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

Phase 1TerminatedNCT00772954

Sanofi36 enrolled

Overview

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.

This was a Phase I, randomized, placebo-controlled, double-blinded, dose ranging study designed to assess the safety, tolerability, and immunogenicity of C. difficile vaccine. The study was conducted in healthy male and female adults, 18 to 55 years old. Subjects was randomly assigned on Day 0 to receive one of two doses of C. difficile vaccine (50 or 100 mcg) or placebo (vehicle control containing alum).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Clostridium Difficile Infection Clostridium Difficile Diarrhea

Interventions

Vaccine diluent bufferBIOLOGICAL

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

Clostridium difficile toxoid vaccine (50 μg)BIOLOGICAL

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

Clostridium difficile toxoid vaccine (100 μg)BIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Adult males or females, 18 - 55 years in good general health Exclusion Criteria: * Evidence of current C. difficile infection, as determined by a positive stool C. difficile cytotoxin assay at screening * Evidence of any previous antibiotic-associated diarrhea caused by any etiology including C. difficile that required medical intervention or medication * Active or inactive irritable bowel disease, chronic abdominal pain, chronic diarrhea of any etiology, or inflammatory bowel disease.

Outcomes

Primary Outcomes

Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.

Time frame: Day 0 up to 70 days post first vaccination

Data from ClinicalTrials.gov

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