Clostridium Difficile Associated Disease
Conditions
Keywords
Clostridium difficile, Vaccine.
Brief summary
This study will investigate a Clostridium difficile vaccine in healthy adults aged 65-85 years. Each subject will initially receive 3 doses of vaccine on 1 of 2 vaccination schedules. The study will assess the safety and tolerability of the vaccine as well as the subjects' immune response to the vaccine. One year after the third dose subjects that did not receive placebo will be randomized to receive a fourth dose. Subjects will be followed for up to 4 years after their third vaccination.
Interventions
BIOLOGICALClostridium difficile Vaccine
0.5 mL intramuscular injection.
BIOLOGICALPlacebo
0.5 mL intramuscular injection
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male and female subjects * Aged 65 to 85 years Additional Inclusion Criteria for the extension Stage: * Receipt of all 3 doses of C difficile vaccine (100 µg or 200 µg antigen dose level) in the original portion of the study.
Exclusion criteria
* Proven or suspected prior episode of Clostridium difficile associated diarrhea * Unstable chronic medical condition * Disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine * Serious chronic disorders * Congenital or acquired immunodeficiency disorders * Rheumatologic disorders or other illnesses requiring chronic treatment with known immunosuppressant medications. * Active or treated leukemia or lymphoma or bone marrow disorder * Any contraindication to vaccination or vaccine components including previous anaphylactic reaction to any vaccine or vaccine-related components Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37 | Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen) | Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay. |
| Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Month 7 | Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen) | Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay. |
| Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 37 | Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen) | Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay. |
| Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Month 7 | Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen) | Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay. |
| Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 37 | Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen) | Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay. |
| Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Month 7 | Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen) | Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay. |
| Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | within 7 days After Vaccination 1 | Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2)(interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 centimeter \[cm\]), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). |
| Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | within 14 days After Vaccination 1 | Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). |
| Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | within 14 days After Vaccination 2 | Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). |
| Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | within 14 days after Vaccination 2 | Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). |
| Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | within 14 days after Vaccination 3 | Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). |
| Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | within 14 days after Vaccination 3 | Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). |
| Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | within 7 days after Vaccination 1 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 degree Celsius (C)), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization). |
| Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | within 14 days after Vaccination 1 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization). |
| Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | within 14 days after Vaccination 2 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization). |
| Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | within 14 days after Vaccination 2 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization). |
| Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | within 14 days after Vaccination 3 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization). |
| Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | within 14 days after Vaccination 3 | Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization). |
| Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs) | From Vaccination 1 up to 28 days after Vaccination 3 (Day 58) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. |
| Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs) | From Vaccination 1 up to 28 days after Vaccination 3 (Day 208) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. |
| Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs) | From Vaccination 1 up to 6 months after Vaccination 3 (Month 7) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events between first dose of study drug and up to 6 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. |
| Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs) | From Vaccination 1 up to 6 months after Vaccination 3 (Month 12) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events between first dose of study drug and up to 6 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay. |
| Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay. |
| Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay. |
| Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay. |
| Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | GMC of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations. |
| Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Extension Stage Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations. |
| Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | GMC of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations. |
| Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations. |
| Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | GMFR in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. |
| Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | GMFR in toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. |
| Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | GMFR in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. |
| Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | GMFR in toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. |
| Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin A antibodies were measured using neutralization assay. |
| Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin B antibodies were measured using neutralization assay. |
| Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin A and B antibodies were measured using neutralization assay. |
| Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin A antibodies were measured using neutralization assay. |
| Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin B antibodies were measured using neutralization assay. |
| Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin A and B antibodies were measured using neutralization assay. |
| Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Within 14 days after Vaccination 4 | Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2) (interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). Any local reaction referred to any injection site pain, any swelling, or any redness. |
| Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Within 14 days after Vaccination 4 | Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2) (interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). Any local reaction referred to any injection site pain, any swelling, or any redness. |
| Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Within 14 days after Vaccination 4 | Systemic events included following events: Fever was graded as mild (38.0 to 38.4 degree C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade (G) 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration)/grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and G4 (hospitalization). Headache, fatigue, new/worsening muscle pain and new/worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and G4 (hospitalization). Any systemic event referred to any fever \>= 38.0 degree C, any vomiting, any diarrhea, any headache, any fatigue, any new/worsening muscle pain, or any new or worsening joint pain. |
| Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Toxin A antibodies were measured using neutralization assay. |
| Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | From Vaccination 4 up to 28 days after Vaccination 4 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent adverse events are events from dose 4 of study drug to 28 days after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state. |
| Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | From Vaccination 4 up to 28 days after Vaccination 4 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent adverse events are events from dose 4 of study drug to 28 days after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state. |
| Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | From Vaccination 4 up to 6 months after Vaccination 4 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events from dose 4 of study drug to 6 months after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state. |
| Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | From Vaccination 4 up to 6 months after Vaccination 4 | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events from dose 4 of study drug to 6 months after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state. |
| Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | within 14 days after Vaccination 4 | Systemic events included following events: Fever was graded as mild (38.0 to 38.4 degree C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade (G) 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration)/grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and G4 (hospitalization). Headache, fatigue, new/worsening muscle pain and new/worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and G4 (hospitalization). Any systemic event referred to any fever \>= 38.0 degree C, any vomiting, any diarrhea, any headache, any fatigue, any new/worsening muscle pain, or any new or worsening joint pain. |
| Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Toxin B antibodies were measured using neutralization assay. |
| Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Toxin A and toxin B antibodies were measured using neutralization assay. |
| Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Toxin A antibodies were measured using neutralization assay. |
| Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Toxin B antibodies were measured using neutralization assay. |
| Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Toxin A and toxin B antibodies were measured using neutralization assay. |
| Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Geometric mean concentration (GMC) of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. Confidence interval (CI) for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations. |
| Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations. |
| Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | GMC of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations. |
| Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations. |
| Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Geometric mean fold rise (GMFR) in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. |
| Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | GMFR in toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. |
| Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | GMFR in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. |
| Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | GMFR for toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. |
| Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Toxin A antibodies were measured using neutralization assay. |
| Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Toxin B antibodies were measured using neutralization assay. |
| Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Toxin A and toxin B antibodies were measured using neutralization assay. |
| Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Toxin A antibodies were measured using neutralization assay. |
| Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Toxin A antibodies were measured using neutralization assay. |
| Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Toxin A and toxin B antibodies were measured using neutralization assay. |
| Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay. |
| Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4 | Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay. |
Countries
United States
Participant flow
Pre-assignment details
Participants initially randomized in the month and day regimens who received the first 3 doses of Clostridium difficile vaccine (100 micro gram (mcg) or 200 mcg) were enrolled into the extension stage.
