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An Open-label Study Assessing Safety, Immunogenicity and Dose Response of IC84

NCT01296386 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2014-09-25

No results posted yet for this study

Summary

An open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, A new vaccine against Clostridium Difficile (C. difficile), In healthy subjects

Conditions

  • Clostridium Difficile Infection

Interventions

BIOLOGICAL

IC84

IC84, a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B, which will be administered at two different doses: 75 and 200 µg without or with Al(OH)3, respectively, intramuscular (i.m.) injection, four vaccinations on Day 0, 7, 28 and 56.

Sponsors & Collaborators

  • Valneva Austria GmbH

    lead INDUSTRY

Principal Investigators

  • Andrea Ayad, Dr. · Valneva Austria GmbH

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Austria
  • Hungary

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 NCT01296386 on ClinicalTrials.gov