Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00127803
Status:
COMPLETED
Last Update Posted:
2012-09-14
First Post:
2005-08-05
Brief Title:
Safety Tolerability and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
Official Title:
A Phase I Randomized Placebo-Controlled Double-Blind Dose-Ranging Study of the Safety Tolerability and Immunogenicity of a Clostridium Difficile Toxoid Vaccine Alum Adsorbed in Healthy Adult Volunteers 18-55 Years
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine the safety and tolerability of a modified C difficile vaccine at 3 dose levels compared with a placebo control administered via intramuscular injection in healthy adults aged 18-55 years of age
Detailed Description:
Clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries Hospital outbreaks of Clostridium difficile-associated diarrhea CDAD are associated with substantial patient morbidity and mortality Conventional therapy with antibiotics often results in secondary infection with resistant organisms or clinical relapse after discontinuation of the antimicrobial course New strategies are needed to limit the impact of this opportunistic pathogen Considerable evidence exists that immunity against C difficile toxins may be effective in controlling CDAD 48 subjects will be enrolled to receive one of three dose levels of modified C difficile vaccine or placebo administered on a 3-dose schedule The study consists of a 30-day screening period a 70-day treatment period one follow-up phone interview 2 months after the last vaccination and one follow-up clinic visit 6 months after the last vaccination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None