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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02316470 | Dose-Confirmation, Immunogenicity and Safety Study of the Clostridium Difficile Vaccine Candidate VLA84 in Healthy Adults Aged 50 Years and Older. Phase II Study | PHASE2 | COMPLETED | 500 | — | — | Dec 1, 2014 | Oct 1, 2015 | Jun 8, 2017 | 10 | United States, Germany |
Seroconversion Rate (SCR), defined as percentage of subjects achieving a ≥4-fold increase in antibody titer from Day 0, for IgG against both Toxin A and Toxin B on Day 56;
| Arm | Type | Description |
|---|---|---|
| VLA84 75 mcg (microgram) w/o Alum | ACTIVE_COMPARATOR | VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections |
| VLA84 200 mcg w/o Alum | ACTIVE_COMPARATOR | VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections |
| VLA84 200 mcg with Alum | ACTIVE_COMPARATOR | VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections |
| Placebo | PLACEBO_COMPARATOR | Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections |
| Name | Type | Description |
|---|---|---|
| VLA84 | BIOLOGICAL | a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B |
| Placebo | BIOLOGICAL | phosphate buffered saline (PBS) solution |
Inclusion Criteria: * Subjects aged ≥50 years of good general health, including subjects with pharmacologically controlled conditions like hypercholesterolemia, hypertension, or type 2 diabetes mellitus. * Informed consent form has been signed and dated Exclusion Criteria: * Subjects with any con...