Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Heat-Labile Enterotoxin of Escherichia coli · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Group 1 | ACTIVE_COMPARATOR | Group 1 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 37.5µg LT |
| Group 2 | PLACEBO_COMPARATOR | Group 2 subjects will receive two vaccinations via transcutaneous immunization (TCI), 14 to 21 days apart, with a patch containing 0µg LT (placebo patch containing no LT) |
| Name | Type | Description |
|---|---|---|
| Heat-Labile Enterotoxin of Escherichia coli (LT) | BIOLOGICAL | Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart. |
| Placebo | BIOLOGICAL | The placebo patch contains all of the components of the active patch, but with no LT included in the formulation. |
Inclusion Criteria: * Healthy adult men and women 18-64 years of age inclusive at screening * Signed Informed Consent form * Planned travel to an area within 2 ½ hours traveling distance of Cuernavaca or Guadalajara, Mexico or Antigua, Guatemala (minimum stay of 7 days) * If female who is not post-...
Heat-Labile Enterotoxin of Escherichia coli is an investigational drug being studied for the prevention of diarrhea. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Heat-Labile Enterotoxin of Escherichia coli is being developed by Valneva SE, a biopharmaceutical company. Valneva trades on the stock exchange under the ticker symbol VALN.
Heat-Labile Enterotoxin of Escherichia coli is in Phase 2 clinical development. It is an investigational drug and has not yet been approved for commercial use. The drug is being studied for the prevention of diarrhea.
Heat-Labile Enterotoxin of Escherichia coli has one completed Phase 2 clinical trial, identified as NCT00516659, titled "ETEC Logistics Trial (TREK)". This trial enrolled 201 participants and was conducted in the United States, Guatemala, and Mexico.
Heat-Labile Enterotoxin of Escherichia coli is a drug candidate being developed to prevent diarrhea caused by enterotoxigenic Escherichia coli (ETEC). The clinical trial NCT00516659 is titled "ETEC Logistics Trial (TREK)", indicating its focus on ETEC-related diarrhea.