drugset / Trial / NCT00772954
Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity
RandomizedParallel-groupTriple-blindTreatment
Summary
This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.
Timeline
- Start
- 2006-03
- Primary completion
- 2006-06
- Completion
- 2006-06
Outcome
Outcome not reported
Stopped: “Issues with CTM stability.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Clostridium difficile toxoid vaccine | Vaccine | 50 ug | Intramuscular |
| Subject | Clostridium difficile toxoid vaccine | Vaccine | 100 ug | Intramuscular |