAL

H5 VLP pandemic influenza vaccine 20 µg

0.5 mL, IM, two injections 21 days apart

BIOLOGICAL

Placebo

0.5 mL, IM, two injections 21 days apart

Sponsors & Collaborators

  • Medicago

    lead INDUSTRY

Principal Investigators

  • Brian Ward, MD · MUHC Vaccine Study Centre

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-12-31
Completion
2010-07-31

Countries

  • Canada

Study Locations

More Related Trials

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 NCT00984945 on ClinicalTrials.gov