Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine

PHASE2CompletedINTERVENTIONAL
Enrollment

255

Participants

Timeline

Start Date

November 30, 2010

Primary Completion Date

July 31, 2011

Study Completion Date

September 30, 2011

Conditions
Virus DiseasesRNA Virus InfectionsRespiratory Tract DiseasesRespiratory Tract Infections
Interventions
BIOLOGICAL

20 micrograms dose H5 VLP

2 doses given 21 days apart of 20 micrograms of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

30 micrograms dose H5 VLP

2 doses given 21 days apart of 30 micrograms of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

45 micrograms dose H5 VLP

2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine mixed with Alhydrogel

BIOLOGICAL

45 micrograms non-adjuvanted H5 VLP

2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine

BIOLOGICAL

Placebo

2 doses given 21 days apart of the placebo

Trial Locations (1)

M5V 2T3

Kendle Early Stage, Toronto

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Medicago

INDUSTRY

NCT01244867 - Immunogenicity, Safety, Tolerability of a Plant-Made H5 VLP Influenza Vaccine | Biotech Hunter | Biotech Hunter