Clostridium Infections
Conditions
Brief summary
The purpose of this study is to generate safety, reactogenicity (assessment of any expected or unexpected side effect of the vaccine) and immunogenicity (ability to induce an immune response) data for the development of a candidate Clostridium difficile (C. difficile) vaccine that would protect against primary cases of Clostridium difficile infection (CDI) and CDI recurrence. Clostridium difficile infection is a major cause of gastrointestinal illness with approximately 500,000 infections and the leading cause of gastroenteritis associated death with 29,000 deaths annually in the United States of America (USA). The emergence of extremely infectious varieties/types of C. difficile has contributed to increase the number and severity of CDI cases. In recent years, some countries (United Kingdom) have implemented hospital hygiene and other measures which resulted in significant reductions in the number of cases. The burden is, however, expected to remain significant until vaccination is available.
Interventions
BIOLOGICALC. difficile investigational vaccine based on the F2 antigen (GSK2904545A)
Subjects in CDIFF Ag 18 - 45 Years and CDIFF Ag 50 - 70 Years Groups will receive 2 or 3 doses (0.5 mL each) of CDIFF Ag vaccine. The vaccine will be administered intramuscularly in the deltoid, at a 0, 1-month dose interval. The third dose will be administered approximately 15 months after the second dose.
BIOLOGICALC. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B
Subjects in CDIFF Ag + AS01B 50 - 70 Years Group will receive 2 or 3 doses (0.5 mL each) of CDIFF Ag + AS01B vaccine. The vaccine will be administered intramuscularly in the deltoid, at a 0, 1-month dose interval. The third dose will be administered approximately 15 months after the second dose.
DRUGPlacebo
Subjects will receive 2 doses (0.5 mL each) of Placebo, administered intramuscularly in the deltoid, at a 0, 1-month dose interval.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This is a randomized, observer-blind and partial blind (only for third dose) study. Given the different appearance of the C.difficile investigational vaccines and placebo, double blinding is not possible, and the study will be conducted in an observer-blind manner. In an observer-blind study, the subject, the Contract Research Organization personnel, and the study center and Sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel may be aware of the treatment assignment. When all data up to Day 61 are available, a statistical analysis will be performed.This analysis may lead to the unblinding of some subjects.A statistician will be unblinded for the analysis.The study will be considered as partial blind from this point onwards. The Investigator and the subjects will not have access to the treatment allocation up to Day 390. After Day 390, only the subjects will remain fully blinded, while the Investigator will be partially blinded.
Intervention model description
A 4-step staggered design will be used to ensure maximum safety of the participating subjects: Step 1: Vaccination of approximately 20 subjects aged 18-45 years. Step 2: Vaccination of approximately 20 subjects aged 50-70 years. Step 3: Vaccination of approximately 30 subjects aged 50-70 years. An iSRC will review all accumulating safety data after Dose 1 and 2 in Steps 1 to 3. If considered appropriate to proceed, the next step will start. Step 4: Vaccination of approximately 70 subjects aged 50-70 years. An iSRC will review all accumulating safety data 3 weeks after the start of vaccination in Step 4 and then about every 3 weeks until all subjects have received Dose 1. In addition, the iSRC will review all safety data after Dose 2 and after that a subcohort of subjects will receive the third dose. If there are any safety concerns observed during SRT reviews post Dose 3, an ad hoc iSRC meeting will take place to review the unblinded safety data.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects who, in the opinion of the Investigator, can and will comply with the requirements of the protocol. 2. Written or witnessed/thumb print informed consent obtained from the subject prior to performance of any study specific procedure. 3. For Step 1 only: A male or female between, and including, 18-45 years of age at the time of the first vaccination. 4. For Steps 2, 3, and 4: A male or female between, and including, 50-70 years of age at the time of the first vaccination. 5. Healthy subjects as established by medical history and clinical examination before entering into the study. 6. Subjects free of any uncontrolled chronic illnesses as established by medical history and clinical examination before entering into the study. 7. Female subjects of non-childbearing potential may be enrolled in the study. * Non-childbearing potential is defined as premenarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy, or post-menopause. Female subjects of childbearing potential may be enrolled in the study, if the subject: * Has practiced adequate contraception for 30 days prior to vaccination, and * Has a negative urine pregnancy test on the day of vaccination, and * Has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.
