Clostridium Infections
Conditions
Keywords
Clostridium difficile
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.
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.
Interventions
BIOLOGICALVaccine diluent buffer (Placebo)
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
BIOLOGICALC. difficile toxoid vaccine (2 µg)
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
BIOLOGICALC. difficile toxoid vaccine (10 µg)
0.5 mL, Intramuscular on Day 0, Day 28 and Day 56, respectively.
BIOLOGICALC. difficile toxoid vaccine (50 µg)
0.5 mL, Intramuscular on Day 0, Day 28, and Day 56, respectively.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
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 details
A total of 48 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Vaccine Group Participants who received a dose of placebo, on Days 0, 28, and 56, respectively. | 12 |
| Low-dose C. Difficile Vaccine Group Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively. | 12 |
| Medium-dose C. Difficile Vaccine Group Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively. | 12 |
| High-dose C. Difficile Vaccine Group Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively. | 12 |
| Total | 48 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Low-dose C. Difficile Vaccine Group | Medium-dose C. Difficile Vaccine Group | Placebo Vaccine Group | High-dose C. Difficile Vaccine Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 12 Participants | 12 Participants | 12 Participants | 48 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 72.2 Years STANDARD_DEVIATION 5.32 | 75.5 Years STANDARD_DEVIATION 6.47 | 69.0 Years STANDARD_DEVIATION 3.59 | 68.9 Years STANDARD_DEVIATION 4.32 | 71.4 Years STANDARD_DEVIATION 5.6 |
| Region of Enrollment United States | 12 participants | 12 participants | 12 participants | 12 participants | 48 participants |
| Sex: Female, Male Female | 8 Participants | 5 Participants | 6 Participants | 7 Participants | 26 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 6 Participants | 5 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 12 | 12 / 12 | 11 / 12 | 12 / 12 |
| serious Total, serious adverse events | 0 / 12 | 0 / 12 | 2 / 12 | 0 / 12 |
Outcome results
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
Population: Safety assessments were on the safety population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Vaccine Group | 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. | Protein urine present | 0 Participants |
| Placebo Vaccine Group | 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. | White blood cell count increased | 2 Participants |
| Placebo Vaccine Group | 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. | Injection site erythema | 1 Participants |
| Placebo Vaccine Group | 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. | Blood potassium increased | 0 Participants |
| Placebo Vaccine Group | 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. | Diarrhoea | 1 Participants |
| Placebo Vaccine Group | 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. | Blood urea increased | 1 Participants |
| Placebo Vaccine Group | 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. | Headache | 2 Participants |
| Placebo Vaccine Group | 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. | White blood cells urine positive | 3 Participants |
| Placebo Vaccine Group | 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. | Back pain | 1 Participants |
| Placebo Vaccine Group | 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. | Injection site warmth | 0 Participants |
| Placebo Vaccine Group | 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. | Blood bilirubin increased | 0 Participants |
| Placebo Vaccine Group | 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. | Injection site pain | 3 Participants |
| Placebo Vaccine Group | 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. | Fatigue | 2 Participants |
| Placebo Vaccine Group | 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. | Eosinophil count increased | 4 Participants |
| Placebo Vaccine Group | 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. | Nasopharyngitis | 0 Participants |
| Placebo Vaccine Group | 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. | Red blood cells urine positive | 2 Participants |
| Placebo Vaccine Group | 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. | Myalgia | 2 Participants |
| Placebo Vaccine Group | 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. | Red blood cell count decreased | 2 Participants |
| Placebo Vaccine Group | 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. | Anorexia | 2 Participants |
| Placebo Vaccine Group | 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. | Vomiting | 1 Participants |
| Placebo Vaccine Group | 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. | Arthralgia | 2 Participants |
| Placebo Vaccine Group | 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. | Haemoglobin decreased | 0 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Nasopharyngitis | 1 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Injection site pain | 8 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Eosinophil count increased | 5 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | White blood cells urine positive | 1 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Fatigue | 3 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Myalgia | 4 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Arthralgia | 5 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Injection site erythema | 3 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Headache | 3 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Back pain | 3 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Blood urea increased | 0 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Diarrhoea | 2 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | White blood cell count increased | 0 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Protein urine present | 0 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Vomiting | 2 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Anorexia | 1 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Red blood cells urine positive | 0 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Blood bilirubin increased | 0 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Blood potassium increased | 0 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Haemoglobin decreased | 1 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Injection site warmth | 2 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Red blood cell count decreased | 0 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Nasopharyngitis | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Protein urine present | 3 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | White blood cells urine positive | 5 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Myalgia | 1 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Blood bilirubin increased | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Red blood cell count decreased | 1 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Anorexia | 0 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Injection site pain | 4 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Blood potassium increased | 1 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Haemoglobin decreased | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Headache | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Arthralgia | 1 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Back pain | 0 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Injection site warmth | 0 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Red blood cells urine positive | 1 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Eosinophil count increased | 3 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Blood urea increased | 3 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | White blood cell count increased | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Injection site erythema | 1 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Fatigue | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Diarrhoea | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Vomiting | 1 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Diarrhoea | 1 Participants |
| High-dose C. Difficile Vaccine Group | 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. | White blood cell count increased | 2 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Haemoglobin decreased | 0 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Protein urine present | 2 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Myalgia | 4 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Injection site pain | 8 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Vomiting | 1 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Anorexia | 2 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Fatigue | 4 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Red blood cells urine positive | 2 Participants |
| High-dose C. Difficile Vaccine Group | 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. | White blood cells urine positive | 6 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Nasopharyngitis | 1 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Injection site warmth | 1 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Blood bilirubin increased | 1 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Eosinophil count increased | 5 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Headache | 1 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Blood potassium increased | 2 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Back pain | 2 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Injection site erythema | 3 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Blood urea increased | 2 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Red blood cell count decreased | 0 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Arthralgia | 1 Participants |
Secondary
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.
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
Population: Serum anti-toxin levels were assessed in the fully evaluable (Per-Protocol) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo Vaccine Group | 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. | Toxin A: Day 14 | 0 Participants |
| Placebo Vaccine Group | 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. | Toxin A: Day 28 | 0 Participants |
| Placebo Vaccine Group | 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. | Toxin A: Day 56 | 0 Participants |
| Placebo Vaccine Group | 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. | Toxin A: Day 70 | 0 Participants |
| Placebo Vaccine Group | 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. | Toxin A: Day 236 | 0 Participants |
| Placebo Vaccine Group | 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. | Toxin B: Day 14 | 0 Participants |
| Placebo Vaccine Group | 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. | Toxin B: Day 28 | 0 Participants |
| Placebo Vaccine Group | 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. | Toxin B: Day 56 | 0 Participants |
| Placebo Vaccine Group | 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. | Toxin B: Day 70 | 0 Participants |
| Placebo Vaccine Group | 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. | Toxin B: Day 236 | 0 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 56 | 6 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 70 | 7 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 70 | 11 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 236 | 3 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 14 | 2 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 28 | 3 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 236 | 3 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 56 | 4 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 14 | 0 Participants |
| Low-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 28 | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 56 | 4 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 28 | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 236 | 1 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 14 | 1 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 70 | 9 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 14 | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 70 | 5 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 28 | 2 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 236 | 4 Participants |
| Medium-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 56 | 8 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 236 | 5 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 56 | 5 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 14 | 4 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 236 | 3 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 28 | 5 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 28 | 4 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 56 | 11 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 70 | 11 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin A: Day 14 | 3 Participants |
| High-dose C. Difficile Vaccine Group | 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. | Toxin B: Day 70 | 8 Participants |