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Trial record 1 of 1 for:    H-030-010
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Phase I Randomized, Placebo-Controlled, Double-Blind, Dose Ranging Study, Safety, Tolerability and Immunogenicity

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ClinicalTrials.gov Identifier: NCT00772954
Recruitment Status : Terminated (Issues with CTM stability.)
First Posted : October 15, 2008
Results First Posted : May 21, 2012
Last Update Posted : May 21, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Clostridium Difficile Infection
Clostridium Difficile Diarrhea
Interventions Biological: Vaccine diluent buffer
Biological: Clostridium difficile toxoid vaccine (50 μg)
Biological: Clostridium difficile toxoid vaccine (100 μg)
Enrollment 36
Recruitment Details Participants were enrolled on 28 March 2006 in 2 clinical centers in the US.
Pre-assignment Details A total of 36 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.
Arm/Group Title Placebo Vaccine Group Clostridium Difficile Toxoid Vaccine Group 1 Clostridium Difficile Toxoid Vaccine Group 2
Hide Arm/Group Description Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28. Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
Period Title: Overall Study
Started 12 12 12
Completed 12 12 11
Not Completed 0 0 1
Reason Not Completed
Adverse Event             0             0             1
Arm/Group Title Placebo Vaccine Group Clostridium Difficile Toxoid Vaccine Group 1 Clostridium Difficile Toxoid Vaccine Group 2 Total
Hide Arm/Group Description Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28. Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 36
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 36 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
12
 100.0%
12
 100.0%
36
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 36 participants
38.3  (12.98) 36.9  (12.67) 30.0  (8.57) 35.1  (11.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 36 participants
Female
7
  58.3%
11
  91.7%
5
  41.7%
23
  63.9%
Male
5
  41.7%
1
   8.3%
7
  58.3%
13
  36.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 12 participants 36 participants
12 12 12 36
1.Primary Outcome
Title Number of Participants Reporting Treatment-Emergent Adverse Events Post-vaccination With One of Two Formulations of Clostridium Difficile Toxoid Vaccine or a Placebo Vaccine.
Hide Description [Not Specified]
Time Frame Day 0 up to 70 days post first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Safety assessments were on the safety population.
Arm/Group Title Placebo Vaccine Group Clostridium Difficile Toxoid Vaccine Group 1 Clostridium Difficile Toxoid Vaccine Group 2
Hide Arm/Group Description:
Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28.
Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
Overall Number of Participants Analyzed 12 12 12
Measure Type: Number
Unit of Measure: Participants
Injection site pain 7 12 9
Headache 5 4 5
Blood potassium decreased 1 4 3
Protein urine present 1 4 3
White blood cell count increased 1 4 3
Diarrhoea 3 3 2
Fatigue 3 3 2
Myalgia 1 5 1
White blood cells urine positive 2 2 3
Eosinophil count increased 3 1 3
Abdominal pain 2 1 3
Injection site erythema 2 3 1
Red blood cells urine positive 2 2 2
Injection site swelling 0 4 1
Injection site warmth 0 2 2
Malaise 0 3 0
Blood urea increased 2 1 0
Sinus congestion 2 0 1
Urine ketone body present 0 0 2
Time Frame Adverse events data were collected from the day of vaccination 1 (Day 0) to up to 8 months post-vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Vaccine Group Clostridium Difficile Toxoid Vaccine Group 1 Clostridium Difficile Toxoid Vaccine Group 2
Hide Arm/Group Description Participants received a dose of placebo (vaccine diluent) on Day 0 and Day 28. Participants received a dose of 50 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28. Participants received a dose of 100 μg Clostridium difficile toxoid vaccine on Day 0 and Day 28.