Exclusion criteria
1. Health condition that, in the opinion of the Investigator, may interfere with optimal participation in the study or place the volunteer at increased risk of AEs. Study clinicians, in consultation with the Principal Investigator will use clinical judgment on a case by case basis to assess safety risks under this criterion. The Principal Investigator will consult with the Medical Monitor as appropriate. 2. Use of any investigational or nonregistered product other than the study vaccine(s) during the period starting 30 days before the first dose of study vaccine(s) (Day 29 to Day 1), or planned use during the study period. 3. Any medical condition that in the judgment of the Investigator would make IM injection unsafe and subjects under treatment with anticoagulant therapy. 4. Chronic administration of immunosuppressants or other immune modifying drugs during the period starting 3 months prior to the first vaccination. For corticosteroids, this will mean prednisone ≥ 5 milligrams per day (mg/day) (for adult subjects), or equivalent. Inhaled and topical steroids are allowed. 5. Administration of long acting immune modifying drugs at any time during the study period. 6. Administration of immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and treatments associated with organ or bone marrow transplantation or autoimmune disease. 7. Administration of immunoglobulins and/or any blood products during the period starting 3 months before the first vaccination of study treatment or planned administration during the study period. 8. Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 6 weeks before the first vaccination and ending 6 weeks after the last vaccination, with the exception of inactivated influenza vaccine which can be administered up to 14 days before or from 30 days after the last study vaccination. In case an emergency mass vaccination for an unforeseen public health threat (eg, a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly. 9. Planned administration of GSK's Herpes Zoster vaccine marketed as Shingrix or an adjuvanted recombinant varicella zoster virus envelope gE subunit vaccine (HZ/su) within 180 days before the first dose and within 180 days after the last dose of the study vaccine. 10. Planned elective surgery during the study period. 11. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product. 12. Body mass index \< 19 kg/m\^2 or ≥ 35 kg/m\^2. 13. Clinically relevant physical examination abnormalities. 14. For subjects aged 18 - 45 years, Grade 2 or higher abnormal hematological, biochemical, and urinary parameters. 15. For subjects aged 50 - 70 years, Grade 3 or higher abnormal hematological, biochemical, and urinary parameters. 16. Documentation of current or prior episode of CDI. 17. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). 18. Recurrent history or uncontrolled neurological disorders or seizures. 19. Family history of congenital or hereditary immunodeficiency. 20. History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines. 21. Acute disease and/or fever at the time of enrollment. * Fever is defined as temperature ≥ 38.0°C/100.4°F. The preferred location for measuring temperature in this study will be the oral cavity. * Subjects with a minor illness, without fever, may be enrolled at the discretion of the Investigator. 22. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, or renal functional abnormality, as determined by physical examination or laboratory screening tests. 23. Pregnant or lactating female. 24. History of intestinal bleeding or history of diverticular intestinal bleeding. 25. Surgery for gastrointestinal malignancy in the period starting 3 months prior to the first vaccination. 26. History of chronic alcohol consumption and/or drug abuse as deemed by the Investigator to render the potential subject unable/unlikely to provide accurate safety reports. 27. Female planning to become pregnant or planning to discontinue contraceptive precautions. 28. Documented human immunodeficiency virus positive subject, known positivity for the surface antigen of the hepatitis B virus or known positive serologic test for the hepatitis C virus. 29. Involvement in the planning and/or conduct of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | At Day 670 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccination | Assessed solicited local symptoms are pain at injection site, redness at injection site and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that pre-vents normal every day activities. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater (\>) than 100 millimeters (mm). |
| Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccination | Assessed solicited general symptoms are fatigue, fever \[defined as oral temperature equal to or higher than (\>=) 38 degrees Celsius (°C)\], gastrointestinal symptoms (nausea, vomiting, diarrhea, and/or abdominal pain), headache, myalgia, shivering and arthralgia. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevents normal, everyday activities. Grade 3 fever = oral temperature higher (\>) than 39.0°C. Related symptom = symptom assessed by the investigator as causally related to the study vaccination. Grade 3 related symptom = Grade 3 symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination | An unsolicited AE is any adverse event reported in addition to those solicited during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider) or were of concern to the subjects. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevents normal, everyday activities. Related symptom = symptom assessed by the investigator as causally related to the study vaccination. Grade 3 related symptom = Grade 3 symptom assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 1 up to and including Day 390 (Epoch 001) | An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | During the whole study period (from Day 1 up to Day 390 [for subjects receiving 2 vaccine doses] and from Day 1 up to Day 670 [for subjects receiving 3 vaccine doses]) | pIMDs are a subset of adverse events of specific interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. |
| Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | At Screening (from Day -15 up to Day -1 [for subjects receiving 2 vaccine doses] and at Day 476 [for subjects receiving 3 vaccine doses]) | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine, C-reactive protein and urate/uric acid) and urinary (protein, glucose and red blood cells) parameters are assessed. C-reactive protein is only assessed during the screening visit. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | At Day 8 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | At Day 31 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | At Day 38 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | At Day 180 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | At Day 390 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | At Day 476 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. |
| Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | At Day 491 | Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | At Day 1, Day 31, Day 61, Day 180, Day 390, Day 491, Day 521 and Day 670 | Serum neutralizing anti-Toxin A and anti-Toxin B antibody titers are presented as Geometric Mean Titers (GMTs), as measured by TNA. |
Countries
Belgium
Participant flow
Pre-assignment details
Participants in this study were randomized in 5 groups on 2 age categories. After study interventions, as pre-assigned in protocol, the participants were followed up for safety, reactogenicity, and immunogenicity analysis until the end of the study.
Participants by arm
| Arm | Count |
|---|---|
| CDIFF Ag 18 - 45 Years Group Healthy male and female subjects, aged between and including 18 and 45 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. | 10 |
| Placebo 18 - 45 Years Group Healthy male and female subjects, aged between and including 18 and 45 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. | 10 |
| CDIFF Ag 50 - 70 Years Group Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF antigen (Ag) vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. | 45 |
| CDIFF Ag + AS01B 50 - 70 Years Group Healthy male and female subjects, aged between and including 50 and 70 years old, who receive CDIFF Ag + AS01B adjuvant vaccine administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. A third dose of CDIFF Ag + AS01B adjuvant vaccine was administered to a set of participants in this group, approximately 15 months after the administration of the second dose. | 45 |
| Placebo 50 - 70 Years Group Healthy male and female subjects, aged between and including 50 and 70 years old, who receive Placebo administered intramuscularly in the deltoid, according to a 0, 1-month vaccination schedule. | 30 |
| Total | 140 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Consent withdrawal, not due to adverse event | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Eligibility criteria not fulfilled | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | CDIFF Ag 18 - 45 Years Group | Placebo 18 - 45 Years Group | CDIFF Ag 50 - 70 Years Group | CDIFF Ag + AS01B 50 - 70 Years Group | Placebo 50 - 70 Years Group | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 32.7 Years STANDARD_DEVIATION 6.8 | 31.5 Years STANDARD_DEVIATION 7.7 | 60.7 Years STANDARD_DEVIATION 6.1 | 60.8 Years STANDARD_DEVIATION 6 | 58.9 Years STANDARD_DEVIATION 6.2 | 56.2 Years STANDARD_DEVIATION 11.7 |
| Race/Ethnicity, Customized White | 10 Participants | 10 Participants | 45 Participants | 45 Participants | 30 Participants | 140 Participants |
| Sex: Female, Male Female | 5 Participants | 5 Participants | 30 Participants | 30 Participants | 20 Participants | 90 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 15 Participants | 15 Participants | 10 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 | 0 / 45 | 0 / 45 | 0 / 30 |
| other Total, other adverse events | 8 / 10 | 6 / 10 | 45 / 45 | 32 / 45 | 23 / 30 |
| serious Total, serious adverse events | 0 / 10 | 1 / 10 | 3 / 45 | 3 / 45 | 0 / 30 |
Outcome results
Primary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose
Assessed solicited local symptoms are pain at injection site, redness at injection site and swelling at injection site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest, pain that pre-vents normal every day activities. Grade 3 redness/swelling = redness/swelling with a maximum diameter greater (\>) than 100 millimeters (mm).
