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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00876252 | Study Assessing Immunogenicity and Safety of IC43 In Intensive Care Patients | PHASE2 | COMPLETED | 400 | — | — | Dec 1, 2008 | Feb 1, 2010 | Oct 19, 2012 | 1 | Austria |
| Arm | Type | Description |
|---|---|---|
| IC43 100 mcg | ACTIVE_COMPARATOR | IC43 100 mcg with Aluminum hydroxide |
| IC43 200 mcg | ACTIVE_COMPARATOR | IC43 200 mcg with Aluminum hydroxide |
| IC43 100 mcg w/o | ACTIVE_COMPARATOR | IC43 100 mcg without Aluminum hydroxide |
| Placebo | PLACEBO_COMPARATOR | phosphate-buffered saline solution containing 0,9 % NaCl and 400 mcg Aluminum hydroxide as an adjuvant |
| Name | Type | Description |
|---|---|---|
| IC43 | BIOLOGICAL | - |
| Placebo | DRUG | NaCl |
Inclusion Criteria: * Male or female patients aged between 18 and 80 years * Patients admitted to an ICU with a need for mechanical ventilation for more than 48 hours at visit 0 * At high risk for acquiring infection against P. aeruginosa at visit 0. * Patients who, as determined by the investigato...