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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01896830 | Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan | PHASE1 | COMPLETED | 102 | — | — | Jul 1, 2013 | Jun 1, 2014 | Jul 18, 2018 | 1 | Japan |
Solicited injection site reactions: Pain, Redness, and Swelling. Solicited systemic reactions: Fever (temperature), Headache, Malaise, Myalgia, and Arthralgia.
Serum antibody concentrations to toxins A and B will be measured by enzyme-linked immunosorbent assay (ELISA)
Serum antibody titers against toxins A and B will be measured by toxin neutralizing assay (TNA)
| Arm | Type | Description |
|---|---|---|
| Vaccine Group | EXPERIMENTAL | Participants will receive the candidate C. difficile toxoid vaccine |
| Placebo Group | PLACEBO_COMPARATOR | Participants will receive a placebo vaccine |
| Name | Type | Description |
|---|---|---|
| Clostridium difficile Toxoid Vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
| 0.9% normal saline | BIOLOGICAL | 0.5 mL, intramuscular |
Inclusion Criteria: * Healthy adult subjects aged 40 to 75 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: * Subject is pregnant, or lactating, or of childbearing pot...