Immunogenicity, Safety, Tolerability of a Plant-made H5 Virus-like-particle (VLP) Influenza Vaccine.

PHASE2CompletedINTERVENTIONAL
Enrollment

390

Participants

Timeline

Start Date

June 30, 2013

Primary Completion Date

July 31, 2014

Study Completion Date

November 30, 2014

Conditions
Virus DiseasesRNA Virus InfectionsRespiratory Tract DiseasesRespiratory Tract Infections
Interventions
BIOLOGICAL

Low dose of H5 VLP vaccine + Alhydrogel

Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

Med dose of H5 VLP vaccine + Alhydrogel

Biological:Med dose of H5 VLP vaccine 2 doses given 21 days apart of Med dose H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

High dose of H5 VLP vaccine + Alhydrogel

Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

Low dose of H5 VLP vaccine + GLA-SE

Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with GLA-SE

BIOLOGICAL

High dose of H5 VLP vaccine + GLA-SE

Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with GLA-SE

BIOLOGICAL

Placebo comparator: Placebo

Biological: Placebo 2 doses given 21 days apart of the placebo

Trial Locations (2)

M5V2T3

INC Research, Toronto

H9H4Y6

MUHC Vaccine Study Center, Pierrefonds

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

lead

Medicago

INDUSTRY