# Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

> **NCT00772954** · PHASE1 · TERMINATED · sponsor: **Sanofi** · enrollment: 36 (actual)

## Conditions studied

- Clostridium Difficile Infection
- Clostridium Difficile Diarrhea

## Interventions

- **BIOLOGICAL:** Vaccine diluent buffer
- **BIOLOGICAL:** Clostridium difficile toxoid vaccine (50 μg)
- **BIOLOGICAL:** Clostridium difficile toxoid vaccine (100 μg)

## Key facts

- **NCT ID:** NCT00772954
- **Lead sponsor:** Sanofi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** TERMINATED
- **Start date:** 2006-03
- **Primary completion:** 2006-06
- **Final completion:** 2006-06
- **Target enrollment:** 36 (ACTUAL)
- **Why stopped:** Issues with CTM stability.
- **Last updated:** 2012-05-21


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00772954

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00772954, "Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity". Retrieved via AI Analytics 2026-06-15 from https://api.ai-analytics.org/clinical/NCT00772954. Licensed CC0.

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