Clinical trial
Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid…
NCT00214461 · Sanofi, Industry · Completed
Key facts
| NCT number | NCT00214461 |
|---|---|
| Title | Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers |
| Official title | A Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study of the Safety, Tolerability and Immunogenicity of a Clostridium Difficile Toxoid Vaccine, Alum Adsorbed, in Healthy Elderly Volunteers (> or =65 Years) |
| Lead sponsor | Sanofi, Industry |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Clostridium Infections |
| Intervention type | Biological |
| Interventions | Vaccine diluent buffer (Placebo), C. difficile toxoid vaccine (2 µg), C. difficile toxoid vaccine (10 µg), C. difficile toxoid vaccine (50 µg) |
| Enrollment | 48 |
| Start date | Nov 1, 2005 |
| Primary completion | Feb 1, 2006 |
| Completion | Feb 1, 2006 |
| First posted | Sep 22, 2005 |
| Last update posted | Apr 11, 2012 |
| Countries | United States |
At a glance
- 1–9 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: