MedTrace Logo

Study of Different Formulations of a Clostridium Difficile Toxoid Vaccine Given at Three Different Schedules in Adults

NCT01230957 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 650

Last updated 2018-07-18

No results posted yet for this study

Summary

This study will further evaluate the ACAM-CDIFF™ vaccine in a population of middle-aged to elderly individuals at risk of exposure to Clostridium difficile because of impending hospitalization or residence in a care facility.

Primary Objectives:

* To describe the safety profile of subjects in each of the study groups.
* To describe the immune responses elicited by toxoid A and toxoid B of subjects in each of the study groups.

Observational Objective:

* To describe the occurrence of first-time Clostridium difficile infection (CDI) episodes.

Conditions

  • Clostridium Difficile Infection
  • Diarrhea

Interventions

BIOLOGICAL

Clostridium difficile toxoids A and B (Low-dose with adjuvant)

0.5 mL, Intramuscular on Days 0, 7, and 30

BIOLOGICAL

Clostridium difficile toxoids A and B (Low-dose without adjuvant)

0.5 mL, Intramuscular on Days 0, 7, and 30

BIOLOGICAL

Clostridium difficile toxoids A and B (high-dose with adjuvant)

0.5 mL, Intramuscular on Days 0, 7, and 30

BIOLOGICAL

Clostridium difficile toxoids A and B (high-dose without adjuvant)

0.5 mL, Intramuscular on Days 0, 7, and 30

BIOLOGICAL

Placebo: 0.9% normal saline

0.5 mL, Intramuscular on Days 0, 7, and 30

BIOLOGICAL

Clostridium difficile toxoids A and B (high-dose with adjuvant)

0.5 mL, Intramuscular on Days 0, 7, and 180

BIOLOGICAL

Clostridium difficile toxoids A and B (high-dose with adjuvant)

0.5 mL, Intramuscular on Days 0, 30, and 180

Sponsors & Collaborators

  • Sanofi Pasteur, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · Sanofi Pasteur Inc.

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-11-30
Completion
2013-03-31

Countries

  • United States

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 NCT01230957 on ClinicalTrials.gov