Time frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccination
Population: The analysis is performed on the Solicited Safety Set, which included all subjects who received at least one dose of the study vaccine and for whom solicited safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 2 | 2 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 2 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 1 | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 2 | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 1 | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 2 | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 1 | 40 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 2 | 38 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 2 | 19 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 2 | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 1 | 8 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 1 | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 2 | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 1 | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Swelling, after Dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Pain, after Dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Erythema, after Dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Pain, after Dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Grade 3 Swelling, after Dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms, After Each Vaccine Dose | Any Erythema, after Dose 1 | 0 Participants |
Primary
Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose
Assessed solicited general symptoms are fatigue, fever \[defined as oral temperature equal to or higher than (\>=) 38 degrees Celsius (°C)\], gastrointestinal symptoms (nausea, vomiting, diarrhea, and/or abdominal pain), headache, myalgia, shivering and arthralgia. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevents normal, everyday activities. Grade 3 fever = oral temperature higher (\>) than 39.0°C. Related symptom = symptom assessed by the investigator as causally related to the study vaccination. Grade 3 related symptom = Grade 3 symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 7-day follow-up period (from the day of vaccination up to 6 subsequent days) after each vaccination
Population: The analysis is performed on the Solicited Safety Set, which included all subjects who received at least one dose of the study vaccine and for whom solicited safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 1 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 1 | 2 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 1 | 4 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 1 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 1 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 1 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 2 | 2 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 2 | 2 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 1 | 2 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 1 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 2 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 1 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 2 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 1 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 2 | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 2 | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 2 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 1 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 1 | 3 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 1 | 2 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 1 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 1 | 2 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 1 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 1 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 2 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 2 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 2 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 2 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 1 | 2 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 1 | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 1 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 2 | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 2 | 5 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 2 | 6 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 1 | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 1 | 8 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 1 | 12 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 1 | 8 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 2 | 4 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 2 | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 2 | 4 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 2 | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 1 | 5 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 2 | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 2 | 8 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 2 | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 1 | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 1 | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 2 | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 1 | 9 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 1 | 9 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 2 | 8 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 2 | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 1 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 2 | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 1 | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 1 | 16 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 2 | 26 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 1 | 7 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 2 | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 2 | 26 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 1 | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 2 | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 2 | 12 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 1 | 18 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 2 | 11 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 2 | 19 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 2 | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 2 | 19 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 2 | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 2 | 19 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 2 | 18 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 1 | 7 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 2 | 19 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 2 | 19 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 2 | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 1 | 7 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 2 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 2 | 9 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 2 | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 1 | 5 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 1 | 20 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 1 | 5 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 1 | 5 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 2 | 5 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 1 | 19 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 1 | 7 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 1 | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 2 | 9 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 1 | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Headache, after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 2 | 6 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 1 | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 2 | 5 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 2 | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 2 | 7 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Fatigue, after dose 1 | 7 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 2 | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 1 | 4 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 1 | 6 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Fatigue, after dose 1 | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Shivering, after dose 1 | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Arthralgia, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 2 | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Fatigue, after dose 1 | 7 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Shivering, after dose 2 | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Arthralgia, after dose 1 | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Myalgia, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 1 | 4 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Shivering, after dose 2 | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Gastrointestinal symptoms, after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Myalgia, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 1 | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Temperature (C), after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Gastrointestinal symptoms, after dose 1 | 5 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Gastrointestinal symptoms, after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Gastrointestinal symptoms, after dose 1 | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Arthralgia, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Temperature (C), after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Shivering, after dose 1 | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Fatigue, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Myalgia, after dose 2 | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 Myalgia, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Arthralgia, after dose 1 | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Temperature (C), after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Headache, after dose 2 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Grade 3 related Temperature (C), after dose 1 | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Any Headache, after dose 1 | 6 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related and Grade 3 Related Solicited General Symptoms, After Each Vaccine Dose | Related Headache, after dose 2 | 6 Participants |
Primary
Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs)
An unsolicited AE is any adverse event reported in addition to those solicited during the clinical study. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited adverse event. Potential unsolicited AEs may be medically attended (defined as symptoms or illnesses requiring hospitalization, or emergency room visit, or visit to/by a health care provider) or were of concern to the subjects. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination. Grade 3 symptom = symptom that prevents normal, everyday activities. Related symptom = symptom assessed by the investigator as causally related to the study vaccination. Grade 3 related symptom = Grade 3 symptom assessed by the investigator as causally related to the study vaccination.
