Immunogenicity of a Quadrivalent Virus-Like Particles (VLP) Influenza Vaccine in Healthy Adults

Summary

This Phase 2 Quadrivalent VLP Vaccine study is intended to replicate and extend the immunogenicity and safety results obtained in earlier Phase 1-2 and Phase 2 studies. The study is being conducted to demonstrate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria. The study will also help to define the optimal dose, establish potential competitive advantages, and support the design of future studies.

Conditions

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

Interventions

BIOLOGICAL

15 µg/strain of Quadrivalent VLP Vaccine

Single dose of non-adjuvanted Quadrivalent VLP Vaccine

BIOLOGICAL

30 µg/strain of Quadrivalent VLP Vaccine

Single dose of non-adjuvanted Quadrivalent VLP Vaccine

BIOLOGICAL

15 µg/strain of the licensed quadrivalent vaccine

Single dose of the licensed quadrivalent vaccine

Sponsors & Collaborators

• Medicago

  lead INDUSTRY

Principal Investigators

• Pierre Lachance, MD · Centre de Recherche St-Louis, Quebec, Canada

• Marc Dionne, MD · Équipe de recherche en vaccination du CHU de Québec-Université Laval (CHU), Quebec, Canada

• Michael Libman, MD · McGill University Health Center - Vaccine Study Center (MUHC), Montreal, Canada

• Trevor Wesson, MD · Diex Research Montreal, Montreal, Canada

• Ginette Girard, MD · Diex Research Sherbrooke, Sherbrooke, Canada

• Deepen Patel, MD · Topstone Research, Toronto, Canada

• Diane Krieger, MD · Miami Research Associates (MRA), Miami (FL), USA

• David Seiden, MD · Broward Research Group (BRG), Hollywood (FL), USA

• Suchet R Patel, MD · Regional Clinical Research (RCR), Endwell (NY), USA

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-03-02

Primary Completion

2016-05-17

Completion

2016-11-26

Countries

• United States
• Canada

Study Locations