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

NCT00772954 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2012-05-21

Study results available
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Summary

This Phase I, randomized, placebo-controlled, double-blinded, dose ranging study to assess the safety, tolerability, and immunogenicity of 2 dose levels of C. difficile vaccine. Population: healthy male and female adults, 18 to 55 years old.

Conditions

  • Clostridium Difficile Infection
  • Clostridium Difficile Diarrhea

Interventions

BIOLOGICAL

Vaccine diluent buffer

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

BIOLOGICAL

Clostridium difficile toxoid vaccine (50 μg)

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

BIOLOGICAL

Clostridium difficile toxoid vaccine (100 μg)

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

Sponsors & Collaborators

Principal Investigators

  • Dennis N Morrison, D.O. · Bio-Kinetic Clinical Applications, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2006-06-30
Completion
2006-06-30

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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 NCT00772954 on ClinicalTrials.gov