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Safety, Tolerability, and Immunogenicity Study of a Clostridium Difficile Toxoid Vaccine in Healthy Adult Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00127803
First received: August 5, 2005
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
Results First Received: March 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Prevention
Condition: Clostridium Infections
Interventions: Biological: Placebo (vaccine diluent)
Biological: Clostridium difficile vaccine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled from 13 July 2005 to 27 July 2005 in 2 medical centers in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 50 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.

Reporting Groups
  Description
Placebo Group Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
Low Dose Vaccine Group Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
Medium Dose Vaccine Group Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
High Dose Vaccine Group Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.

Participant Flow:   Overall Study
    Placebo Group     Low Dose Vaccine Group     Medium Dose Vaccine Group     High Dose Vaccine Group  
STARTED     13     13     12     12  
COMPLETED     10     13     12     11  
NOT COMPLETED     3     0     0     1  
Adverse Event                 2                 0                 0                 0  
Withdrawal by Subject                 1                 0                 0                 0  
Lost to Follow-up                 0                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Placebo Group Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
Low Dose Vaccine Group Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
Medium Dose Vaccine Group Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
High Dose Vaccine Group Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
Total Total of all reporting groups

Baseline Measures
    Placebo Group     Low Dose Vaccine Group     Medium Dose Vaccine Group     High Dose Vaccine Group     Total  
Number of Participants  
[units: participants]
 		  13     13     12     12     50  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     13     13     12     12     50  
>=65 years     0     0     0     0     0  
Age  
[units: Years]
Mean ± Standard Deviation 		  33.6  ± 12.49     30.8  ± 10.26     30.4  ± 9.78     32.6  ± 9.07     31.9  ± 10.28  
Gender  
[units: participants]
 		         
Female     10     6     8     9     33  
Male     3     7     4     3     17  
Region of Enrollment  
[units: participants]
 		         
United States     13     13     12     12     50  



  Outcome Measures
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1.  Primary:   Number of Participants Reporting Solicited Injection Site Erythema and Tenderness Post-vaccination With Either One of Three Formulations of Clostridium Difficile Vaccines or a Placebo Vaccine.   [ Time Frame: Day 0 and up to 7 days post each vaccination ]
  Show Outcome Measure 1

2.  Primary:   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.   [ Time Frame: Day 0 to up to 70 days post-first vaccination ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Seroconversion for Toxin A and Toxin B Post-vaccination With Either One of Three Formulations of the Clostridium Difficile Vaccine or a Placebo Vaccine.   [ Time Frame: Days 28, 56, 70, and 236 Post First Vaccination ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com


No publications provided by Sanofi

Publications automatically indexed to this study:


Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00127803     History of Changes
Other Study ID Numbers: H-030-008
Study First Received: August 5, 2005
Results First Received: March 13, 2012
Last Updated: September 7, 2012
Health Authority: United States: Food and Drug Administration