Clostridium Difficile Associated Disease
Conditions
Keywords
Clostridium difficile, vaccine
Brief summary
This study will investigate a Clostridium difficile vaccine in healthy adults aged 50 to 85 years, who will each receive 3 doses of vaccine. The study will assess the safety and tolerability of the vaccine, and also look at the subjects' immune response to the vaccine.
Interventions
BIOLOGICALClostridium difficile vaccine
0.5 mL intramuscular injection on day 1, day 8, and day 30.
BIOLOGICALPlacebo
Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy male and female subjects aged 50 to 85 years
Exclusion criteria
Proven or suspected prior episode of Clostridium difficile associated diarrhea. Unstable chronic medical condition or disease requiring significant change in therapy or hospitalization for worsening disease within 8 weeks before receipt of study vaccine. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | From Day of Dose 1 vaccination to within 7 days after Dose 1 | Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness. |
| Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | From Day of Dose 2 vaccination to within 14 days after Dose 2 | Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness. |
| Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | From Day of Dose 3 vaccination to within 14 days after Dose 3 | Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness. |
| Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | From Day of Dose 1 vaccination to within 7 days of Dose 1 | Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain. |
| Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | From Day of Dose 2 vaccination to within 14 days after Dose 2 | Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain. |
| Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | From Day of Dose 3 vaccination to within 14 days after Dose 3 | Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain. |
| Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort) | AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13) | An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization. |
| Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | From Day of Dose 1 vaccination to within 7 days of Dose 1 | Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness. |
| Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | From Day of Dose 2 vaccination to 14 days after Dose 2 | Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness. |
| Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | From Day of Dose 3 vaccination to 14 days after Dose 3 | Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness. |
| Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | From Day of Dose 1 vaccination to within 7 days of Dose 1 | Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain. |
| Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | From Day of Dose 2 vaccination to within 14 days after Dose 2 | Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain. |
| Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | From Day of Dose 3 vaccination to within 14 days after Dose 3 | Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain. |
| Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort) | AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13) | An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization. |
Countries
United States
Participant flow
Pre-assignment details
In Stage 1, 42 participants aged 50 to 64 years were randomized. After at least 14 days of post-Dose 2 blinded safety data for all Stage 1 participants was reviewed and determined safe, the study proceeded to Stage 2, during which 143 participants aged 65 to 85 years were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations. | 27 |
| Clostridium Difficile Vaccine, 100 µg Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations. | 79 |
| Clostridium Difficile Vaccine, 200 µg Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations. | 78 |
| Total | 184 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Stage 1 Participants Aged 50 to 64 Years | Lost to Follow-up | 1 | 1 | 0 |
| Stage 1 Participants Aged 50 to 64 Years | Withdrawal by Subject | 0 | 2 | 1 |
| Stage 2 Participants Aged 65 to 85 Years | Death | 0 | 0 | 1 |
| Stage 2 Participants Aged 65 to 85 Years | Lost to Follow-up | 1 | 2 | 2 |
| Stage 2 Participants Aged 65 to 85 Years | Protocol Violation | 0 | 0 | 1 |
| Stage 2 Participants Aged 65 to 85 Years | Withdrawal by Subject | 0 | 0 | 2 |
| Stage 2 Participants Aged 65 to 85 Years | Withdrew before vaccination | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Clostridium Difficile Vaccine, 100 µg | Clostridium Difficile Vaccine, 200 µg | Total |
|---|---|---|---|---|
| Age, Customized Ages 50 to 64 years | 6 Participants | 18 Participants | 18 Participants | 42 Participants |
| Age, Customized Ages 65 to 85 years | 21 Participants | 61 Participants | 60 Participants | 142 Participants |
| Sex/Gender, Customized Ages 50 to 64 years: Female | 1 Participants | 5 Participants | 9 Participants | 15 Participants |
| Sex/Gender, Customized Ages 50 to 64 years: Male | 5 Participants | 13 Participants | 9 Participants | 27 Participants |
| Sex/Gender, Customized Ages 65 to 85 years: Female | 13 Participants | 37 Participants | 36 Participants | 86 Participants |
| Sex/Gender, Customized Ages 65 to 85 years: Male | 8 Participants | 24 Participants | 24 Participants | 56 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 |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 5 / 18 | 9 / 18 | 5 / 21 | 22 / 61 | 22 / 60 |
| serious Total, serious adverse events | 1 / 6 | 2 / 18 | 0 / 18 | 3 / 21 | 2 / 61 | 6 / 60 |
Outcome results
Primary
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort)
An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.
Time frame: AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)
Population: All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort) | AEs | 16.7 Participants |
| Placebo | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort) | SAEs | 16.7 Participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort) | AEs | 33.3 Participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort) | SAEs | 11.1 Participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort) | AEs | 50.0 Participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (50- to 64-Year Age Cohort) | SAEs | 0 Participants |
Primary
Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort)
An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. An SAE is any untoward medical occurrence at any dose that results in death, persistent or significant disability/incapacity, or congenital anomaly/birth defect; is life-threatening; or requires or prolongs inpatient hospitalization.
