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

NCT00354263 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2008-04-24

No results posted yet for this study

Summary

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.

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

Sponsors & Collaborators

  • SGS Aster-Cephac (CRO)

    collaborator UNKNOWN

  • Immutep S.A.S.

    lead INDUSTRY

Principal Investigators

  • Didier Chassard, M.D. · Aster-Cephac

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2005-09-30
Completion
2006-02-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00354263 on ClinicalTrials.gov