Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TD Vaccine System · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | 900 subjects will receive a two vaccination regimen with an LT patch |
| 2 | PLACEBO_COMPARATOR | 900 subjects will receive a two vaccination regimen with a placebo patch |
| Active | EXPERIMENTAL | 358 subjects receive a two vaccination regimen with an LT patch |
| Placebo | PLACEBO_COMPARATOR | 358 subjects receive a two vaccination regimen with placebo patch |
| Name | Type | Description |
|---|---|---|
| TD Vaccine System | BIOLOGICAL | heat labile enterotoxin of E. coli (LT) |
Inclusion Criteria: * 18-64 years of age at date of first vaccination * Good health as determined by medical history and physical inspection * Females of child-bearing potential must have a negative pregnancy test prior to first vaccination in teh Country of Origin; females of child-bearing potenti...
TD Vaccine System is an investigational vaccine being developed for the prevention of traveler's diarrhea, also referred to as travelers' diarrhea. It is intended for use in adults aged 18 years and older who are traveling to regions where the condition is prevalent.
TD Vaccine System is being developed by Valneva SE, a biopharmaceutical company traded on the stock exchange under the ticker symbol VALN. The company is conducting clinical trials to evaluate the vaccine's safety and efficacy in preventing traveler's diarrhea.
TD Vaccine System is in Phase 2 clinical development. It has completed a Phase 2 efficacy study and a Phase 3 pivotal efficacy study, both of which are finished. The vaccine remains investigational and has not been approved by regulatory authorities.
TD Vaccine System has been studied in two completed clinical trials. The first, NCT00993681, was a Phase 3 pivotal efficacy study with 2,036 participants conducted in Germany, Guatemala, Mexico, and the United Kingdom. The second, NCT01040325, was a Phase 2 efficacy study with 723 participants in Germany, India, and the United Kingdom.
TD Vaccine System is a monoclonal antibody-based vaccine designed to prevent traveler's diarrhea. It works by stimulating the immune system to produce a protective response against the bacteria that commonly cause this condition, thereby reducing the risk of developing diarrhea during travel.