Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Viaskin PT · 1 trial · 1 indication
* Solicited AEs occurring from the time of each application through 14 days following Viaskin PT application; * Unsolicited AEs from the time of application through 28 days following the 1st application; * Serious Adverse Events from the time of the inform consent form signature through the final study visit of subject.
| Arm | Type | Description |
|---|---|---|
| Viaskin PT 25 mcg | EXPERIMENTAL | Viaskin PT 25 mcg |
| Viaskin PT 50 mcg | EXPERIMENTAL | Viaskin PT 50 mcg |
| Viaskin PT Placebo | PLACEBO_COMPARATOR | Viaskin PT Placebo |
| Name | Type | Description |
|---|---|---|
| Viaskin PT 25 mcg | BIOLOGICAL | Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14). |
| Viaskin PT 50 mcg | BIOLOGICAL | Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14). |
| Viaskin PT Placebo | BIOLOGICAL | Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14). |
| Boostrix™ | BIOLOGICAL | Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal recall of their immunity against pertussis. |
Inclusion Criteria: * Has provided written informed consent before enrollment; * Adult male or female, ages 18 to 40 years (inclusive) at the time of enrollment; * Non-pregnant, non-lactating female; * Free of clinically significant health problems, as determined by pertinent medical history and cl...
Viaskin PT is an investigational vaccine being developed for the prevention of whooping cough, also known as pertussis. It is currently in Phase 1 clinical development and is not yet approved for use.
Viaskin PT is being developed by DBV Technologies S.A., a biopharmaceutical company listed on the stock exchange under the ticker symbol DBVT.
Viaskin PT is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. A Phase 1 trial has been completed to evaluate its safety and immunogenicity.
Viaskin PT has been studied in one completed Phase 1 clinical trial, identified as NCT03035370. This trial, titled 'Viaskin Pertussis Vaccine Trial,' enrolled 102 healthy adult volunteers in Switzerland and was randomized, double-blind, and placebo-controlled.
Viaskin PT is a monoclonal antibody-based vaccine designed to elicit an immune response against whooping cough. It is administered via a skin patch, which delivers the antigen to the immune system to stimulate protective immunity.