Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    H-030-009
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00214461
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : April 9, 2012
Last Update Posted : April 11, 2012
Sponsor:
Information provided by (Responsible Party):
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Clostridium Infections
Interventions Biological: Vaccine diluent buffer (Placebo)
Biological: C. difficile toxoid vaccine (2 µg)
Biological: C. difficile toxoid vaccine (10 µg)
Biological: C. difficile toxoid vaccine (50 µg)
Enrollment 48
Recruitment Details Participants were enrolled and treated from 01 November 2005 to 11 October 2006 in 3 medical centers in the US.
Pre-assignment Details A total of 48 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Arm/Group Title Placebo Vaccine Group Low-dose C. Difficile Vaccine Group Medium-dose C. Difficile Vaccine Group High-dose C. Difficile Vaccine Group
Hide Arm/Group Description Participants who received a dose of placebo, on Days 0, 28, and 56, respectively. Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively. Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively. Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
Period Title: Overall Study
Started 12 12 12 12
Completed 12 12 10 11
Not Completed 0 0 2 1
Reason Not Completed
Adverse Event             0             0             1             1
Withdrawal by Subject             0             0             1             0
Arm/Group Title Placebo Vaccine Group Low-dose C. Difficile Vaccine Group Medium-dose C. Difficile Vaccine Group High-dose C. Difficile Vaccine Group Total
Hide Arm/Group Description Participants who received a dose of placebo, on Days 0, 28, and 56, respectively. Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively. Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively. Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively. Total of all reporting groups
Overall Number of Baseline Participants 12 12 12 12 48
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 12 participants 48 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
12
 100.0%
12
 100.0%
12
 100.0%
12
 100.0%
48
 100.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
69.0  (3.59) 72.2  (5.32) 75.5  (6.47) 68.9  (4.32) 71.4  (5.60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
Female
6
  50.0%
8
  66.7%
5
  41.7%
7
  58.3%
26
  54.2%
Male
6
  50.0%
4
  33.3%
7
  58.3%
5
  41.7%
22
  45.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 12 participants 12 participants 48 participants
12 12 12 12 48
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Day 0 to 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 Low-dose C. Difficile Vaccine Group Medium-dose C. Difficile Vaccine Group High-dose C. Difficile Vaccine Group
Hide Arm/Group Description:
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
Overall Number of Participants Analyzed 12 12 12 12
Measure Type: Number
Unit of Measure: Participants
Injection site pain 3 8 4 8
Eosinophil count increased 4 5 3 5
White blood cells urine positive 3 1 5 6
Fatigue 2 3 2 4
Myalgia 2 4 1 4
Arthralgia 2 5 1 1
Injection site erythema 1 3 1 3
Headache 2 3 2 1
Back pain 1 3 0 2
Blood urea increased 1 0 3 2
Diarrhoea 1 2 2 1
White blood cell count increased 2 0 2 2
Protein urine present 0 0 3 2
Vomiting 1 2 1 1
Anorexia 2 1 0 2
Red blood cells urine positive 2 0 1 2
Nasopharyngitis 0 1 2 1
Blood bilirubin increased 0 0 2 1
Blood potassium increased 0 0 1 2
Haemoglobin decreased 0 1 2 0
Injection site warmth 0 2 0 1
Red blood cell count decreased 2 0 1 0
2.Secondary Outcome
Title 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.
Hide Description Seroconversion was defined as a ≥ 4-fold increase from baseline in a subject’s specific IgG levels: Serum Levels of Anti-toxin Immunoglobulin (IgG) against toxin A and toxin B in enzyme units (EU) were assessed by enzyme linked immunosorbent assay (ELISA).
Time Frame Day up to Day 236 post first vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Serum anti-toxin levels were assessed in the fully evaluable (Per-Protocol) population.
Arm/Group Title Placebo Vaccine Group Low-dose C. Difficile Vaccine Group Medium-dose C. Difficile Vaccine Group High-dose C. Difficile Vaccine Group
Hide Arm/Group Description:
Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
Overall Number of Participants Analyzed 11 12 9 11
Measure Type: Number
Unit of Measure: Participants
Toxin A: Day 14 0 0 1 3
Toxin A: Day 28 0 2 2 4
Toxin A: Day 56 0 6 8 11
Toxin A: Day 70 0 11 9 11
Toxin A: Day 236 0 3 4 5
Toxin B: Day 14 0 2 2 4
Toxin B: Day 28 0 3 2 5
Toxin B: Day 56 0 4 4 5
Toxin B: Day 70 0 7 5 8
Toxin B: Day 236 0 3 1 3
Time Frame Adverse event data were collected from the day of vaccination (Day 0) for up to 1 year post-vaccination
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Vaccine Group Low-dose C. Difficile Vaccine Group Medium-dose C. Difficile Vaccine Group High-dose C. Difficile Vaccine Group
Hide Arm/Group Description Participants who received a dose of placebo, on Days 0, 28, and 56, respectively. Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively. Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively. Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
All-Cause Mortality
Placebo Vaccine Group Low-dose C. Difficile Vaccine Group Medium-dose C. Difficile Vaccine Group High-dose C. Difficile Vaccine Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Vaccine Group Low-dose C. Difficile Vaccine Group Medium-dose C. Difficile Vaccine Group High-dose C. Difficile Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)      2/12 (16.67%)      0/12 (0.00%)    
Cardiac disorders         
Cardiomyopathy * 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Gastrointestinal disorders         
Diverticulitis intestinal haemorrhagic * 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
Infections and infestations         
Pneumonia * 1  0/12 (0.00%)  0 0/12 (0.00%)  0 1/12 (8.33%)  1 0/12 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
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 Low-dose C. Difficile Vaccine Group Medium-dose C. Difficile Vaccine Group High-dose C. Difficile Vaccine Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/12 (83.33%)      12/12 (100.00%)      11/12 (91.67%)      12/12 (100.00%)    
Cardiac disorders         
Cardiomyopathy * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Coronary artery disease * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Eye disorders         
