Safety, Tolerability, and Immunogenicity of a Clostridium Difficile Toxoid Vaccine in Healthy Elderly Volunteers
Sponsor
Sanofi (Industry)
Overall Status
Completed
CT.gov ID
NCT00214461
Collaborator
(none)
48
2
4
3
24
7.9
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
Clostridium difficile is the leading infectious cause of nosocomial diarrhea in developed countries. Hospital outbreaks of Clostridium difficile-associated diarrhea (CDAD) are associated with substantial patient morbidity and mortality. Conventional therapy with antibiotics often results in secondary infection with resistant organisms or clinical relapse after discontinuation of the antimicrobial course. New strategies are needed to limit the impact of this opportunistic pathogen. Considerable evidence exists that immunity against C. difficile toxins may be effective in controlling CDAD. 48 subjects will be enrolled to receive one of three dose levels of modified C difficile vaccine or placebo administered on a 3-dose schedule. The study consists of a 30-day screening period, a 70-day treatment period, one follow-up phone interview 2 months after the last vaccination, and one follow-up clinic visit 6 months after the last vaccination.
Study Design
Study Type:
Interventional
Actual Enrollment
:
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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)
Study Start Date
:
Nov 1, 2005
Actual Primary Completion Date
:
Feb 1, 2006
Actual Study Completion Date
:
Feb 1, 2006
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Vaccine Group Participants will receive a dose of vaccine diluent (placebo) on Days 0, 28 and 56, respectively. |
Biological: Vaccine diluent buffer (Placebo)
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
|
| Experimental: Low Dose Vaccine Group Participants will receive a dose of vaccine containing of 2 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. |
Biological: C. difficile toxoid vaccine (2 µg)
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
|
| Experimental: Medium dose vaccine group Participants will receive a dose of vaccine containing of 10 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. |
Biological: C. difficile toxoid vaccine (10 µg)
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
|
| Experimental: High dose vaccine group Participants will receive a dose of vaccine containing of 50 µg Clostridium Difficile toxoid on Days 0, 28 and 56, respectively. |
Biological: C. difficile toxoid vaccine (50 µg)
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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]
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).
Eligibility Criteria
Criteria
Ages Eligible for Study:
65 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Adult males or females, > or = 65 years
-
In good general health
-
Clinical lab tests within normal range
-
Females must be post-menopausal
-
Able and willing to participate for duration of study and must not participate in any other experimental study for at least 60 days after receiving the last dose of study vaccine
Exclusion Criteria:
-
Evidence of C. difficile infection
-
Evidence of any previous antibiotic-associated diarrhea
-
Active or inactive inflammatory bowel disease, irritable colon syndrome, chronic abdominal pain or other chronic diarrhea
-
History of malignancy within 5 years
-
History of anaphylaxis, asthma or severe vaccine or severe allergic drug reaction
-
Known or suspected history of immunodeficiency
-
Active or inactive immune-mediated or inflammatory disease
-
History of drug or alcohol abuse disorders;
-
Serology positive for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV)
-
Receipt of antibiotic therapy or an investigational drug within prior 30 days
-
Blood or organ donation within prior 30 days.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Orlando Clinical Research Center | Orlando | Florida | United States | 32809 |
| 2 | University of Kentucky | Lexington | Kentucky | United States | 40536 |
Sponsors and Collaborators
- Sanofi
Investigators
- Principal Investigator: Thomas P Marbury, MD, Orlando Clinical Research Center
- Principal Investigator: Richard Greenberg, MD, University of Kentucky
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00214461
Other Study ID Numbers:
- H-030-009
First Posted:
Sep 22, 2005
Last Update Posted:
Apr 11, 2012
Last Verified:
Apr 1, 2012
Keywords provided by Sanofi
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Participants were enrolled and treated from 01 November 2005 to 11 October 2006 in 3 medical centers in the US. |
|---|---|
| Pre-assignment Detail | 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 |
|---|---|---|---|---|
| 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 |
Baseline Characteristics
| 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 |
|---|---|---|---|---|---|
| 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 Participants | 12 | 12 | 12 | 12 | 48 |
| Age (Count of Participants) | |||||
| <=18 years |
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%
|
| >=65 years |
12
100%
|
12
100%
|
12
100%
|
12
100%
|
48
100%
|
| Age (Years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [Years] |