Participants by arm
| Arm | Count |
|---|---|
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen Participants received 100 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination | 182 |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen Participants received 200 mcg of Clostridium difficile vaccine intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination. | 184 |
| Placebo: Day 1, 8 and 30 Regimen Participants received placebo saline intramuscularly on Day 1, 8 and 30 visits. Participants were followed up to 12 months after the last vaccination. | 61 |
| Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen Participants received 100 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the third vaccination. | 183 |
| Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen Participants received 200 mcg of Clostridium difficile vaccine intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination. | 183 |
| Placebo: Month 0, 1 and 6 Regimen Participants received placebo saline intramuscularly at Month 0 (Day 1), 1 and 6 visits. Participants were followed up to 12 months after the last vaccination. | 61 |
| Total | 854 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Extension Stage (Vaccination 4) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 |
| Extension Stage (Vaccination 4) | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Extension Stage (Vaccination 4) | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 2 | 1 | 2 | 1 |
| Extension Stage (Vaccination 4) | No Longer Willing To Participate In Study | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 1 |
| Extension Stage (Vaccination 4) | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 1 | 0 |
| Extension Stage (Vaccination 4) | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 2 | 1 | 0 | 1 |
| Extension Stage (Vaccination 4) | Withdrew consent | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 1 | 2 | 2 | 3 | 0 |
| Vaccination 1 to 3 | Adverse Event | 4 | 5 | 0 | 3 | 4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination 1 to 3 | Death | 2 | 1 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination 1 to 3 | Lost to Follow-up | 3 | 4 | 0 | 2 | 3 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination 1 to 3 | No longer meets eligibility criteria | 0 | 1 | 0 | 4 | 4 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination 1 to 3 | No longer willing to participate | 2 | 4 | 0 | 4 | 1 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination 1 to 3 | Other | 7 | 3 | 1 | 7 | 5 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination 1 to 3 | Protocol Violation | 1 | 0 | 1 | 2 | 5 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination 1 to 3 | Randomized but not treated | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Vaccination 1 to 3 | Withdrawal by Subject | 3 | 4 | 4 | 2 | 6 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Placebo: Day 1, 8 and 30 Regimen | Clostridium Difficile Vaccine(100 mcg):Month0, 1and 6 Regimen | Clostridium Difficile Vaccine(200 mcg):Month0, 1and 6 Regimen | Placebo: Month 0, 1 and 6 Regimen |
|---|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 854 Participants | 182 Participants | 184 Participants | 61 Participants | 183 Participants | 183 Participants | 61 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Ethnicity: Hispanic | 139 Participants | 55 Participants | 41 Participants | 13 Participants | 15 Participants | 11 Participants | 4 Participants |
| Race/Ethnicity, Customized Ethnicity: Non-Hispanic | 715 Participants | 127 Participants | 143 Participants | 48 Participants | 168 Participants | 172 Participants | 57 Participants |
| Race/Ethnicity, Customized Race: Asian | 26 Participants | 2 Participants | 0 Participants | 0 Participants | 13 Participants | 10 Participants | 1 Participants |
| Race/Ethnicity, Customized Race: Black | 56 Participants | 6 Participants | 16 Participants | 2 Participants | 16 Participants | 13 Participants | 3 Participants |
| Race/Ethnicity, Customized Race: Other | 9 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants | 1 Participants |
| Race/Ethnicity, Customized Race: White | 763 Participants | 172 Participants | 168 Participants | 59 Participants | 151 Participants | 157 Participants | 56 Participants |
| Sex: Female, Male Female | 461 Participants | 93 Participants | 106 Participants | 35 Participants | 93 Participants | 97 Participants | 37 Participants |
| Sex: Female, Male Male | 393 Participants | 89 Participants | 78 Participants | 26 Participants | 90 Participants | 86 Participants | 24 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 | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 182 | 1 / 184 | 0 / 61 | 2 / 183 | 0 / 183 | 0 / 61 | 0 / 16 | 0 / 18 | 0 / 24 | 1 / 22 | 0 / 51 | 0 / 52 | 0 / 58 | 0 / 59 |
| other Total, other adverse events | 128 / 182 | 144 / 184 | 38 / 61 | 158 / 183 | 156 / 183 | 52 / 61 | 9 / 16 | 7 / 18 | 11 / 24 | 14 / 22 | 22 / 51 | 20 / 52 | 31 / 58 | 34 / 59 |
| serious Total, serious adverse events | 11 / 182 | 6 / 184 | 0 / 61 | 19 / 183 | 22 / 183 | 2 / 61 | 6 / 16 | 3 / 18 | 3 / 24 | 2 / 22 | 4 / 51 | 2 / 52 | 6 / 58 | 5 / 59 |
Outcome results
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 37
Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay.
Time frame: Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 37 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 37 | 26.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 37 | 38.8 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37
Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay.
Time frame: Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37 | 12.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37 | 68.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 37 | 85.5 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 37
Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay.
Time frame: Day 37 (7 days after Vaccination 3 of Day 1, 8 and 30 regimen)
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 37 | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 37 | 29.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 37 | 38.8 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis).
Time frame: within 14 days After Vaccination 2
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Any | 1.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Mild | 1.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Severe | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Any | 31.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Moderate | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Mild | 25.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Mild | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Mild | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Moderate | 6.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Severe | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Moderate | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Any | 3.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Any | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Any | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Moderate | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Mild | 2.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Moderate | 4.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Moderate | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Severe | 2.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Any | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Any | 41.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Mild | 36.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Mild | 3.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Grade 4 | 0.0 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis).
Time frame: within 14 days after Vaccination 3
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Any | 3.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Mild | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Mild | 18.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Mild | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Any | 22.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Moderate | 4.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Any | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Moderate | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Any | 2.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Mild | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Moderate | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Moderate | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Mild | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Any | 5.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Moderate | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Mild | 2.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Any | 5.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Mild | 21.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Moderate | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Any | 22.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Severe | 0.0 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2)(interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 centimeter \[cm\]), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis).
Time frame: within 7 days After Vaccination 1
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Mild | 6.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Any | 6.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Any | 19.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Mild | 17.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Moderate | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Any | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Mild | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Moderate | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Mild | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Mild | 14.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Mild | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Any | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Any | 15.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Moderate | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Moderate | 1.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Redness: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 7 Days After Vaccination 1 | Swelling: Any | 1.6 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2
Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).
Time frame: within 14 days after Vaccination 2
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Mild | 3.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Mild | 6.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Any | 20.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Any | 10.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Moderate | 3.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Any | 8.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Any | 5.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Any | 3.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Moderate | 10.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Mild | 3.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Mild | 6.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Severe | 3.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Mild | 1.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Mild | 6.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Moderate | 5.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Moderate | 8.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Any | 15.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Moderate | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Moderate | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Moderate | 2.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Any | 12.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Mild | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Moderate | 3.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Any | 17.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Moderate | 7.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Any | 10.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Mild | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Any | 6.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Any | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Any | 9.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Mild | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Mild | 10.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Moderate | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Mild | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Mild | 8.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Mild | 7.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Moderate | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Moderate | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Moderate | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Mild | 8.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Any | 13.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Any | 13.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Any | 7.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Mild | 10.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Moderate | 7.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Any | 19.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Mild | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Any | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Moderate | 3.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Mild | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Any | 12.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Severe | 0.6 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3
Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).
Time frame: within 14 days after Vaccination 3
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Any | 14.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Moderate | 7.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Mild | 8.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Mild | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Mild | 10.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Moderate | 3.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Any | 17.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Severe | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Moderate | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Any | 10.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Any | 5.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Mild | 8.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Any | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Mild | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Mild | 3.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Any | 3.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Moderate | 3.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Any | 5.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Moderate | 5.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Any | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Mild | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Any | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Mild | 2.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Any | 8.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Mild | 4.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Moderate | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Any | 9.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Mild | 4.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Moderate | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Mild | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Moderate | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Any | 4.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Mild | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Moderate | 2.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Moderate | 5.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Mild | 4.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Mild | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Any | 8.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Any | 12.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Mild | 4.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Mild | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Moderate | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Moderate | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Any | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Any | 11.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Any | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Mild | 4.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Moderate | 7.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Moderate | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Any | 5.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Mild | 7.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Moderate | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Mild | 5.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Any | 8.2 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1
Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 degree Celsius (C)), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).
Time frame: within 7 days after Vaccination 1
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Any | 3.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Mild | 11.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Moderate | 3.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Any | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Mild | 11.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Any | 11.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Moderate | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Any | 14.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Mild | 8.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Moderate | 3.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Any | 13.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Moderate | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Mild | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Mild | 1.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Any | 2.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Any | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Any | 7.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Mild | 7.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Mild | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Any | 7.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Mild | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Moderate | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Any | 10.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Mild | 7.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Moderate | 2.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Any | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Mild | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Moderate | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Mild | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Moderate | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Severe | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Severe | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Any | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Mild | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Any | 8.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Mild | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Mild | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Moderate | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Moderate | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Mild | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Any | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Moderate | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Mild | 7.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Mild | 7.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Headache: Any | 11.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Any | 18.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | New or worsening joint pain: Any | 8.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Any | 9.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Mild | 9.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Fatigue: Moderate | 8.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 7 Days After Vaccination 1 | Diarrhea: Moderate | 1.6 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From Vaccination 1 up to 28 days after Vaccination 3 (Day 58)
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs) | 27.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs) | 23.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs) | 36.4 percentage of participants |
Primary
Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events between first dose of study drug and up to 6 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From Vaccination 1 up to 6 months after Vaccination 3 (Month 7)
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 6.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 3.3 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Month 7
Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay.
