At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,317 enrolled
Drug / intervention
Clostridium difficile vaccine +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A PHASE 3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED STUDY TO EVALUATE THE LOT CONSISTENCY, SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CLOSTRIDIUM DIFFICILE VACCINE IN HEALTHY ADULTS 65 TO 85 YEARS OF AGE
In Brief
A Phase 3 clinical trial evaluating Clostridium difficile vaccine and placebo for Clostridium Difficile Associated Disease. Completed, enrolled 1,317 participants across 24 sites.
Detailed Summary
This study will investigate a Clostridium difficile vaccine in healthy adults 65 to 85 years of age, who will each receive 3 doses of vaccine. The study will assess the lot consistency, safety, and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsClostridium Difficile Associated Disease
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 2018
Enrollment StartJul 2018
Primary CompletionAug 2019
TodayJul 2026
First PostedJul 6, 2018
Enrollment StartJul 31, 2018
Primary CompletionAug 6, 2019
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 8.0 years ago
Interventions
Clostridium difficile vaccinebiological
Toxoid based Clostridium difficile vaccine
placebobiological
Normal saline solution