Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00354263 | Phase I Study of IMP321 Given Alone or as an Adjuvant to a Reference Flu Antigen | PHASE1 | COMPLETED | 60 | — | — | Apr 1, 2005 | Feb 1, 2006 | Apr 24, 2008 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| A | PLACEBO_COMPARATOR | PBS injected alone in step 1 or mixed with Aggripal in step 2 |
| B | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| IMP321 | BIOLOGICAL | 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. |
| saline | BIOLOGICAL | saline injected alone in step 1 or mixed with Aggripal in step 2 |
Inclusion Criteria: * able to give a written informed consent ; * healthy male volunteers aged between 18 and 40 years; * with body mass index (weight/height²) in the range 18 to 30 kg/m²; * registered with the French Social Security in agreement with the French Law (Huriet Law : N° 88.1138 - 20.12...