Time frame: Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Month 7 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Month 7 | 74.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Month 7 | 86.1 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Month 7
Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay.
Time frame: Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Month 7 | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Month 7 | 98.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Month 7 | 95.6 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Month 7
Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay.
Time frame: Month 7 (1 month after Vaccination 3 of Month 0, 1 and 6 regimen)
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Month 7 | 7.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Month 7 | 74.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Month 7 | 87.3 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis).
Time frame: within 14 days After Vaccination 1
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Moderate | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Mild | 6.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Any | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Any | 8.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Mild | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Any | 24.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Mild | 22.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Moderate | 2.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Moderate | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Any | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Mild | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Moderate | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Any | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Moderate | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Mild | 19.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Moderate | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Any | 19.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Severe | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Severe | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Pain: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Mild | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Any | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Severe | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Redness: Any | 2.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 1 | Swelling: Mild | 0.0 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis).
Time frame: within 14 days after Vaccination 2
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Any | 5.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Mild | 5.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Moderate | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Any | 27.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Mild | 23.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Any | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Mild | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Any | 4.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Mild | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Moderate | 4.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Moderate | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Severe | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Any | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Moderate | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Mild | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Mild | 25.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Any | 27.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Severe | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Severe | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Redness: Mild | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Pain: Moderate | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 2 | Swelling: Any | 4.0 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (did not interfere with activity), moderate (interfered with activity), severe (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis).
Time frame: within 14 days after Vaccination 3
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Any | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Moderate | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Any | 22.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Any | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Mild | 3.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Moderate | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Any | 2.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Mild | 2.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Moderate | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Mild | 19.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Any | 26.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Moderate | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Mild | 3.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Any | 4.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Moderate | 4.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Any | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Pain: Mild | 21.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Swelling: Mild | 4.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 3 | Redness: Moderate | 0.6 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1
Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).
Time frame: within 14 days after Vaccination 1
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Any | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Severe | 3.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Any | 9.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Mild | 3.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Severe | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Moderate | 6.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Any | 9.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Mild | 3.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Moderate | 4.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Severe | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Any | 21.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Mild | 14.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 4.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Severe | 1.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Any | 27.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Mild | 19.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Moderate | 8.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Any | 31.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Mild | 14.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Moderate | 13.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Mild | 14.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Moderate | 5.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Severe | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Mild | 17.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Moderate | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Any | 1.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Any | 14.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 2.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Any | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Mild | 8.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Any | 28.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Moderate | 5.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Severe | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Mild | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Any | 9.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Any | 15.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Mild | 5.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Moderate | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Moderate | 13.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Mild | 10.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Mild | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Any | 19.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Mild | 8.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Severe | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Any | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Mild | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Any | 19.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Mild | 13.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Moderate | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Severe | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Any | 16.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Mild | 9.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Moderate | 6.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Any | 26.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Mild | 12.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Moderate | 13.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Severe | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Any | 14.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Mild | 6.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Moderate | 7.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Severe | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Any | 16.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Moderate | 7.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | New or worsening joint pain: Severe | 0.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 1 | Fever: Moderate | 0.0 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2
Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).
Time frame: within 14 days after Vaccination 2
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Moderate | 10.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Any | 5.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Mild | 8.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Any | 18.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Any | 8.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Mild | 5.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Severe | 1.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Any | 18.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Mild | 10.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Moderate | 8.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Moderate | 3.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Moderate | 3.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Any | 1.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Any | 20.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Mild | 10.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Moderate | 10.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Mild | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Any | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Moderate | 4.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Any | 14.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Mild | 9.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Moderate | 11.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Any | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Any | 11.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Mild | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Moderate | 5.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Mild | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Mild | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Any | 20.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Mild | 15.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Moderate | 5.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Any | 23.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Mild | 11.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Any | 8.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Mild | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Moderate | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Mild | 5.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Any | 18.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Moderate | 11.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Mild | 6.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fatigue: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Moderate | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Mild | 5.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Moderate | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Moderate | 4.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Moderate | 5.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Mild | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Moderate | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Fever: Any | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Mild | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening muscle pain: Any | 10.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Any | 14.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Any | 10.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Mild | 10.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Any | 15.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Headache: Mild | 9.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | Vomiting: Any | 1.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 2 | New or worsening joint pain: Severe | 0.0 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3
Systemic events included fever, vomiting, diarrhea, headache, fatigue, new or worsening muscle pain, new or worsening joint pain and were recorded by using an e-diary. Fever was graded as mild (38.0 to 38.4 C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration) and grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and grade 4 (hospitalization). Headache, fatigue, new or worsening muscle pain and new or worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and grade 4 (hospitalization).
Time frame: within 14 days after Vaccination 3
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here N signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Moderate | 5.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Severe | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Mild | 5.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Moderate | 11.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Moderate | 5.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Mild | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Mild | 5.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Any | 14.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Mild | 13.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Any | 18.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Any | 11.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Moderate | 5.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Moderate | 9.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Mild | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Any | 11.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Any | 11.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Moderate | 3.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Any | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Mild | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Any | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Mild | 11.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Moderate | 4.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Any | 12.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Severe | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Mild | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Any | 20.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Mild | 14.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Moderate | 4.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Severe | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Any | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Mild | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Moderate | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Any | 7.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Mild | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Moderate | 4.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Severe | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Mild | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Any | 10.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Mild | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Mild | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Mild | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Moderate | 6.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Moderate | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Vomiting: Any | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Moderate | 3.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Any | 14.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Any | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Mild | 7.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Any | 16.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Moderate | 3.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Mild | 9.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Mild | 9.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | New or worsening joint pain: Any | 8.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Fatigue: Moderate | 6.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 3 | Diarrhea: Any | 12.4 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From Vaccination 1 up to 28 days after Vaccination 3 (Day 208)
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs) | 54.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs) | 53.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Adverse Events (AEs) | 55.7 percentage of participants |
Primary
Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events between first dose of study drug and up to 6 months after last dose of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From Vaccination 1 up to 6 months after Vaccination 3 (Month 12)
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 3.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 10.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 12.0 percentage of participants |
Secondary
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13
Geometric mean concentration (GMC) of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. Confidence interval (CI) for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.
Time frame: Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 89 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 89 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 95 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 102 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 1 | 86 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 81 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 81 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 88 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 85 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 368 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 1 | 83 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 98 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 143 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 168 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 295 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 153 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 118 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 105 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 192 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 1 | 85 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 238 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 104 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 138 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 556 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 230 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 166 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 484 neutralization units/mL |
Secondary
Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13
GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.