69.0
(3.59)
|
72.2
(5.32)
|
75.5
(6.47)
|
68.9
(4.32)
|
71.4
(5.60)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
6
50%
|
8
66.7%
|
5
41.7%
|
7
58.3%
|
26
54.2%
|
| Male |
6
50%
|
4
33.3%
|
7
58.3%
|
5
41.7%
|
22
45.8%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
12
100%
|
12
100%
|
12
100%
|
12
100%
|
48
100%
|
Outcome Measures
| 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. |
|---|---|
| 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 |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 11 | 12 | 9 | 11 |
| Toxin A: Day 14 |
0
0%
|
0
0%
|
1
8.3%
|
3
25%
|
| Toxin A: Day 28 |
0
0%
|
2
16.7%
|
2
16.7%
|
4
33.3%
|
| Toxin A: Day 56 |
0
0%
|
6
50%
|
8
66.7%
|
11
91.7%
|
| Toxin A: Day 70 |
0
0%
|
11
91.7%
|
9
75%
|
11
91.7%
|
| Toxin A: Day 236 |
0
0%
|
3
25%
|
4
33.3%
|
5
41.7%
|
| Toxin B: Day 14 |
0
0%
|
2
16.7%
|
2
16.7%
|
4
33.3%
|
| Toxin B: Day 28 |
0
0%
|
3
25%
|
2
16.7%
|
5
41.7%
|
| Toxin B: Day 56 |
0
0%
|
4
33.3%
|
4
33.3%
|
5
41.7%
|
| Toxin B: Day 70 |
0
0%
|
7
58.3%
|
5
41.7%
|
8
66.7%
|
| Toxin B: Day 236 |
0
0%
|
3
25%
|
1
8.3%
|
3
25%
|
| 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. |
|---|---|
| Description | |
| Time Frame | Day 0 to up to 70 days post first vaccination |
Outcome Measure Data
| 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 |
|---|---|---|---|---|
| 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. |
| Measure Participants | 12 | 12 | 12 | 12 |
| Injection site pain |
3
25%
|
8
66.7%
|
4
33.3%
|
8
66.7%
|
| Eosinophil count increased |
4
33.3%
|
5
41.7%
|
3
25%
|
5
41.7%
|
| White blood cells urine positive |
3
25%
|
1
8.3%
|
5
41.7%
|
6
50%
|
| Fatigue |
2
16.7%
|
3
25%
|
2
16.7%
|
4
33.3%
|
| Myalgia |
2
16.7%
|
4
33.3%
|
1
8.3%
|
4
33.3%
|
| Arthralgia |
2
16.7%
|
5
41.7%
|
1
8.3%
|
1
8.3%
|
| Injection site erythema |
1
8.3%
|
3
25%
|
1
8.3%
|
3
25%
|
| Headache |
2
16.7%
|
3
25%
|
2
16.7%
|
1
8.3%
|
| Back pain |
1
8.3%
|
3
25%
|
0
0%
|
2
16.7%
|
| Blood urea increased |
1
8.3%
|
0
0%
|
3
25%
|
2
16.7%
|
| Diarrhoea |
1
8.3%
|
2
16.7%
|
2
16.7%
|
1
8.3%
|
| White blood cell count increased |
2
16.7%
|
0
0%
|
2
16.7%
|
2
16.7%
|
| Protein urine present |
0
0%
|
0
0%
|
3
25%
|
2
16.7%
|
| Vomiting |
1
8.3%
|
2
16.7%
|
1
8.3%
|
1
8.3%
|
| Anorexia |
2
16.7%
|
1
8.3%
|
0
0%
|
2
16.7%
|
| Red blood cells urine positive |
2
16.7%
|
0
0%
|
1
8.3%
|
2
16.7%
|
| Nasopharyngitis |
0
0%
|
1
8.3%
|
2
16.7%
|
1
8.3%
|
| Blood bilirubin increased |
0
0%
|
0
0%
|
2
16.7%
|
1
8.3%
|
| Blood potassium increased |
0
0%
|
0
0%
|
1
8.3%
|
2
16.7%
|
| Haemoglobin decreased |
0
0%
|
1
8.3%
|
2
16.7%
|
0
0%
|
| Injection site warmth |
0
0%
|
2
16.7%
|
0
0%
|
1
8.3%
|
| Red blood cell count decreased |
2
16.7%
|
0
0%
|
1
8.3%
|
0
0%
|
Adverse Events
| 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 | ||||||||
| Arm/Group Title | Placebo Vaccine Group | Low-dose C. Difficile Vaccine Group | Medium-dose C. Difficile Vaccine Group | High-dose C. Difficile Vaccine Group | ||||
| 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 (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
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%) | 0/12 (0%) | 2/12 (16.7%) | 0/12 (0%) | ||||
| Cardiac disorders | ||||||||
| Cardiomyopathy | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Gastrointestinal disorders | ||||||||
| Diverticulitis intestinal haemorrhagic | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
| Infections and infestations | ||||||||
| Pneumonia | 0/12 (0%) | 0 | 0/12 (0%) | 0 | 1/12 (8.3%) | 1 | 0/12 (0%) | 0 |
Other (Not Including 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 | 10/12 (83.3%) | 12/12 (100%) | 11/12 (91.7%) | 12/12 (100%) | ||||
| Cardiac disorders | ||||||||
| Cardiomyopathy | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Coronary artery disease | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Eye disorders | ||||||||
| Conjunctivitis | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Vitreous detachment | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal pain | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Constipation | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Diarrhoea | 1/12 (8.3%) | 2/12 (16.7%) | 2/12 (16.7%) | 1/12 (8.3%) | ||||
| Diverticulitis intestinal haemorrhagic | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Gastrooesophageal reflux disease | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Hyperchlorhydria | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Nausea | 1/12 (8.3%) | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Vomiting | 1/12 (8.3%) | 2/12 (16.7%) | 1/12 (8.3%) | 1/12 (8.3%) | ||||
| General disorders | ||||||||
| Asthenia | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Fatigue | 2/12 (16.7%) | 3/12 (25%) | 2/12 (16.7%) | 4/12 (33.3%) | ||||
| Induration | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Injection site bruising | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Injection site erythema | 1/12 (8.3%) | 3/12 (25%) | 1/12 (8.3%) | 3/12 (25%) | ||||
