Clostridium Difficile Associated Disease Clinical Trial
Official title:
A Phase 1, Placebo-Controlled, Randomized, Observer-Blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Clostridium Difficile Vaccine Administered With Or Without Adjuvant, In A 3-Dose Regimen In Healthy Adults Aged 50 To 85 Years
This is a first-in-human study (phase 1) of a 3-dose vaccination regimen with one of three dose levels of C difficile vaccine with or without adjuvant in healthy adults aged 50 to 85 years. The main goal of the study is to determine how safe and well-tolerated the vaccine is. In addition, the study aims to assess the immune response to the C difficile vaccine.
n/a
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Basic Science
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03579459 -
Evaluation Of Clostridium Difficile Vaccine Lot Consistency In Healthy Adults 65 To 85 Years Of Age
|
Phase 3 | |
| Active, not recruiting |
NCT02117570 -
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
|
Phase 2 | |
| Completed |
NCT02561195 -
A Study To Investigate Two 3-dose Schedules Of A Clostridium Difficile Vaccine In Healthy Adults Aged 65 to 85 Years
|
Phase 2 | |
| Completed |
NCT02725437 -
Clostridium Difficile Vaccine Safety, Tolerability, and Immunogenicity Study in Japanese Adults
|
Phase 1 | |
| Completed |
NCT03918629 -
Clostridium Difficile Vaccine 2-Dose Versus 3-Dose Study
|
Phase 3 |