All-Cause Mortality
Placebo Vaccine Group Clostridium Difficile Toxoid Vaccine Group 1 Clostridium Difficile Toxoid Vaccine Group 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vaccine Group Clostridium Difficile Toxoid Vaccine Group 1 Clostridium Difficile Toxoid Vaccine Group 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Vaccine Group Clostridium Difficile Toxoid Vaccine Group 1 Clostridium Difficile Toxoid Vaccine Group 2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   11/12 (91.67%)   12/12 (100.00%)   12/12 (100.00%) 
Gastrointestinal disorders       
Diarrhoea * 1  3/12 (25.00%)  3/12 (25.00%)  2/12 (16.67%) 
Abdominal pain * 1  2/12 (16.67%)  1/12 (8.33%)  3/12 (25.00%) 
Abdominal pain lower * 2  2/12 (16.67%)  1/12 (8.33%)  3/12 (25.00%) 
Nausea * 2  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Toothache * 2  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
General disorders       
Injection site pain * 1  7/12 (58.33%)  12/12 (100.00%)  9/12 (75.00%) 
Fatigue * 1  3/12 (25.00%)  3/12 (25.00%)  2/12 (16.67%) 
Injection site erythema * 1  2/12 (16.67%)  3/12 (25.00%)  1/12 (8.33%) 
Injection site swelling * 1  0/12 (0.00%)  4/12 (33.33%)  1/12 (8.33%) 
Injection site warmth * 1  0/12 (0.00%)  2/12 (16.67%)  2/12 (16.67%) 
Malaise * 1  0/12 (0.00%)  3/12 (25.00%)  0/12 (0.00%) 
Injection site hemorrhage * 2  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Injection site induration * 2  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Injection site pruritus * 2  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Pyrexia * 2  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Infections and infestations       
Nasopharyngitis * 2  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Sinusitis * 2  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications       
Procedural pain * 2  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Investigations       
Blood potassium decreased * 1  1/12 (8.33%)  4/12 (33.33%)  3/12 (25.00%) 
Protein urine present * 1  1/12 (8.33%)  4/12 (33.33%)  3/12 (25.00%) 
White blood cell count increased * 1  1/12 (8.33%)  4/12 (33.33%)  3/12 (25.00%) 
White blood cells urine positive * 1  2/12 (16.67%)  2/12 (16.67%)  3/12 (25.00%) 
Eosinophil count increased * 1  3/12 (25.00%)  1/12 (8.33%)  3/12 (25.00%) 
Red blood cells urine positive * 1  2/12 (16.67%)  2/12 (16.67%)  2/12 (16.67%) 
Blood urea increased * 1  2/12 (16.67%)  1/12 (8.33%)  0/12 (0.00%) 
Urine ketone body present * 1  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%) 
Blood bilirubin increased * 2  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Blood calcium decreased * 2  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Haematocrit decreased * 2  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Monocyte count increased * 2  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
White blood cell count decreased * 2  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Metabolism and nutrition disorders       
Anorexia * 2  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Musculoskeletal and connective tissue disorders       
Myalgia * 1  1/12 (8.33%)  5/12 (41.67%)  1/12 (8.33%) 
Arthralgia * 2  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Back pain * 2  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Pain in extremity * 2  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Pain in jaw * 2  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Shoulder pain * 2  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Musculoskeletal stiffness * 2  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Nervous system disorders       
Headache * 1  5/12 (41.67%)  4/12 (33.33%)  5/12 (41.67%) 
Psychiatric disorders       
Restlessness * 2  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Reproductive system and breast disorders       
Cervical dysplasia * 2  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Dysmenorrhoea * 2  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Respiratory, thoracic and mediastinal disorders       
Sinus congestion * 1  2/12 (16.67%)  0/12 (0.00%)  1/12 (8.33%) 
Pharyngolaryngeal pain * 2  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Rhinitis allergic * 2  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Skin and subcutaneous tissue disorders       
Dermatitis contact * 2  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Hyperhidrosis * 2  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Rosacea * 2  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.1
2
Term from vocabulary, MedDRA 8.0
This study was terminated early in light of issues with CTM stability. All other study procedures and visits were performed per protocol.
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.
Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00772954     History of Changes
Other Study ID Numbers: H-030-010
First Submitted: October 10, 2008
First Posted: October 15, 2008
Results First Submitted: March 13, 2012
Results First Posted: May 21, 2012
Last Update Posted: May 21, 2012