Time frame: During the 30-day follow-up period (from the day of vaccination up to 29 subsequent days) after any vaccination
Population: The analysis is performed on the Exposed Set, which included all subjects who received at least one dose of the study vaccine and for whom safety data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Medically attended unsolicited AEs | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 3 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 related unsolicited AEs | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Medically attended unsolicited AEs | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 related unsolicited AEs | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Medically attended unsolicited AEs | 8 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 22 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 related unsolicited AEs | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 27 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 8 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 related unsolicited AEs | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Medically attended unsolicited AEs | 14 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 unsolicited AEs | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Related unsolicited AEs | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Grade 3 related unsolicited AEs | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Medically attended unsolicited AEs | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Any, Grade 3, Related, Grade 3 Related and Medically Attended Unsolicited Adverse Events (AEs) | Any unsolicited AEs | 11 Participants |
Primary
Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180
Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities.
Time frame: At Day 180
Population: The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Above Normal Range) | 2 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Below Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Above Normal Range) | 2 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Below Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Below Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Below Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Above Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Below Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Above Normal Range) | 4 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Above Normal Range) | 5 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Above Normal Range) | 9 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Below Normal Range) | 5 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Above Normal Range) | 7 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Below Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Below Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Above Normal Range) | 5 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Alanine Aminotransferase, at Day 180 (Above Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Aspartate Aminotransferase, at Day 180 (Above Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Hemoglobin, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | White Blood Cells, at Day 180 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Urate, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Platelets, at Day 180 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 180 | Creatinine, at Day 180 (Above Normal Range) | 0 Participants |
Primary
Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31
Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities.
Time frame: At Day 31
Population: The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Above Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Above Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Below Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Above Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Above Normal Range) | 6 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Below Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Above Normal Range) | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Above Normal Range) | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Above Normal Range) | 8 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Below Normal Range) | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Above Normal Range) | 9 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Above Normal Range) | 5 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Below Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Urate, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | White Blood Cells, at Day 31 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Creatinine, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Alanine Aminotransferase, at Day 31 (Above Normal Range) | 4 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Platelets, at Day 31 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Aspartate Aminotransferase, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 31 | Hemoglobin, at Day 31 (Above Normal Range) | 1 Participants |
Primary
Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38
Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities.
Time frame: At Day 38
Population: The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Above Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Below Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Above Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Above Normal Range) | 9 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Above Normal Range) | 9 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Above Normal Range) | 8 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Above Normal Range) | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Aspartate Aminotransferase, at Day 38 (Above Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | White Blood Cells, at Day 38 (Below Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Urate, at Day 38 (Above Normal Range) | 5 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Creatinine, at Day 38 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Hemoglobin, at Day 38 (Below Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Alanine Aminotransferase, at Day 38 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 38 | Platelets, at Day 38 (Below Normal Range) | 0 Participants |
Primary
Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390
Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities.
Time frame: At Day 390
Population: The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Below Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Below Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Above Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Below Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Below Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Above Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Below Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Above Normal Range) | 6 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Below Normal Range) | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Above Normal Range) | 8 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Above Normal Range) | 7 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Below Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Above Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Above Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Platelets, at Day 390 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Above Normal Range) | 5 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Urate, at Day 390 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | White Blood Cells, at Day 390 (Below Normal Range) | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Hemoglobin, at Day 390 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Aspartate Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Above Normal Range) | 4 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 390 | Alanine Aminotransferase, at Day 390 (Below Normal Range) | 0 Participants |
Primary
Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476
Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities.