Time frame: Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 190 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 1 | 193 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 180 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 211 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 178 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 181 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 190 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 179 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 188 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 705 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 1 | 187 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 273 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 807 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 728 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 676 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 513 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 475 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 447 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 1125 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 1 | 188 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 1029 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 836 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 1091 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 828 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 1219 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 290 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 755 neutralization units/mL |
Secondary
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13
Geometric mean fold rise (GMFR) in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Time frame: Day 8, 15, 30, 37 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 1.03 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 0.95 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 1.04 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 1.20 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 1.11 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 0.99 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 0.95 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 1.03 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 2.03 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 1.43 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 4.45 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 3.56 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 1.85 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 1.19 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 1.73 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 1.26 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 2.72 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 2.27 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 1.22 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 6.56 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 1.95 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 2.81 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 5.71 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 1.64 fold rise |
Secondary
Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13
GMFR in toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Time frame: Day 8, 15, 30, 37 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. Here, N= number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 1.10 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 0.93 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 0.95 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 0.98 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 0.97 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 0.96 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 0.99 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 0.93 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 1.46 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 2.52 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 2.40 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 3.76 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 2.73 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 3.89 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 3.61 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 4.31 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13 | 4.44 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15 | 5.86 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30 | 5.53 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37 | 6.57 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2 | 6.06 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4 | 4.55 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7 | 4.05 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8 | 1.55 fold rise |
Secondary
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13
Toxin A and toxin B antibodies were measured using neutralization assay.
Time frame: Day 8, 15, 30, 37 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=16 fold rise | 2.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=4 fold rise | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=8 fold rise | 14.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=8 fold rise | 11.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=8 fold rise | 2.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=32 fold rise | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=16 fold rise | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=32 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=32 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=16 fold rise | 2.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=16 fold rise | 6.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=4 fold rise | 12.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=4 fold rise | 5.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=32 fold rise | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=8 fold rise | 7.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=4 fold rise | 25.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=4 fold rise | 7.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=16 fold rise | 4.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=8 fold rise | 2.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=4 fold rise | 8.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=32 fold rise | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=16 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=4 fold rise | 21.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=4 fold rise | 13.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=8 fold rise | 4.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=8 fold rise | 3.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=8 fold rise | 7.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=32 fold rise | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=16 fold rise | 4.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=32 fold rise | 4.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=32 fold rise | 5.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=16 fold rise | 3.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=4 fold rise | 36.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=8 fold rise | 25.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=16 fold rise | 11.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=4 fold rise | 34.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=8 fold rise | 21.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=4 fold rise | 14.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=16 fold rise | 10.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=32 fold rise | 5.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=4 fold rise | 19.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=8 fold rise | 6.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=8 fold rise | 9.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=4 fold rise | 3.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=16 fold rise | 3.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=8 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=16 fold rise | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=32 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=32 fold rise | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=4 fold rise | 17.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=16 fold rise | 1.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=8 fold rise | 14.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=16 fold rise | 9.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=4 fold rise | 13.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=16 fold rise | 11.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=32 fold rise | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=4 fold rise | 20.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=8 fold rise | 14.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=8 fold rise | 7.0 percentage of participants |
Secondary
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13
Toxin A antibodies were measured using neutralization assay.
Time frame: Day 8, 15, 30, 37 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=4 fold rise | 5.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=4 fold rise | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=4 fold rise | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=8 fold rise | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=32 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=32 fold rise | 5.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=4 fold rise | 46.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=8 fold rise | 25.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=32 fold rise | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=16 fold rise | 8.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=4 fold rise | 32.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=8 fold rise | 18.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=16 fold rise | 5.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=32 fold rise | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=4 fold rise | 13.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=16 fold rise | 4.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=8 fold rise | 7.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=32 fold rise | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=8 fold rise | 5.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=4 fold rise | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=8 fold rise | 2.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=16 fold rise | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=16 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=32 fold rise | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=4 fold rise | 9.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=4 fold rise | 14.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=8 fold rise | 9.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=16 fold rise | 5.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=32 fold rise | 4.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=16 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=4 fold rise | 17.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=8 fold rise | 8.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=4 fold rise | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=16 fold rise | 5.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=16 fold rise | 3.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=8 fold rise | 17.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=4 fold rise | 4.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=32 fold rise | 8.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=32 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=8 fold rise | 10.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=4 fold rise | 65.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=8 fold rise | 9.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=8 fold rise | 4.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=8 fold rise | 40.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=4 fold rise | 16.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=8 fold rise | 17.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=16 fold rise | 14.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=32 fold rise | 8.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=16 fold rise | 3.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=4 fold rise | 59.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=16 fold rise | 14.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=8 fold rise | 31.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=16 fold rise | 5.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=16 fold rise | 12.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=8 fold rise | 12.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=32 fold rise | 2.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=32 fold rise | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=32 fold rise | 1.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=4 fold rise | 25.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=4 fold rise | 24.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=32 fold rise | 9.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=4 fold rise | 19.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=16 fold rise | 5.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=16 fold rise | 13.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=4 fold rise | 16.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=32 fold rise | 2.5 percentage of participants |
Secondary
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13
Toxin B antibodies were measured using neutralization assay.
Time frame: Day 8, 15, 30, 37 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=32 fold rise | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=8 fold rise | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=16 fold rise | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=4 fold rise | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=4 fold rise | 34.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=8 fold rise | 19.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=16 fold rise | 8.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=8 fold rise | 33.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=8 fold rise | 17.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=32 fold rise | 1.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=32 fold rise | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=16 fold rise | 4.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=16 fold rise | 22.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=8 fold rise | 33.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=32 fold rise | 14.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=16 fold rise | 14.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=32 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=32 fold rise | 17.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=4 fold rise | 35.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=16 fold rise | 10.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=4 fold rise | 41.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=4 fold rise | 36.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=8 fold rise | 33.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=16 fold rise | 24.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=8 fold rise | 8.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=32 fold rise | 16.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=16 fold rise | 26.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=4 fold rise | 39.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=4 fold rise | 11.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=8 fold rise | 32.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=16 fold rise | 22.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=32 fold rise | 20.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=4 fold rise | 35.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=8 fold rise | 23.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=32 fold rise | 5.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=4 fold rise | 39.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=16 fold rise | 20.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=4 fold rise | 14.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=8 fold rise | 8.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=32 fold rise | 3.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=8 fold rise | 38.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=16 fold rise | 35.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=32 fold rise | 29.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=4 fold rise | 42.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=8 fold rise | 39.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=16 fold rise | 37.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 30: >=32 fold rise | 27.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=4 fold rise | 46.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=8 fold rise | 40.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=16 fold rise | 37.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 37: >=32 fold rise | 27.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=4 fold rise | 46.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=8 fold rise | 38.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=16 fold rise | 34.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=4 fold rise | 42.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=16 fold rise | 25.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=32 fold rise | 16.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=4 fold rise | 45.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=8 fold rise | 30.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=16 fold rise | 20.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=32 fold rise | 14.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 8: >=16 fold rise | 4.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Day 15: >=4 fold rise | 41.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 2: >=32 fold rise | 24.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 4: >=8 fold rise | 34.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 7: >=32 fold rise | 13.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=4 fold rise | 46.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 8, 15, 30, 37 and Month 2, 4, 7, 13 | Month 13: >=8 fold rise | 30.5 percentage of participants |
Secondary
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13
Toxin A and toxin B antibodies were measured using neutralization assay.
Time frame: Day 1, 8, 15, 30 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 7 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 13 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 30 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 15 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 1 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 8 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 2 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 2 | 24.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 4 | 13.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 1 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 15 | 11.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 7 | 8.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 8 | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 13 | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 30 | 15.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 13 | 15.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 7 | 15.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 1 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 8 | 4.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 15 | 18.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 30 | 20.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 2 | 36.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 4 | 24.4 percentage of participants |
Secondary
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13
Toxin A antibodies were measured using neutralization assay.
Time frame: Day 1, 8, 15, 30 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 1 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 8 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 15 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 30 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 2 | 3.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 4 | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 7 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 13 | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 15 | 17.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 7 | 15.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 30 | 26.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 2 | 61.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 4 | 29.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 1 | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 8 | 4.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 13 | 10.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 15 | 25.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 8 | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 1 | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Day 30 | 36.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 7 | 31.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 4 | 52.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 2 | 85.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 8, 15, 30, and Month 2, 4, 7, 13 | Month 13 | 25.8 percentage of participants |
Secondary
Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13
Toxin B antibodies were measured using neutralization assay.
