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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00354861 | A Randomized Phase I Study of a Hepatitis B Antigen Combined With IMP321 | PHASE1 | COMPLETED | 48 | — | — | May 1, 2005 | Feb 1, 2006 | Apr 25, 2008 | 1 | France |
| Arm | Type | Description |
|---|---|---|
| A | EXPERIMENTAL | IMP321 |
| B | PLACEBO_COMPARATOR | Saline |
| C | ACTIVE_COMPARATOR | Engerix B |
| Name | Type | Description |
|---|---|---|
| hepatitis B antigen (without alum) plus IMP321 | BIOLOGICAL | hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with IMP321 |
| hepatitis B antigen alone (without alum) | BIOLOGICAL | hepatitis B antigen (10 µg HbsAg, subtype adw, without alum) with physiological saline |
| Engerix B | BIOLOGICAL | 20 µg hepatitis B antigen absorbed on alum |
Inclusion Criteria: * able to give a written informed consent ; * healthy male volunteers aged between 18 and 40 years and post-menopausal healthy women aged between 18 and 55 years; * with body mass index (weight/height²) in the range 18 to 30 kg/m²; * registered with the French Social Security in...