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Study of a Candidate Clostridium Difficile Toxoid Vaccine in Subjects at Risk for C. Difficile Infection

NCT01887912 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 9302

Last updated 2022-03-28

Study results available
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Summary

The aim of this study was to evaluate the efficacy of the Clostridium difficile vaccine to prevent primary symptomatic C. difficile infection (CDI) in participants at risk for CDI where there is a substantial unmet medical need.

Primary objective:

* To assess the efficacy of the C. difficile vaccine in preventing the onset of symptomatic primary CDI confirmed by polymerase chain reaction (PCR) in adult participants aged \>= 50 years who are at risk for CDI and have received at least 1 injection.

Secondary Objectives:

Efficacy:

* To assess prevention of symptomatic PCR-confirmed primary CDI cases after 3 injections administered at 0, 7, and 30 days.
* To assess prevention of symptomatic PCR-confirmed primary CDI cases after completion of at least 2 injections.

Immunogenicity:

* To describe the immunogenicity to toxin A and toxin B at specific time points in a subset of participant and in participants with CDI at Day 0 and Day 60.

Safety:

* To describe the safety profile of all participants who received at least 1 injection.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

C. difficile Toxoid Vaccine

0.5 mL, Intramuscular

BIOLOGICAL

Placebo: 0.9% normal saline

0.5 mL, Intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-30
Primary Completion
2018-06-12
Completion
2018-06-12
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Colombia
  • Costa Rica
  • Denmark
  • Dominican Republic
  • Finland
  • France
  • Germany
  • Guatemala
  • Japan
  • Mexico
  • Panama
  • Peru
  • Philippines
  • Poland
  • Puerto Rico
  • Singapore
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • United Kingdom

Study Locations

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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 NCT01887912 on ClinicalTrials.gov