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Immunogenicity, Safety and Tolerability of a Plant-Derived Seasonal VLP Quadrivalent Influenza Vaccine in the Elderly Population

NCT02236052 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2019-11-01

No results posted yet for this study

Summary

This is a multiple sites phase II trial, randomized, observer-blind, dose ranging, placebo-controlled study to evaluate the immunogenicity, safety, and tolerability of a single intramuscular injection of plant-based Seasonal VLP Quadrivalent Influenza Vaccine administered in elderly subjects (50 years old and more).

A total of four hundred fifty (450) subjects will be randomized in six (6) groups of 75 subjects to receive one injection of either a non-adjuvanted low, medium or high dose level of VLP, a low or high dose level of VLP of the quadrivalent VLP influenza vaccine combined with Alhydrogel® as adjuvant 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

Non-adjuvanted low dose of quadrivalent VLP vaccine

A single non-adjuvanted low dose of quadrivalent VLP vaccine

BIOLOGICAL

Non-adjuvanted medium dose of quadrivalent VLP vaccine

A single non-adjuvanted medium dose of quadrivalent VLP vaccine

BIOLOGICAL

Non-adjuvanted high dose of quadrivalent VLP vaccine

A single non-adjuvanted high dose of quadrivalent VLP vaccine

BIOLOGICAL

Adjuvanted low dose of quadrivalent VLP vaccine

A single low dose of quadrivalent VLP vaccine mixed with Alhydrogel®

BIOLOGICAL

Adjuvanted high dose of quadrivalent VLP vaccine

A single high dose of quadrivalent VLP vaccine mixed with Alhydrogel®

BIOLOGICAL

Placebo

A single dose of placebo

Sponsors & Collaborators

  • Medicago

    lead INDUSTRY

Principal Investigators

  • Michael Libman, MD · MUHC-Vaccine Study Centre

  • Guy Boivin, MD · Centre de recherche-CHU de Québec

  • Richard Larouche, MD · inVentiv Health Clinique

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-07-16
Primary Completion
2015-06-17
Completion
2015-06-17

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 NCT02236052 on ClinicalTrials.gov