Time frame: Day 1, 8, 15, 30 and Month 2, 4, 7, 13
Population: Evaluable immunogenicity population: All eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 3 and had no major protocol violations. N= number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 8 | 3.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 7 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 13 | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 1 | 5.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 15 | 3.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 2 | 1.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 30 | 3.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 2 | 29.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 15 | 30.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 30 | 29.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 7 | 24.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 8 | 9.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 1 | 4.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 13 | 19.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 4 | 26.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 13 | 31.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 1 | 3.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 8 | 11.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 30 | 37.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 2 | 37.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 4 | 31.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Month 7 | 26.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Day 1, 8, 15, 30 and Month 2, 4, 7, 13 | Day 15 | 37.2 percentage of participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
GMC of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.
Time frame: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 87 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 95 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 89 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 89 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 87 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 85 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 88 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 88 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 96 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 468 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 142 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 2161 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 5446 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 1745 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 908 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 666 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 447 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 495 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 96 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 95 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 96 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 120 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 102 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 126 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 92 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 109 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 118 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 2686 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 1417 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 774 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 925 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 198 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 659 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 8013 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 656 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 3787 neutralization units per milliliter |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.
Time frame: Extension Stage Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 239 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 267 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 211 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 322 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 256 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 216 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 221 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 298 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 289 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 6707 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 3530 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 5428 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 14754 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 25297 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 3373 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 12467 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 1352 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 3457 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 807 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 791 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 939 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 876 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 787 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 941 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 932 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 709 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 689 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 7101 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 19239 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 50637 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 7115 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 6061 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 1632 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 8340 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 11126 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 18832 neutralization units per milliliter |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36
GMFR in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 1.00 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 1.08 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 1.01 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 1.00 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 1.09 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 0.97 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.97 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.99 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 3.05 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 4.54 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 38.41 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 3.74 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 3.19 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 6.40 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 12.31 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 15.25 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.85 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 0.95 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 0.90 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 0.94 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 0.88 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.89 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 0.98 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 1.04 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 13.57 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 7.16 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 40.47 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 19.13 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 4.67 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 3.91 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 3.32 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 3.29 fold rise |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36
GMFR in toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 0.96 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 1.09 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 1.21 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 1.12 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 0.81 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 0.79 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.74 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.87 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 2.27 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 3.49 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 18.70 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 2.40 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 2.17 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 4.96 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 9.22 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 10.91 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.77 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 1.09 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 0.93 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 1.02 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 1.01 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.74 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 1.02 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 1.19 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 11.79 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 6.82 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 31.02 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 11.54 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 5.11 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 3.68 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 3.13 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 3.80 fold rise |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent adverse events are events from dose 4 of study drug to 28 days after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From Vaccination 4 up to 28 days after Vaccination 4
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | 1 Participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | 0 Participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | 4 Participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | 3 Participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events from dose 4 of study drug to 6 months after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From Vaccination 4 up to 6 months after Vaccination 4
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 0 Participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 0 Participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 1 Participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 1 Participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin A and B antibodies were measured using neutralization assay.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 83.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 72.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 55.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 38.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 44.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 27.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 47.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 29.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 11.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 5.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 72.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 50.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 11.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 11.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 33.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 40.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 33.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 40.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 5.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 11.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 10.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 40.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 45.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 38.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 35.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 10.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 85.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 15.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 65.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 15.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 10.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 55.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 36.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 35.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 25.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 27.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 10.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 70.0 percentage of participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin A antibodies were measured using neutralization assay.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 11.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 25.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 88.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 66.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 38.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 33.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 100.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 88.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 72.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 50.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 72.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 61.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 44.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 72.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 50.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 27.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 47.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 41.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 11.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 41.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 23.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 29.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 17.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 11.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 50.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 4.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 85.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 70.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 5.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 5.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 30.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 55.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 75.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 25.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 45.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 38.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 5.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 70.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 15.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 85.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 11.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 5.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 55.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 16.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 65.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 47.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 90.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 16.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 80.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 31.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 40.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 38.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 75.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 15.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 35.0 percentage of participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin B antibodies were measured using neutralization assay.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 12.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 35.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 55.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 33.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 33.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 83.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 83.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 55.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 38.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 66.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 50.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 38.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 22.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 55.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 44.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 47.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 17.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 11.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 77.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 17.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 5.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 35.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 5.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 31.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 5.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 10.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 45.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 38.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 20.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 65.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 25.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 60.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 55.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 27.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 15.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 11.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 20.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 5.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 47.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 80.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 5.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 26.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 35.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 45.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 50.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 15.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 90.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 25.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 70.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 5.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 75.0 percentage of participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay.
Time frame: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 83.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 52.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 70.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 88.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 11.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 100.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 68.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 58.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 94.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 9.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 8.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 10.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 10.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 10.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 73.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 85.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 95.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 77.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 72.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 95.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 75.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 80.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 15.0 percentage of participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay.
Time frame: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 12.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 7.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 7.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 88.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 82.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 82.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 100.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 22.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 100.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 87.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 76.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 100.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 14.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 20.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 12.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 29.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 21.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 15.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 10.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 10.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 84.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 100.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 100.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 94.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 94.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 100.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 95.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 95.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 30.0 percentage of participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay.
Time frame: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 12.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 12.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 12.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 88.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 64.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 82.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 88.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 44.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 100.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 75.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 70.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 94.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 19.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 29.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 25.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 25.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 21.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 30.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 25.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 25.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 25.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 78.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 85.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 95.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 77.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 77.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 95.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 75.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 85.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 40.0 percentage of participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2) (interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). Any local reaction referred to any injection site pain, any swelling, or any redness.
Time frame: Within 14 days after Vaccination 4
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Any | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Mild | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Any | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Moderate | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Any | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Any | 13.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Any | 13.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Mild | 9.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Mild | 13.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Moderate | 4.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Mild | 27.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Moderate | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Moderate | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Any | 27.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Grade 4 | 0.0 percentage of participants |
Secondary
Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4
Systemic events included following events: Fever was graded as mild (38.0 to 38.4 degree C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade (G) 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration)/grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and G4 (hospitalization). Headache, fatigue, new/worsening muscle pain and new/worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and G4 (hospitalization). Any systemic event referred to any fever \>= 38.0 degree C, any vomiting, any diarrhea, any headache, any fatigue, any new/worsening muscle pain, or any new or worsening joint pain.
Time frame: Within 14 days after Vaccination 4
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Mild | 18.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Any | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Any | 37.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Moderate | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Mild | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Any | 12.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Mild | 12.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Any | 12.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Any | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Mild | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Moderate | 6.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Moderate | 18.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Any | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Any | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Any | 27.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Mild | 11.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Mild | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Moderate | 11.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Any | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Mild | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Mild | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Moderate | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Any | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Mild | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Any | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Moderate | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Any | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Moderate | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Any | 25.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Mild | 12.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Moderate | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Severe | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Mild | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Any | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Moderate | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Any | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Mild | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Severe | 4.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Mild | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Mild | 18.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Mild | 9.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Moderate | 4.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Any | 9.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Moderate | 4.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Mild | 9.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Any | 13.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Any | 4.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Moderate | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Moderate | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Mild | 4.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Mild | 4.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Moderate | 4.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Any | 4.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Mild | 13.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Any | 18.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Any | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Moderate | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Any | 22.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Day 1, 8 and 30 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Moderate | 0.0 percentage of participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
GMC of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.
Time frame: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 200 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 130 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 163 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 230 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 172 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 129 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 120 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 235 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 173 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 1188 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 273 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 222 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 152 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 3288 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 1107 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 649 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 348 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 298 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 146 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 211 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 141 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 271 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 193 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 139 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 227 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 249 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 283 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 355 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 281 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 2300 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 4695 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 1538 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 982 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 438 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 386 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin A Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 497 neutralization units per milliliter |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.
