Study of a Clostridium Difficile Toxoid Vaccine (ACAM-CDIFF™) in Subjects With Clostridium Difficile Infection
NCT ID: NCT00772343
Last Updated: 2013-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
116 participants
INTERVENTIONAL
2009-02-28
2012-06-30
Brief Summary
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Secondary objective: To evaluate the safety of all dose groups of ACAM-CDIFF™ vaccine versus placebo in subjects with first episode of CDI receiving antibiotics standard of care.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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Placebo Vaccine
0.9% Normal saline
0.9% Normal Saline
0.5 mL, intramuscular on Days 0, 7, and 28
Low dose
Low dose vaccine with adjuvant
Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28
High dose 1
High-dose vaccine with adjuvant
Clostridium difficile toxoid vaccine with adjuvant
0.5 mL, intramuscular on Days 0, 7, and 28
High dose 2
High-dose vaccine without adjuvant
Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28
Interventions
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0.9% Normal Saline
0.5 mL, intramuscular on Days 0, 7, and 28
Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28
Clostridium difficile toxoid vaccine with adjuvant
0.5 mL, intramuscular on Days 0, 7, and 28
Clostridium difficile toxoid vaccine
0.5 mL, intramuscular on Days 0, 7, and 28
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects who are experiencing a first event of CDI diagnosed within the last 10 days.
3. Subjects who are medically stable.
4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
Exclusion Criteria
2. Subjects who are currently or have recently been treated with immunoglobulin therapy.
3. Pregnant or breast feeding females.
4. Concurrent, acutely life-threatening diseases.
18 Years
85 Years
ALL
No
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur Inc.
Locations
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Tampa, Florida, United States
Marietta, Georgia, United States
Worcester, Massachusetts, United States
Butte, Montana, United States
Rapid City, South Dakota, United States
Birmingham Heartlands Hospital
Birmingham, , United Kingdom
Blackpool Victoria Hospital
Blackpool, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Royal Sussex County Hospital
Brighton, , United Kingdom
Southmead Hospital
Bristol, , United Kingdom
Frenchay Hospital
Bristol, , United Kingdom
St Helier Hospital
Carshalton, , United Kingdom
Cheltenham Royal Hosptial
Cheltenham, , United Kingdom
St. Richard's Hospital
Chichester, , United Kingdom
New University Hospital (Walsgrave site)
Coventry, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
West Park Hospital
Epsom, , United Kingdom
Gloucestersh Royal Hospital
Gloucester, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
Leicester Royal Infirmary
Leicester, , United Kingdom
Whittington Hospital
London, , United Kingdom
North Manchester General Hospital
Manchester, , United Kingdom
Royal Oldham Hospital
Manchester, , United Kingdom
St Mary's Hospital
Portsmouth, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Stepping Hill Hospital
Stockport, , United Kingdom
Sunderland Royal Hospital
Sunderland, , United Kingdom
St. George's Hospital
Tooting, London, , United Kingdom
Worthing General Hospital
Worthing, , United Kingdom
Countries
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Related Links
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Related Info
Other Identifiers
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2008-004907-69
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
28439/0001/001
Identifier Type: OTHER
Identifier Source: secondary_id
H-030-011
Identifier Type: -
Identifier Source: org_study_id