| Injection site haemorrhage | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Injection site induration | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Injection site nodule | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Injection site oedema | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Injection site pain | 3/12 (25%) | 8/12 (66.7%) | 4/12 (33.3%) | 8/12 (66.7%) | ||||
| Injection site pruritus | 0/12 (0%) | 1/12 (8.3%) | 1/12 (8.3%) | 1/12 (8.3%) | ||||
| Injection site reaction | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 1/12 (8.3%) | ||||
| Injection site swelling | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Injection site warmth | 0/12 (0%) | 2/12 (16.7%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Malaise | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Pain | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Pyrexia | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Infections and infestations | ||||||||
| Nasopharyngitis | 0/12 (0%) | 1/12 (8.3%) | 2/12 (16.7%) | 1/12 (8.3%) | ||||
| Pneumonia | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Upper respiratory tract infection | 0/12 (0%) | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Urinary tract infection | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Muscle strain | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Thermal burn | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Investigations | ||||||||
| Alanine aminotransferase increased | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Blood bilirubin increased | 0/12 (0%) | 0/12 (0%) | 2/12 (16.7%) | 1/12 (8.3%) | ||||
| Blood creatinine increased | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Blood potassium decreased | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Blood potassium increased | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 2/12 (16.7%) | ||||
| Blood pressure increased | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | ||||
| Blood urea decreased | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Blood urea increased | 1/12 (8.3%) | 0/12 (0%) | 3/12 (25%) | 2/12 (16.7%) | ||||
| Electrocardiogram ST T Change | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Eosinophil count increased | 4/12 (33.3%) | 5/12 (41.7%) | 3/12 (25%) | 5/12 (41.7%) | ||||
| Glucose urine | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | ||||
| Haematocrit decreased | 1/12 (8.3%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Haemoglobin decreased | 0/12 (0%) | 1/12 (8.3%) | 2/12 (16.7%) | 0/12 (0%) | ||||
| Platelet count decreased | 0/12 (0%) | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Platelet count increased | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Prostate examination abnormal | 0/6 (0%) | 0/4 (0%) | 0/7 (0%) | 1/5 (20%) | ||||
| Protein urine present | 0/12 (0%) | 0/12 (0%) | 3/12 (25%) | 2/12 (16.7%) | ||||
| Red blood cell count decreased | 2/12 (16.7%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Red blood cell count increased | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Red blood cells urine positive | 2/12 (16.7%) | 0/12 (0%) | 1/12 (8.3%) | 2/12 (16.7%) | ||||
| White blood cell count decreased | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| White blood cell count increased | 2/12 (16.7%) | 0/12 (0%) | 2/12 (16.7%) | 2/12 (16.7%) | ||||
| White blood cells urine positive | 3/12 (25%) | 1/12 (8.3%) | 5/12 (41.7%) | 6/12 (50%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Anorexia | 2/12 (16.7%) | 1/12 (8.3%) | 0/12 (0%) | 2/12 (16.7%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 2/12 (16.7%) | 5/12 (41.7%) | 1/12 (8.3%) | 1/12 (8.3%) | ||||
| Back pain | 1/12 (8.3%) | 3/12 (25%) | 0/12 (0%) | 2/12 (16.7%) | ||||
| Muscle spasms | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Myalgia | 2/12 (16.7%) | 4/12 (33.3%) | 1/12 (8.3%) | 4/12 (33.3%) | ||||
| Neck pain | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Pain in extremity | 1/12 (8.3%) | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 1/12 (8.3%) | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Headache | 2/12 (16.7%) | 3/12 (25%) | 2/12 (16.7%) | 1/12 (8.3%) | ||||
| Sinus headache | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | ||||
| Psychiatric disorders | ||||||||
| Insomnia | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Reproductive system and breast disorders | ||||||||
| Prostatitis | 0/6 (0%) | 0/4 (0%) | 1/7 (14.3%) | 0/5 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Cough | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Dry throat | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Pharyngolarygeal pain | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Postnasal drip | 0/12 (0%) | 1/12 (8.3%) | 0/12 (0%) | 0/12 (0%) | ||||
| Rhinorrhoea | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) | 1/12 (8.3%) | ||||
| Sinus congestion | 0/12 (0%) | 1/12 (8.3%) | 1/12 (8.3%) | 0/12 (0%) | ||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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. |
| Phone | |
| RegistryContactUs@sanofipasteur.com |
Responsible Party:
Sanofi
ClinicalTrials.gov Identifier:
NCT00214461
Other Study ID Numbers:
- H-030-009
First Posted:
Sep 22, 2005
Last Update Posted:
Apr 11, 2012
Last Verified:
Apr 1, 2012