Conjunctivitis * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Vitreous detachment * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Gastrointestinal disorders         
Abdominal pain * 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Constipation * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Diarrhoea * 1  1/12 (8.33%)  2/12 (16.67%)  2/12 (16.67%)  1/12 (8.33%) 
Diverticulitis intestinal haemorrhagic * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Gastrooesophageal reflux disease * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Hyperchlorhydria * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Nausea * 1  1/12 (8.33%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Vomiting * 1  1/12 (8.33%)  2/12 (16.67%)  1/12 (8.33%)  1/12 (8.33%) 
General disorders         
Asthenia * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Fatigue * 1  2/12 (16.67%)  3/12 (25.00%)  2/12 (16.67%)  4/12 (33.33%) 
Induration * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Injection site bruising * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Injection site erythema * 1  1/12 (8.33%)  3/12 (25.00%)  1/12 (8.33%)  3/12 (25.00%) 
Injection site haemorrhage * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Injection site induration * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Injection site nodule * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Injection site oedema * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Injection site pain * 1  3/12 (25.00%)  8/12 (66.67%)  4/12 (33.33%)  8/12 (66.67%) 
Injection site pruritus * 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  1/12 (8.33%) 
Injection site reaction * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%) 
Injection site swelling * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Injection site warmth * 1  0/12 (0.00%)  2/12 (16.67%)  0/12 (0.00%)  1/12 (8.33%) 
Malaise * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Pain * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Pyrexia * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Infections and infestations         
Nasopharyngitis * 1  0/12 (0.00%)  1/12 (8.33%)  2/12 (16.67%)  1/12 (8.33%) 
Pneumonia * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Upper respiratory tract infection * 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Urinary tract infection * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Injury, poisoning and procedural complications         
Muscle strain * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Thermal burn * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Investigations         
Alanine aminotransferase increased * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Blood bilirubin increased * 1  0/12 (0.00%)  0/12 (0.00%)  2/12 (16.67%)  1/12 (8.33%) 
Blood creatinine increased * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Blood potassium decreased * 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Blood potassium increased * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  2/12 (16.67%) 
Blood pressure increased * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Blood urea decreased * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Blood urea increased * 1  1/12 (8.33%)  0/12 (0.00%)  3/12 (25.00%)  2/12 (16.67%) 
Electrocardiogram ST T Change * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Eosinophil count increased * 1  4/12 (33.33%)  5/12 (41.67%)  3/12 (25.00%)  5/12 (41.67%) 
Glucose urine * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%) 
Haematocrit decreased * 1  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Haemoglobin decreased * 1  0/12 (0.00%)  1/12 (8.33%)  2/12 (16.67%)  0/12 (0.00%) 
Platelet count decreased * 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Platelet count increased * 1  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Prostate examination abnormal * 1  0/6 (0.00%)  0/4 (0.00%)  0/7 (0.00%)  1/5 (20.00%) 
Protein urine present * 1  0/12 (0.00%)  0/12 (0.00%)  3/12 (25.00%)  2/12 (16.67%) 
Red blood cell count decreased * 1  2/12 (16.67%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Red blood cell count increased * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Red blood cells urine positive * 1  2/12 (16.67%)  0/12 (0.00%)  1/12 (8.33%)  2/12 (16.67%) 
White blood cell count decreased * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
White blood cell count increased * 1  2/12 (16.67%)  0/12 (0.00%)  2/12 (16.67%)  2/12 (16.67%) 
White blood cells urine positive * 1  3/12 (25.00%)  1/12 (8.33%)  5/12 (41.67%)  6/12 (50.00%) 
Metabolism and nutrition disorders         
Anorexia * 1  2/12 (16.67%)  1/12 (8.33%)  0/12 (0.00%)  2/12 (16.67%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  2/12 (16.67%)  5/12 (41.67%)  1/12 (8.33%)  1/12 (8.33%) 
Back pain * 1  1/12 (8.33%)  3/12 (25.00%)  0/12 (0.00%)  2/12 (16.67%) 
Muscle spasms * 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Myalgia * 1  2/12 (16.67%)  4/12 (33.33%)  1/12 (8.33%)  4/12 (33.33%) 
Neck pain * 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Pain in extremity * 1  1/12 (8.33%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Nervous system disorders         
Dizziness * 1  1/12 (8.33%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
Headache * 1  2/12 (16.67%)  3/12 (25.00%)  2/12 (16.67%)  1/12 (8.33%) 
Sinus headache * 1  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%) 
Psychiatric disorders         
Insomnia * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Reproductive system and breast disorders         
Prostatitis * 1  0/6 (0.00%)  0/4 (0.00%)  1/7 (14.29%)  0/5 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%)  1/12 (8.33%) 
Dry throat * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Pharyngolarygeal pain * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Postnasal drip * 1  0/12 (0.00%)  1/12 (8.33%)  0/12 (0.00%)  0/12 (0.00%) 
Rhinorrhoea * 1  0/12 (0.00%)  0/12 (0.00%)  0/12 (0.00%)  1/12 (8.33%) 
Sinus congestion * 1  0/12 (0.00%)  1/12 (8.33%)  1/12 (8.33%)  0/12 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 8.0
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: NCT00214461     History of Changes
Other Study ID Numbers: H-030-009
First Submitted: September 16, 2005
First Posted: September 22, 2005
Results First Submitted: March 13, 2012
Results First Posted: April 9, 2012
Last Update Posted: April 11, 2012