At a glance
ClinicalIndex Comparison Record- ✓Age ≥65 years
- ✓Good general health status
- ✓Clinical laboratory tests within normal range
- ✓Females must be post-menopausal
- ✕Evidence of current or past C. difficile infection
- ✕History of antibiotic-associated diarrhea
- ✕Active or inactive inflammatory bowel disease, irritable bowel syndrome, chronic abdominal pain, or chronic diarrhea
- ✕History of malignancy within 5 years
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating Vaccine diluent buffer (Placebo), C. difficile toxoid vaccine (2 µg), and 2 other interventions for Clostridium Infections. Completed, enrolled 48 participants across 2 sites.
Detailed Summary
The purpose of this study is to determine the safety and tolerability of a modified C. difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy elderly subjects aged \> or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.
Study Details
Timeline
Interventions
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.