Time frame: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 1613 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 875 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 885 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 1258 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 1328 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 1347 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 911 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 1207 neutralization units per milliliter |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 1424 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 2693 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 1464 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 1587 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 5011 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 704 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 11885 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 1165 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 1400 neutralization units per milliliter |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 4306 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 1681 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 1925 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 1862 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 1776 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 2056 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 997 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 1436 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 1227 neutralization units per milliliter |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 1021 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 3299 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 10842 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 32905 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 2408 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 3027 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 17205 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 3079 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 7126 neutralization units per milliliter |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Concentration for Toxin B Specific Neutralizing Antibody Levels at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 2186 neutralization units per milliliter |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36
GMFR in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 1.02 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 0.87 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 0.74 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 0.71 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 0.57 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 0.76 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.51 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.55 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 1.89 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 2.24 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 21.57 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 1.45 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 1.76 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 4.15 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 7.07 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 7.80 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.56 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 0.89 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 0.85 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 0.55 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 0.75 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.53 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 1.09 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 1.14 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 5.47 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 3.41 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 16.68 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 8.17 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 1.73 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 1.22 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 1.34 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 1.55 fold rise |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36
GMFR in toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 0.95 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 0.93 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 0.86 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 0.81 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 0.58 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 1.07 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.58 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.56 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 2.00 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 2.25 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 16.88 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 1.85 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 2.09 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 3.73 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 5.97 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 7.12 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 0.60 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 1.08 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 0.89 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 0.51 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 0.70 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 0.47 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 0.97 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 0.92 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 4.96 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 3.10 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 15.05 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 7.87 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 1.34 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 1.09 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 1.36 fold rise |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 1.45 fold rise |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Treatment-emergent adverse events are events from dose 4 of study drug to 28 days after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From Vaccination 4 up to 28 days after Vaccination 4
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | 10 Participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | 8 Participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | 17 Participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Adverse Events (AEs) | 16 Participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; lack of efficacy in an approved indication. Treatment-emergent serious adverse events are events from dose 4 of study drug to 6 months after dose 4 of study drug that were absent before treatment or that worsened relative to pretreatment state.
Time frame: From Vaccination 4 up to 6 months after Vaccination 4
Population: Safety population: all participants who received at least 1 dose of the investigational product.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 2 Participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 1 Participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 1 Participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin A and B antibodies were measured using neutralization assay.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 2.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 4.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 4.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 44.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 19.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 54.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 4.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 38.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 59.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 34.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 9.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 78.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 61.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 26.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 14.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 14.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 4.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 18.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 8.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 2.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 15.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 2.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 13.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 18.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 71.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 5.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 3.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 1.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 20.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 13.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 3.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 6.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 40.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 5.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 59.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 18.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 55.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 39.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 7.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 1.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 39.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Both Toxin A and Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin A antibodies were measured using neutralization assay.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 2.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 2.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 4.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 4.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 28.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 78.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 4.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 34.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 26.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 2.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 94.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 13.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 26.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 18.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 13.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 29.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 70.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 23.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 14.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 75.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 10.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 44.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 67.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 52.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 50.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 2.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 2.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 9.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 5.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 1.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 7.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 72.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 39.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 15.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 18.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 32.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 5.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 24.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 24.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 1.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 36.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 55.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 1.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 61.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 32.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 71.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 17.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 1.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 8.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 3.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 55.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 84.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 7.3 percentage of participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin B antibodies were measured using neutralization assay.
Time frame: Days 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 6.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 4.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 9.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 6.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 2.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 2.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 2.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 2.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 4.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 7.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 2.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 13.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 20.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 4.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 9.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 12.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 65.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 48.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 26.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 80.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 65.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 51.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 34.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 64.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 4.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 32.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 20.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 4.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 2.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 13.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 38.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 22.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 46.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 30.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 14.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 31.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 31.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 15.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 36.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 13.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 6.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 4.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 3.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 2.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 7.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 2.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 5.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 3.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 2.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 2.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 1.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 5.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 1.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=4 fold rise | 81.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=4 fold rise | 69.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=8 fold rise | 35.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=32 fold rise | 11.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=4 fold rise | 18.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=16 fold rise | 1.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=16 fold rise | 11.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=32 fold rise | 30.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=16 fold rise | 1.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=16 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=8 fold rise | 7.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=4 fold rise | 32.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=16 fold rise | 50.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=4 fold rise | 13.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=16 fold rise | 37.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=8 fold rise | 12.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8: >=8 fold rise | 54.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=32 fold rise | 3.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=16 fold rise | 5.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12: >=32 fold rise | 1.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30: >=8 fold rise | 64.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=32 fold rise | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=16 fold rise | 3.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=4 fold rise | 12.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30: >=32 fold rise | 1.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=8 fold rise | 5.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18: >=4 fold rise | 12.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=8 fold rise | 5.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36: >=8 fold rise | 1.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6: >=4 fold rise | 57.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Days 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24: >=32 fold rise | 0.0 percentage of participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin A and B antibodies (threshold \>= 219 and 2586 neutralization units/mL) were measured using neutralization assay.
Time frame: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 22.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 9.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 9.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 19.1 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 25.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 25.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 12.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 17.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 29.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 62.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 29.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 40.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 69.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 9.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 86.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 18.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 22.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 70.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 25.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 27.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 25.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 29.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 29.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 14.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 26.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 15.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 8.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 50.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 84.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 96.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 45.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 47.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 89.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 53.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 81.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 40.7 percentage of participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin A antibodies (threshold \>= 219 neutralization units/mL) were measured using neutralization assay.
Time frame: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 34.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 22.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 19.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 37.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 20.5 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 54.2 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 38.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 40.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 50.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 98.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 73.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 88.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 32.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 45.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 60.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 94.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 100.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 68.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 47.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 37.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 50.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 53.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 56.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 47.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 25.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 29.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 24.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 91.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 100.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 94.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 61.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 71.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 72.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 96.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 96.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 77.2 percentage of participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36
Toxin B antibodies (threshold \>= 2586 neutralization units/mL) were measured using neutralization assay.
Time frame: Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 after Vaccination 4
Population: Evaluable immunogenicity population: All eligible participants re-randomized to the extension stage of study, who received fourth study vaccination with formulation to which they were randomized, had at least 1 valid assay result from blood drawn within 7 to 14 days after Vaccination 4 and had no major protocol violations. Here, 'Number Analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 50.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 27.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 29.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 31.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 35.4 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 33.3 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 31.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 32.6 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 39.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 62.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 31.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 42.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 69.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 15.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 86.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 27.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 31.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 70.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 43.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 41.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 36.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 43.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 47.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 35.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 35.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 29.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 26.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 24 | 52.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 6 | 86.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 30 | 96.6 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 36 | 52.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 30 | 58.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 8 | 91.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 18 | 55.2 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Month 12 | 82.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin B at Days 1, 8, 30 and Months 6, 12, 18, 24, 30, 36 | Day 1 | 50.8 percentage of participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4
Local reactions included pain at injection site, swelling and redness collected by using an electronic diary (e-diary). Pain was graded as: mild (grade 1) (did not interfere with activity), moderate (grade 2) (interfered with activity), severe (grade 3) (prevented daily activity) and grade 4 (emergency room visit or hospitalization). Redness and swelling were graded as: mild (2.5-5.0 cm), moderate (\>5.0 to 10.0 cm), severe (\>10.0 cm) and grade 4 (necrosis). Any local reaction referred to any injection site pain, any swelling, or any redness.
