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

NCT00214461 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-04-11

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 elderly subjects aged \> or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.

Conditions

  • Clostridium Infections

Interventions

BIOLOGICAL

Vaccine diluent buffer (Placebo)

0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.

BIOLOGICAL

C. difficile toxoid vaccine (2 µg)

0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.

BIOLOGICAL

C. difficile toxoid vaccine (10 µg)

0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.

BIOLOGICAL

C. difficile toxoid vaccine (50 µg)

0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.

Sponsors & Collaborators

Principal Investigators

  • Thomas P Marbury, MD · Orlando Clinical Research Center

  • Richard Greenberg, MD · University of Kentucky

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT00214461 on ClinicalTrials.gov