Time frame: At Day 476
Population: The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Above Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Above Normal Range) | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Above Normal Range) | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Alanine Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Hemoglobin, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Urate, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Creatinine, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Aspartate Aminotransferase, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | Platelets, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 476 | White Blood Cells, at Day 476 (Above Normal Range) | 0 Participants |
Primary
Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491
Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities.
Time frame: At Day 491
Population: The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Below Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Above Normal Range) | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Above Normal Range) | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Above Normal Range) | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Platelets, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Aspartate Aminotransferase, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Hemoglobin, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Urate, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Creatinine, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | White Blood Cells, at Day 491 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 491 | Alanine Aminotransferase, at Day 491 (Above Normal Range) | 0 Participants |
Primary
Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670
Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities.
Time frame: At Day 670
Population: The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Below Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Below Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Above Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Alanine Aminotransferase, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Platelets, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Hemoglobin, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Urate, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Aspartate Aminotransferase, at Day 670 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | White Blood Cells, at Day 670 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 670 | Creatinine, at Day 670 (Above Normal Range) | 0 Participants |
Primary
Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8
Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine and urate/uric acid) parameters are assessed. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities.
Time frame: At Day 8
Population: The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Below Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Above Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Below Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Above Normal Range) | 5 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Above Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Above Normal Range) | 10 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Above Normal Range) | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Above Normal Range) | 9 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Above Normal Range) | 6 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Below Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Hemoglobin, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Above Normal Range) | 6 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Urate, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Alanine Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Platelets, at Day 8 (Below Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Creatinine, at Day 8 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Above Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | Aspartate Aminotransferase, at Day 8 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological and Biochemical Laboratory Abnormalities at Day 8 | White Blood Cells, at Day 8 (Above Normal Range) | 1 Participants |
Primary
Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening
Hematological (white blood cells, platelet count, hemoglobin level), biochemical (alanine aminotransferase, aspartate aminotransferase, creatinine, C-reactive protein and urate/uric acid) and urinary (protein, glucose and red blood cells) parameters are assessed. C-reactive protein is only assessed during the screening visit. Grades are based on the local laboratory normal ranges and derived from the FDA Toxicity Grading Scale for laboratory abnormalities.
Time frame: At Screening (from Day -15 up to Day -1 [for subjects receiving 2 vaccine doses] and at Day 476 [for subjects receiving 3 vaccine doses])
Population: The analysis is performed on the Enrolled Set, which included all subjects who signed the Informed Consent Form (ICF).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Above Normal Range) | 2 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Above Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Above Normal Range) | 0 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Below Normal Range) | 1 Participants |
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Above Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Below Normal Range) | 1 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Above Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Below Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Above Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Above Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Above Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Day 476 (Above Normal Range) | 4 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Day 476 (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Day 476 (Above Normal Range) | 3 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Above Normal Range) | 2 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Above Normal Range) | 6 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Above Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Above Normal Range) | 9 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Below Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Above Normal Range) | 8 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Day 476 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Day 476 (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Above Normal Range) | 4 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Day 476 (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Above Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Day 476 (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Day 476 (Below Normal Range) | 1 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Below Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Day 476 (Above Normal Range) | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Above Normal Range) | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Above Normal Range) | 0 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Day 476 (Above Normal Range) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Above Normal Range) | 2 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Above Normal Range) | 4 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Above Normal Range) | 4 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Above Normal Range) | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Screening (Above Normal Range) | 4 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Platelets, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Screening (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Screening (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | White Blood Cells, at Screening (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | C Reactive Protein, at Screening (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Screening (Above Normal Range) | 1 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Aspartate Aminotransferase, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Creatinine, at Screening (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Above Normal Range) | 5 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Hemoglobin, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Day 476 (Below Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Alanine Aminotransferase, at Day 476 (Above Normal Range) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Hematological, Biochemical, and Urinary Laboratory Abnormalities at Screening | Urate, at Screening (Below Normal Range) | 0 Participants |
Primary
Number of Subjects With Potential Immune-mediated Diseases (pIMDs)
pIMDs are a subset of adverse events of specific interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.