Time frame: Within 14 days after Vaccination 4
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Mild | 6.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Any | 6.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Any | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Moderate | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Any | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Mild | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Mild | 21.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Mild | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Any | 23.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Any | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Mild | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Mild | 1.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Mild | 16.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Mild | 3.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Any | 3.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Any | 20.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Moderate | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Pain: Moderate | 3.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Swelling: Any | 3.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Local Reactions by Severity Within 14 Days After Vaccination 4 | Redness: Moderate | 1.7 percentage of participants |
Secondary
Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4
Systemic events included following events: Fever was graded as mild (38.0 to 38.4 degree C), moderate (38.5 to 38.9 degree C), severe (39.0 to 40.0 degree C), grade (G) 4 (\>40.0 degree C). Vomiting was graded as mild (1-2 times in 24 hours), moderate (\>2 times in 24 hours), severe (required intravenous hydration)/grade 4 (hospitalization for hypotensive shock). Diarrhea was graded as mild (2-3 loose stools in 24 hours), moderate (4-5 loose stools in 24 hours), severe (\>=6 stools in 24 hours) and G4 (hospitalization). Headache, fatigue, new/worsening muscle pain and new/worsening joint pain was graded as mild (no interference with activity), moderate (some interference with activity), severe (prevents daily activity) and G4 (hospitalization). Any systemic event referred to any fever \>= 38.0 degree C, any vomiting, any diarrhea, any headache, any fatigue, any new/worsening muscle pain, or any new or worsening joint pain.
Time frame: within 14 days after Vaccination 4
Population: Safety population: all participants who received at least 1 dose of the investigational product. Here Overall Number of Participants Analyzed signifies number of participants evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Moderate | 6.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Mild | 12.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Any | 12.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Any | 18.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Mild | 8.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Moderate | 4.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Mild | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Moderate | 2.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Any | 16.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Moderate | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Moderate | 4.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Mild | 14.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Any | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Mild | 4.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Mild | 4.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Moderate | 2.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Any | 6.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Any | 8.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Severe | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Mild | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Moderate | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Any | 13.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Mild | 9.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Moderate | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Any | 9.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Mild | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Moderate | 5.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Any | 15.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Mild | 5.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Moderate | 9.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Any | 7.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Mild | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Any | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Moderate | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Any | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Mild | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Any | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Any | 17.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Any | 13.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Mild | 10.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Moderate | 6.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Any | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Mild | 10.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Moderate | 5.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Mild | 5.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Any | 12.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Mild | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Mild | 8.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Moderate | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Mild | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Mild | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Grade 4 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Severe | 3.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Any | 10.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Moderate | 5.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Any | 24.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Moderate | 10.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Moderate | 8.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Severe | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Any | 3.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Mild | 11.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Moderate | 8.5 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Moderate | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Moderate | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Moderate | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Any | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Any | 6.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Mild | 11.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Mild | 1.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Any | 6.8 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Mild | 1.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Any | 11.9 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Mild | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Moderate | 5.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening joint pain: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Any | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Moderate | 1.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Mild | 1.7 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Vomiting: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Severe | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | New or worsening muscle pain: Moderate | 5.1 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Any | 3.4 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Headache: Grade 4 | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fever: Mild | 0.0 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Fatigue: Any | 20.3 percentage of participants |
| 200mcg Clostridium Difficile Vaccine to 200mcg Clostridium Difficile Vaccine:Day 1, 8 and 30 Regimen | Extension Stage Month 0, 1 and 6 Regimen: Percentage of Participants With Systemic Events by Severity Within 14 Days After Vaccination 4 | Diarrhea: Grade 4 | 0.0 percentage of participants |
Secondary
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18
GMC of toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.
Time frame: Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 89 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 82 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 90 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 89 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 93 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 1 | 83 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 83 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 84 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 80 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 214 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 500 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 231 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 1 | 85 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 1245 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 137 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 115 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 378 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 214 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 257 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 1 | 87 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 149 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 329 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 301 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 136 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 744 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 1380 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin A Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 473 neutralization units/mL |
Secondary
Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18
GMC of toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of assay results. CI for GMC were back transformations of a CI based on the Student t distribution for the mean logarithm of concentrations.
Time frame: Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 218 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 229 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 199 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 216 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 263 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 214 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 209 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 1 | 231 neutralization units/mL |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 247 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 1248 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 6255 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 1 | 177 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 570 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 662 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 656 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 447 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 2805 neutralization units/mL |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 1799 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 1071 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 1 | 191 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 4669 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 9549 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 909 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 2178 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 1029 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 2993 neutralization units/mL |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Concentration of Toxin B Specific Neutralizing Antibody Levels at Day 1, 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 702 neutralization units/mL |
Secondary
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18
GMFR in toxin A specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Time frame: Day 30, 37, 187 and Month 2, 6, 7, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 0.96 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 1.12 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 1.06 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 1.08 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 0.98 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 1.01 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 1.00 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 1.07 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 14.58 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 2.51 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 1.34 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 5.85 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 2.70 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 4.42 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 2.51 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 1.61 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 1.56 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 1.71 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 2.95 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 15.85 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 3.46 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 8.54 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 3.78 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin A Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 5.45 fold rise |
Secondary
Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18
GMFR for toxin B specific antibody levels was calculated using back transformations of the logarithmically transformed means of fold rise from baseline with assay results. CI for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise.
Time frame: Day 30, 37, 187 and Month 2, 6, 7, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 0.90 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 0.94 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 0.93 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 0.93 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 0.86 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 0.99 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 1.04 fold rise |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 1.11 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 3.71 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 10.19 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 2.53 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 15.85 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 35.43 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 3.28 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 3.75 fold rise |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 7.07 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2 | 5.38 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37 | 5.59 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30 | 4.75 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6 | 3.67 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12 | 15.54 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7 | 49.98 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187 | 24.44 fold rise |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Geometric Mean Fold Rise in Toxin B Specific Neutralizing Antibody Levels From Baseline at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18 | 11.21 fold rise |
Secondary
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18
Toxin A and toxin B antibodies were measured using neutralization assay.
Time frame: Day 30, 37, 187 and Month 2, 6, 7, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=4 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=4 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=8 fold rise | 68.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=4 fold rise | 11.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=4 fold rise | 58.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=32 fold rise | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=8 fold rise | 9.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=16 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=8 fold rise | 39.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=16 fold rise | 3.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=32 fold rise | 1.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=4 fold rise | 44.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=32 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=8 fold rise | 10.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=16 fold rise | 11.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=4 fold rise | 19.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=4 fold rise | 23.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=32 fold rise | 14.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=8 fold rise | 9.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=8 fold rise | 21.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=16 fold rise | 3.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=32 fold rise | 2.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=8 fold rise | 2.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=32 fold rise | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=16 fold rise | 41.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=32 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=4 fold rise | 18.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=4 fold rise | 84.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=16 fold rise | 5.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=8 fold rise | 10.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=4 fold rise | 8.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=16 fold rise | 3.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=16 fold rise | 3.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=16 fold rise | 7.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=32 fold rise | 3.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=4 fold rise | 10.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=32 fold rise | 1.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=8 fold rise | 6.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=8 fold rise | 74.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=16 fold rise | 2.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=32 fold rise | 1.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=4 fold rise | 36.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=4 fold rise | 69.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=32 fold rise | 17.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=8 fold rise | 50.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=16 fold rise | 27.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=8 fold rise | 19.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=32 fold rise | 10.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=4 fold rise | 87.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=4 fold rise | 12.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=16 fold rise | 52.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=8 fold rise | 9.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=16 fold rise | 3.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=16 fold rise | 7.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=32 fold rise | 3.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=4 fold rise | 58.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=4 fold rise | 26.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=8 fold rise | 19.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=16 fold rise | 8.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=8 fold rise | 35.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=32 fold rise | 3.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=4 fold rise | 24.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=8 fold rise | 14.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving>=4,>=8,>=16,>=32 Fold Rise From Baseline in Both Toxin A and Toxin B Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=16 fold rise | 9.7 percentage of participants |
Secondary
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18
Toxin A antibodies were measured using neutralization assay.
