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 Elderly Volunteers (> or =65 Years)
Sponsor study identifier
interventional
48
1 country
2
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2006
Actual (reported)Study Completion
February 2006
Actual (reported)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 elderly subjects aged \> or = 65 years. This is the companion study to H-030-008, in which healthy younger adults have already been dosed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2006
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 16, 2005
Actual (reported)September 22, 2005
Actual (reported)November 2005
Date type not reportedThis date has not been verified as actual or estimated.
February 2006
Actual (reported)February 2006
Actual (reported)April 9, 2012
Actual (reported)Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.
Day 0 to up to 70 days post first vaccination
Number of Participants Achieving Seroconversion of Serum Immunoglobulin G (IgG) After Vaccination With Either a Formulation of C. Difficile Toxoid Vaccine or a Placebo Vaccine.
Day up to Day 236 post first vaccination
Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively.
Participants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
Participants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Greenberg RN, Marbury TC, Foglia G, Warny M. Phase I dose finding studies of an adjuvanted Clostridium difficile toxoid vaccine. Vaccine. 2012 Mar 16;30(13):2245-9. doi: 10.1016/j.vaccine.2012.01.065. Epub 2012 Feb 2.
Thomas P Marbury, MD
Orlando Clinical Research Center
Richard Greenberg, MD
University of Kentucky
48 participants (actual enrollment reported by the registry).
First Submitted
September 16, 2005
First Posted
September 22, 2005
Study Start
November 2005
Date type not reportedThis date has not been verified as actual or estimated.
Participants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2006
Actual (reported)Study Completion
February 2006
Actual (reported)Last Updated
April 11, 2012
Results First Posted
April 9, 2012
Record last verified: 2012-04
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Source: ClinicalTrials.gov.
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