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Study Title and Description

Safety and immunogenicity of increasing doses of a Clostridium difficile toxoid vaccine administered to healthy adults.



Key Questions Addressed
8 Key Question 8 - Case studies/series and potential harms of nonstandard interventions for CDI
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Primary Publication Information
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TitleData
Title Safety and immunogenicity of increasing doses of a Clostridium difficile toxoid vaccine administered to healthy adults.
Author Kotloff KL., Wasserman SS., Losonsky GA., Thomas W., Nichols R., Edelman R., Bridwell M., Monath TP.
Country Division of Infectious Disease and Tropical Pediatrics, Department of Pediatrics, Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, Maryland 21201, USA. kkotoff@medicine.umaryland.edu
Year 2001
Numbers Pubmed ID: 11159994
1443 (internal)

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Key Question 4 - Case studies/series and potential harms of nonstandard interventions for CDI (Table C11)
Design Details
Question... Follow Up Answer Follow-up Answer
Study Focus Randomized, double- blind, Phase 1 study of C. difficile vaccine
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Subject/Study Details 30 healthy adults (no ages reported)
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Interventions Vaccine, 6.25, 25 or 100 mg given intramuscular Five subjects at each dose level received soluble toxoid vaccine, and five subjects received an equivalent dose of toxoid adsorbed to alum.
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Clinical Diarrhea Outcomes
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C. difficile Toxin, C. difficile Culture, or Other
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Adverse Effects (AE) Harms No serious adverse events during the study: rash = 8 (subjects); abdominal pain = 6; athralgia = 2; diarrhea = 2 All subjects had local pain at injection site, especially those who received toxoid adsorbed to alum, pruritus (without urticaria) at the site of injection n = 6
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Results & Comparisons

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