Time frame: Day 30, 37, 187 and Month 2, 6, 7, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=4 fold rise | 2.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=8 fold rise | 2.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=4 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=4 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=8 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=4 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=16 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=32 fold rise | 2.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=32 fold rise | 3.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=4 fold rise | 91.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=4 fold rise | 50.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=4 fold rise | 9.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=4 fold rise | 28.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=16 fold rise | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=8 fold rise | 6.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=16 fold rise | 9.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=4 fold rise | 28.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=16 fold rise | 1.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=32 fold rise | 2.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=32 fold rise | 2.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=4 fold rise | 14.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=4 fold rise | 27.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=16 fold rise | 47.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=32 fold rise | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=8 fold rise | 13.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=8 fold rise | 14.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=32 fold rise | 5.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=32 fold rise | 1.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=16 fold rise | 6.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=8 fold rise | 12.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=4 fold rise | 63.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=16 fold rise | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=8 fold rise | 16.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=8 fold rise | 76.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=32 fold rise | 20.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=8 fold rise | 27.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=8 fold rise | 43.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=16 fold rise | 5.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=16 fold rise | 6.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=8 fold rise | 78.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=4 fold rise | 14.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=16 fold rise | 10.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=32 fold rise | 6.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=4 fold rise | 40.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=8 fold rise | 26.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=16 fold rise | 12.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=32 fold rise | 7.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=4 fold rise | 36.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=8 fold rise | 21.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=16 fold rise | 12.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=4 fold rise | 12.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=16 fold rise | 5.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=32 fold rise | 2.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=4 fold rise | 71.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=8 fold rise | 55.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=16 fold rise | 32.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=32 fold rise | 13.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=4 fold rise | 91.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=16 fold rise | 56.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=32 fold rise | 21.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=4 fold rise | 61.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=8 fold rise | 40.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=16 fold rise | 14.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=32 fold rise | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=4 fold rise | 39.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=8 fold rise | 20.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=8 fold rise | 11.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=32 fold rise | 7.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=8 fold rise | 10.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin A Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=16 fold rise | 7.2 percentage of participants |
Secondary
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18
Toxin A antibodies were measured using neutralization assay.
Time frame: Day 30, 37, 187 and Month 2, 6, 7, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=4 fold rise | 3.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=8 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=16 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=4 fold rise | 3.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=8 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=16 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=4 fold rise | 3.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=8 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=32 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=4 fold rise | 3.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=8 fold rise | 3.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=16 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=4 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=8 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=16 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=4 fold rise | 3.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=8 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=16 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=32 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=4 fold rise | 3.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=8 fold rise | 3.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=4 fold rise | 7.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=8 fold rise | 3.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=16 fold rise | 2.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=32 fold rise | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=16 fold rise | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=16 fold rise | 3.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=8 fold rise | 68.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=4 fold rise | 34.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=8 fold rise | 21.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=32 fold rise | 55.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=8 fold rise | 29.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=8 fold rise | 32.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=16 fold rise | 52.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=16 fold rise | 21.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=32 fold rise | 6.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=32 fold rise | 32.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=32 fold rise | 16.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=8 fold rise | 44.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=4 fold rise | 75.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=4 fold rise | 36.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=4 fold rise | 30.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=4 fold rise | 92.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=8 fold rise | 30.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=4 fold rise | 66.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=32 fold rise | 13.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=16 fold rise | 23.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=4 fold rise | 79.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=8 fold rise | 59.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=32 fold rise | 18.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=8 fold rise | 84.7 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=32 fold rise | 18.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=4 fold rise | 37.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=16 fold rise | 29.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=16 fold rise | 39.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=16 fold rise | 23.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=16 fold rise | 76.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=16 fold rise | 13.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=32 fold rise | 16.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=32 fold rise | 22.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=32 fold rise | 23.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=4 fold rise | 41.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=8 fold rise | 32.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=32 fold rise | 27.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=16 fold rise | 21.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 6: >=32 fold rise | 12.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=4 fold rise | 87.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=4 fold rise | 78.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=8 fold rise | 78.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=8 fold rise | 39.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=16 fold rise | 63.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=8 fold rise | 60.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=4 fold rise | 93.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 187: >=32 fold rise | 46.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=8 fold rise | 90.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=16 fold rise | 83.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 18: >=16 fold rise | 40.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=4 fold rise | 43.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=8 fold rise | 38.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 7: >=32 fold rise | 66.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=16 fold rise | 30.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 30: >=32 fold rise | 20.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=4 fold rise | 47.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=4 fold rise | 85.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=8 fold rise | 42.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Day 37: >=16 fold rise | 33.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=32 fold rise | 23.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=8 fold rise | 73.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=4 fold rise | 47.5 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 2: >=16 fold rise | 29.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving >=4, >=8, >=16 and >=32 Fold Rise From Baseline in Toxin B Specific Antibody Levels at Day 30, 37, 187 and Month 2, 6, 7, 12, 18 | Month 12: >=16 fold rise | 51.6 percentage of participants |
Secondary
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18
Toxin A and toxin B antibodies were measured using neutralization assay.
Time frame: Day 1, 30, 37, 187 and Month 2, 6, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 30 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 37 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 2 | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 6 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 187 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 12 | 2.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 18 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 37 | 19.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 12 | 40.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 2 | 20.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 6 | 10.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 187 | 54.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 30 | 10.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 18 | 26.6 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 37 | 27.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 30 | 13.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1 | 0.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 2 | 27.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 12 | 50.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 187 | 63.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 6 | 11.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Both Toxin A and Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 18 | 32.9 percentage of participants |
Secondary
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18
Toxin B antibodies were measured using neutralization assay.
Time frame: Day 1, 30, 37, 187 and Month 2, 6, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 37 | 3.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 12 | 5.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 6 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 2 | 5.7 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 18 | 7.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 30 | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1 | 3.8 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 187 | 1.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 2 | 28.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 18 | 34.4 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1 | 2.5 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 30 | 25.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 37 | 28.8 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 6 | 19.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 187 | 58.0 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 12 | 44.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 6 | 27.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 30 | 36.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 12 | 56.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 187 | 63.9 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1 | 4.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 2 | 36.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 37 | 38.2 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for for Toxin B at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 18 | 47.4 percentage of participants |
Secondary
Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18
Toxin A antibodies were measured using neutralization assay.
Time frame: Day 1, 30, 37, 187 and Month 2, 6, 12, 18
Population: Evaluable immunogenicity population: all eligible participants randomized to study, received all 3 study vaccinations to which they were randomized, had at least 1 valid assay result from blood drawn within 20 to 45 days after Vaccination 3 and had no major protocol violations.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1 | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 30 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 37 | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 2 | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 6 | 1.9 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 187 | 0.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 12 | 2.0 percentage of participants |
| Placebo: Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 18 | 3.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 37 | 43.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 12 | 71.9 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 2 | 41.1 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 6 | 15.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 187 | 80.2 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1 | 0.6 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 30 | 17.3 percentage of participants |
| Clostridium Difficile Vaccine(100 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 18 | 48.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 37 | 56.7 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 30 | 19.1 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 1 | 1.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 2 | 57.0 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 12 | 77.4 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Day 187 | 84.8 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 6 | 20.3 percentage of participants |
| Clostridium Difficile Vaccine(200 mcg):Day 1, 8 and 30 Regimen | Month 0, 1 and 6 Regimen: Percentage of Participants Achieving Prespecified Antibody Titer Level for Toxin A at Day 1, 30, 37, 187 and Month 2, 6, 12, 18 | Month 18 | 53.3 percentage of participants |