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Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection

NCT00772343 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2013-09-17

No results posted yet for this study

Summary

Primary objective: To compare the event rate of CDI in groups assigned to ACAM-CDIFF™ vaccine versus placebo in the 9 week period after the third dose of the study vaccine in subjects with first episode of CDI receiving antibiotics standard of care.

Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus placebo in subjects with first episode of CDI receiving antibiotics standard of care.

Conditions

  • Diarrhea
  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

0.9% Normal Saline

0.5 mL, intramuscular on Days 0, 7, and 28

BIOLOGICAL

Clostridium difficile toxoid vaccine

0.5 mL, intramuscular on Days 0, 7, and 28

BIOLOGICAL

Clostridium difficile toxoid vaccine with adjuvant

0.5 mL, intramuscular on Days 0, 7, and 28

BIOLOGICAL

Clostridium difficile toxoid vaccine

0.5 mL, intramuscular on Days 0, 7, and 28

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-07-31
Completion
2012-06-30

Countries

  • United States
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT00772343 on ClinicalTrials.gov