Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03035370 | Viaskin Pertussis Vaccine Trial | PHASE1 | COMPLETED | 102 | — | — | Sep 5, 2016 | Apr 25, 2018 | Mar 2, 2020 | 1 | Switzerland |
* 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...