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

PHASE2CompletedINTERVENTIONAL
Enrollment

1,001

Participants

Timeline

Start Date

April 30, 2016

Primary Completion Date

July 31, 2016

Study Completion Date

January 31, 2017

Conditions
Virus DiseasesRNA Virus InfectionsRespiratory Tract DiseasesRespiratory 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

Trial Locations (15)

13760

Regional Clinical Research (RCR), Endwell

31406

Meridian Clinical Research - Savannah, Savannah

33024

Broward Research Group (BRG), Hollywood

33143

Miami Research Associates (MRA), South Miami

68134

Meridian Clinical Research - Omaha, Omaha

96001

Paradigm Research - Redding, Redding

M5V 2T3

INC Research Toronto, Toronto

M9C 4Z5

Topstone Research, Toronto

G6W OM5

Manna Research, Lévis

J7J 2K8

Omnispec Clinical Research, Mirabel

H2Y 1S1

Diex Research Montreal, Montreal

H9H 4Y6

McGill University Health Center - Vaccine Study Center (MUHC), Pierrefonds

J1H 1Z1

Diex Research Sherbroooke, Sherbroooke

G1E 7G9

Équipe de recherche en vaccination du CHU de Québec-Université Laval (CHU), Québec

G1W 4R4

Centre de Recherche St-Louis, Québec

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Medicago

INDUSTRY

NCT02831751 - Immunogenicity, Safety, and Tolerability of a Plant-Derived Quadrivalent VLP Influenza Vaccine in Elderly Adults | Biotech Hunter | Biotech Hunter