Clostridium Difficile Infection Clinical Trial
Official title:
An Open-label Phase 1 Study Assessing the Safety, Immunogenicity and Dose Response of IC84, a New Vaccine Against Clostridium Difficile, in Healthy Subjects
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
This is an open-label, partially randomized, dose escalation Phase 1 study which will
consist of a part A in healthy adults aged between ≥18 and <65 years and a part B in healthy
elderly ≥65 years, the latter age group being the most vulnerable population to suffer from
C. difficile infections.
Part A consists of 3 vaccinations on Day0, Day7 and Day21 with the following groups:
Group A: IC84 20 mcg (microgram)with Alum Group B: IC84 75 mcg (microgram)with Alum Group C:
IC84 75 mcg (microgram)without Alum Group D: IC84 200 mcg(microgram)with Alum Group E: IC84
200 mcg(microgram)without Alum
Part A was already finished and part B is now ongoing. All information which could be find
under the other sections are referring to the information on Part B.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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