Time frame: During the whole study period (from Day 1 up to Day 390 [for subjects receiving 2 vaccine doses] and from Day 1 up to Day 670 [for subjects receiving 3 vaccine doses])
Population: The analysis is performed on the Exposed Set, which included all subjects who received at least one dose of the study vaccine and for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 2 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Potential Immune-mediated Diseases (pIMDs) | 0 Participants |
Primary
Number of Subjects With Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, represents a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 1 up to and including Day 390 (Epoch 001)
Population: The analysis is performed on the Exposed Set, which included all subjects who received at least one dose of the study vaccine and for whom safety data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Placebo 18 - 45 Years Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| CDIFF Ag 50 - 70 Years Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| CDIFF Ag + AS01B 50 - 70 Years Group | Number of Subjects With Serious Adverse Events (SAEs) | 3 Participants |
| Placebo 50 - 70 Years Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
Secondary
Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA)
Serum neutralizing anti-Toxin A and anti-Toxin B antibody titers are presented as Geometric Mean Titers (GMTs), as measured by TNA.
Time frame: At Day 1, Day 31, Day 61, Day 180, Day 390, Day 491, Day 521 and Day 670
Population: The analysis was performed on the Per-Protocol Set for analysis of immunogenicity, which included all subjects who received one dose of the study treatment to which they were randomized and have post-vaccination immunogenicity data available at the specified time point, minus the subjects with protocol deviations that lead to exclusion.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 180 | 55.15 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 390 | 42.18 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 180 | 35.92 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 61 | 42.68 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 390 | 17.14 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 31 | 50.11 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 180 | 16.85 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 61 | 19.76 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 1 | 9.26 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 1 | 7.24 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 31 | 55.52 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 31 | 17.58 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 1 | 9.13 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 61 | 108.68 Titer |
| CDIFF Ag 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 390 | 28.93 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 180 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 180 | 6.00 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 390 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 1 | 6.00 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 61 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 390 | 6.00 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 1 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 31 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 31 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 180 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 390 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 1 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 31 | 6.00 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 61 | 7.50 Titer |
| Placebo 18 - 45 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 61 | 6.00 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 31 | 8.87 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 390 | 12.46 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 491 | 13.17 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 1 | 8.37 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 180 | 11.81 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 390 | 11.71 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 491 | 14.81 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 1 | 6.00 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 61 | 18.05 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 180 | 15.06 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 521 | 477.30 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 670 | 174.29 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 1 | 9.17 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 31 | 23.61 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 61 | 27.67 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 180 | 21.08 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 390 | 18.24 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 491 | 37.00 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 521 | 207.45 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 670 | 101.18 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 31 | 13.56 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 61 | 15.19 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 521 | 22.66 Titer |
| CDIFF Ag 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 670 | 19.57 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 390 | 101.46 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 390 | 107.86 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 390 | 19.00 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 521 | 34.48 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 1 | 14.18 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 180 | 139.30 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 521 | 8276.96 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 491 | 73.63 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 61 | 20.61 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 31 | 57.12 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 180 | 20.63 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 491 | 107.56 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 180 | 207.62 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 521 | 3590.97 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 61 | 119.54 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 491 | 17.21 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 670 | 530.61 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 31 | 32.79 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 1 | 11.71 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 61 | 407.04 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 1 | 6.64 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 670 | 1636.90 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 670 | 26.67 Titer |
| CDIFF Ag + AS01B 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 31 | 20.86 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 1 | 7.78 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 61 | 6.22 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 180 | 9.35 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 31 | 6.74 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 390 | 9.30 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 180 | 8.55 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 61 | 8.73 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 1 | 6.25 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 31 | 7.78 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 390 | 8.56 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 1 | 8.31 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ HCT-116, at Day 31 | 8.83 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 390 | 6.53 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin A neutralizing antibody titers/ HT-29, at Day 180 | 6.15 Titer |
| Placebo 50 - 70 Years Group | Serum Neutralizing Anti-Toxin A and Anti-Toxin B Antibody Titers, as Measured by Toxin Neutralization Assay (TNA) | Anti-toxin B neutralizing antibody titers/ IMR-90, at Day 61 | 7.50 Titer |