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Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan

NCT01896830 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2018-07-18

No results posted yet for this study

Summary

The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese population.

Primary objectives:

* To describe the safety profile of all subjects who receive at least 1 injection
* To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples obtained on Days 0, 14, 30, and 60.

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

Clostridium difficile Toxoid Vaccine

0.5 mL, intramuscular

BIOLOGICAL

0.9% normal saline

0.5 mL, intramuscular

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur K.K

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2013-10-31
Completion
2014-06-30

Countries

  • Japan

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 NCT01896830 on ClinicalTrials.gov