Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as heat-labile enterotoxin of E. coli (LT)
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 developed for the prevention of traveler's diarrhea. It is designed to protect adult travelers against diarrheal illness acquired during travel to regions where the condition is common. The vaccine is being studied in healthy adult volunteers aged 18 years and older.
TD Vaccine System is being developed by Valneva SE, a vaccine company whose shares trade under the ticker VALN. Valneva has sponsored the clinical development program for this traveler's diarrhea vaccine candidate, including the Phase 2 and Phase 3 efficacy studies conducted in multiple countries.
TD Vaccine System has reached Phase 3 clinical development. Its pivotal Phase 3 efficacy trial, NCT00993681, has been completed, and an earlier Phase 2 efficacy study, NCT01040325, was also completed. The vaccine remains investigational and is not described as approved.
TD Vaccine System has been evaluated in two completed clinical trials. NCT00993681 was a Phase 3 pivotal efficacy study enrolling 2,036 participants across Germany, Guatemala, Mexico, and the United Kingdom. NCT01040325 was a Phase 2 efficacy study enrolling 723 participants in Germany, India, and the United Kingdom.
Both TD Vaccine System trials were randomized, double-blind, and placebo-controlled studies in healthy adult volunteers aged 18 years and older, with enrollment open to all sexes. Together the two completed trials enrolled 2,759 participants and assessed the vaccine for preventing traveler's diarrhea.