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Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers

NCT00127803 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-09-14

Study results available
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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.

Conditions

  • Clostridium Infections

Interventions

BIOLOGICAL

Placebo (vaccine diluent)

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

BIOLOGICAL

Clostridium difficile vaccine

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

BIOLOGICAL

Clostridium difficile vaccine

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

BIOLOGICAL

Clostridium difficile vaccine

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

Sponsors & Collaborators

Principal Investigators

  • Thomas Marbury, MD · Orlando Clinical Research Center

  • Richard Greenberg, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-07-31
Primary Completion
2006-01-31
Completion
2006-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00127803 on ClinicalTrials.gov