Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Elderly 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 evaluate that the immunogenicity profile of the Quadrivalent VLP Vaccine meets the US Center for Biologics Evaluation and Research (CBER) licensure criteria and to evaluate if the immunogenicity and the safety profile of the Quadrivalent VLP Vaccine is acceptable and comparable to that of the FluLaval® Tetra and Fluzone® High-Dose (HD). The study will also help to define the optimal dose in this population, 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

30 µg/strain of Quadrivalent VLP Vaccine

Single dose of non-adjuvanted Quadrivalent VLP Vaccine

BIOLOGICAL

60 µg/strain of Quadrivalent VLP Vaccine

Single dose of non-adjuvanted Quadrivalent VLP Vaccine

BIOLOGICAL

FluLaval® Tetra (15 µg/strain)

Single dose of a licensed quadrivalent vaccine

BIOLOGICAL

Fluzone® High-Dose (60 µg/strain)

Single dose of a licensed trivalent vaccine

Sponsors & Collaborators

• Medicago

  lead INDUSTRY

Principal Investigators

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

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

• Gérald Vallières, MD · Manna Research, Lévis, Canada

• Luis Robles, MD · INC Research Toronto, Inc., Toronto, Canada

• Guy Tellier, MD · Omnispec Clinical Research Inc, Mirabel, Canada

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

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

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

• Paul Bradley, MD · Meridian Clinical Research, Savannah (GA), USA

• Brandon J Essink, MD · Meridian Clinical Research, Omaha (NE), USA

• Jamshid Saleh, MD · Paradigm Research, Redding (CA), USA

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-04-30

Primary Completion

2016-07-31

Completion

2017-01-31

Countries

• United States
• Canada

Study Locations