Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen

PHASE1CompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

April 30, 2005

Primary Completion Date

September 30, 2005

Study Completion Date

February 28, 2006

Conditions
Healthy
Interventions
BIOLOGICAL

IMP321

This study is a single centre, single blind, placebo (step 1) or reference (step 2) randomised study. Healthy young male volunteers will receive single ascending dose of IMP321 in each step (4 doses tested: 3, 10, 30 and 100 µg). In step 1, IMP321 will be given alone and tested versus placebo (physiological saline). In step 2, the association IMP321 + Agrippal (commercially available flu vaccine) will be tested versus Agrippal alone.

BIOLOGICAL

saline

saline injected alone in step 1 or mixed with Aggripal in step 2

Trial Locations (1)

75015

SGS Aster-Cephac, Paris

All Listed Sponsors
collaborator

SGS Aster-Cephac (CRO)

UNKNOWN

lead

Immutep S.A.S.

INDUSTRY

NCT00354263 - Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen | Biotech Hunter | Biotech Hunter