Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IC43 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| IC43 100 mcg | ACTIVE_COMPARATOR | IC43 100 mcg intramuscular injection, IC43 is a recombinant Pseudomonas aeruginosa fusion protein |
| Placebo | PLACEBO_COMPARATOR | phosphate buffered saline solution containing 0,9 % NaCL |
| IC43 200 mcg | ACTIVE_COMPARATOR | IC43 200 mcg with Aluminum hydroxide |
| IC43 100 mcg w/o | ACTIVE_COMPARATOR | IC43 100 mcg without Aluminum hydroxide |
| IC43 50 | ACTIVE_COMPARATOR | IC43 50 mcg with AI(OH)3 |
| IC43 100 with | ACTIVE_COMPARATOR | IC43 100 mcg with AI(OH)3 |
| IC43 100 w/o | ACTIVE_COMPARATOR | IC43 100 mcg w/o AI(OH)3 |
| IC43 200 | ACTIVE_COMPARATOR | IC43 200 mcg with AI(OH)3 |
| Name | Type | Description |
|---|---|---|
| IC43 | BIOLOGICAL | 100 mcg |
| Placebo | DRUG | phosphate buffered saline (PBS) solution containing 0,9 % NaCl |
Inclusion Criteria: * male or female patients admitted to an intensive care unit (ICU) with need for mechanical ventilation for at least 48 hours, aged between 18 and 80 years at Visit 0 * written informed consent or waiver according to the national regulations * no childbearing potential or negati...
IC43 is an investigational vaccine being studied for the prevention of Pseudomonas aeruginosa infection, including ventilator-associated pneumonia. It is also being evaluated in healthy volunteers to assess its safety and immunogenicity. The drug is still in clinical development and has not been approved by regulatory authorities.
IC43 is being developed by Valneva SE, a biopharmaceutical company listed on the stock exchange under the ticker VALN. Valneva is conducting clinical trials to evaluate the safety, immunogenicity, and efficacy of IC43 in various patient populations.
IC43 is in Phase 1 clinical development. The earliest trial, NCT00778388, was a Phase 1 study in healthy volunteers. Subsequent trials, including NCT00876252 and NCT01563263, were Phase 2 studies. All trials listed are completed, and IC43 remains an investigational drug.
IC43 has been studied in three completed clinical trials. NCT00778388 was a Phase 1 study in healthy volunteers in Austria and Germany. NCT00876252 was a Phase 2 study in intensive care patients with ventilator-associated pneumonia in Austria. NCT01563263 was a Phase 2 study in patients with Pseudomonas aeruginosa infection across multiple European countries.
IC43 is the primary name for this investigational vaccine. No alternative names have been reported for this drug in the available clinical trial data. It is being developed specifically for Pseudomonas aeruginosa infections and is not known to be marketed under any other brand name.