CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
Placebo (vaccine diluent) +3 morebiological
Likely dose
Clostridium difficile toxoid vaccine, 0.5 mL intramuscular on Days 0, 28, and 56AI-extracted
Key inclusion· 5
  • ✓Age 18-55 years (inclusive)
  • ✓In good general health
  • ✓Clinical lab tests within normal range
  • ✓Non-pregnant female subjects
Key exclusion· 12
  • ✕Evidence of C. difficile infection
  • ✕Previous antibiotic-associated diarrhea
  • ✕Active or inactive inflammatory bowel disease, irritable colon 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.

Search/NCT00127803
NCT00127803Phase 1Completed
CompareCT.gov

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 Adult Volunteers (18-55 Years)

Sanofi·interventional·Posted Aug 9, 2005·Updated Sep 14, 2012

In Brief

A Phase 1 clinical trial evaluating Placebo (vaccine diluent) and Clostridium difficile vaccine for Clostridium Infections. Completed, enrolled 50 participants.

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 adults aged 18-55 years of age.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Infections
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 9, 2005
Enrollment StartJul 1, 2005
Primary CompletionJan 1, 2006
Study CompletionMar 1, 2006
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 20.9 years ago

Interventions

Placebo (vaccine diluent)biological

0.5 mL, intramuscular (IM) on Days 0, 28, and 56, respectively.

Clostridium difficile vaccinebiological

0.5 mL, intramuscular on Days 0, 28, and 56, respectively.

Clostridium difficile vaccinebiological

0.5 mL, intramuscular on Days 0, 28, and 56, respectively.

Clostridium difficile vaccinebiological

0.5 mL, intramuscular on Days 0, 28, and 56, respectively.