Time frame: AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)
Population: All randomized participants aged 65 to 85 who received at least 1 dose of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort) | AEs | 38.1 Percentage of participants |
| Placebo | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort) | SAEs | 14.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort) | AEs | 36.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort) | SAEs | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort) | AEs | 41.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Adverse Events (AEs) to Month 2 and Serious AEs (SAEs) to Month 13 (65- to 85-Year Age Cohort) | SAEs | 10.0 Percentage of participants |
Primary
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort)
Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.
Time frame: From Day of Dose 2 vaccination to within 14 days after Dose 2
Population: All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Moderate | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Any | 61.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Mild | 44.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Moderate | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Any | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Any | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Any | 61.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Mild | 44.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Mild | 55.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Mild | 27.8 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Any | 50.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Any | 83.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Any | 66.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Mild | 55.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Any | 27.8 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Pain at injection site: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Mild | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Any local reaction: Moderate | 27.8 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Swelling: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 2 (50- to 64-Year Age Cohort) | Redness: Moderate | 22.2 Percentage of participants |
Primary
Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)
Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.
Time frame: From Day of Dose 3 vaccination to within 14 days after Dose 3
Population: All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Any | 23.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Mild | 23.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Any | 23.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Mild | 23.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Mild | 38.9 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Mild | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Any | 44.4 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Any | 55.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Any | 44.4 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Mild | 27.8 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Any | 33.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Pain at injection site: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any local reaction: Moderate | 27.8 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Swelling: Moderate | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Redness: Moderate | 22.2 Percentage of participants |
Primary
Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)
Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.
Time frame: From Day of Dose 1 vaccination to within 7 days after Dose 1
Population: All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Any | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Mild | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Any | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Mild | 50.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Any | 55.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Any | 50.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Mild | 44.4 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Any | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any local reaction: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Swelling: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Prespecified Local Reactions Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Redness: Mild | 0.0 Percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort)
Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.
Time frame: From Day of Dose 3 vaccination to within 14 days after Dose 3
Population: All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Any | 33.3 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Moderate | 33.3 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Moderate | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Any | 33.3 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Moderate | 33.3 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Mild | 11.8 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Any | 29.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Moderate | 23.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Mild | 23.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Moderate | 11.8 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Moderate | 5.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Any | 23.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Mild | 5.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Moderate | 17.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Any | 23.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Any | 52.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Mild | 17.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Moderate | 5.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Mild | 29.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Any | 41.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Any | 23.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Mild | 29.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Moderate | 11.8 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Any | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Any | 61.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Any | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Severe | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Any | 27.8 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Severe | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Diarrhea: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Any systemic event: Mild | 44.4 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Any | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | Vomiting: Mild | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (50- to 64-Year Age Cohort) | New/worsening joint pain: Any | 11.1 Percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)
Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.
Time frame: From Day of Dose 3 vaccination to within 14 days after Dose 3
Population: All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Any | 25.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Severe | 25.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Any | 25.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Mild | 25.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Any | 50.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Mild | 25.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Severe | 25.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Mild | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Any | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Moderate | 25.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Moderate | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Moderate | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Any | 33.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Mild | 25.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Moderate | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Any | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Any | 50.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Mild | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Moderate | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Mild | 25.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Any | 25.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Any | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Any | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Mild | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Any | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Mild | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Diarrhea: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any systemic event: Mild | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | New/worsening joint pain: Any | 0.0 Percentage of participants |
Primary
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)
Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.
Time frame: From Day of Dose 1 vaccination to within 7 days of Dose 1
Population: All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/ worsening muscle pain: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Any | 44.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Mild | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Any | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Any | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Moderate | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Any | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/ worsening muscle pain: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Any | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Any | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Mild | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Moderate | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Mild | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Moderate | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Mild | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Any | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Diarrhea: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/ worsening muscle pain: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Headache: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Any | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort) | Any systemic event: Mild | 5.6 Percentage of participants |
Primary
Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort)
Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.
Time frame: From Day of Dose 2 vaccination to 14 days after Dose 2
Population: All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Any | 5.9 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Mild | 5.9 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Any | 5.9 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Mild | 5.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Moderate | 24.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Any | 66.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Mild | 45.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Moderate | 18.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Severe | 1.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Any | 22.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Mild | 9.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Moderate | 5.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Severe | 7.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Any | 26.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Mild | 11.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Moderate | 9.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Severe | 5.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Any | 67.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Mild | 34.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Severe | 9.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Mild | 48.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Severe | 2.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Mild | 8.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Any | 30.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Severe | 6.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Any | 70.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Any | 64.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Mild | 34.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Severe | 2.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Any | 26.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Pain at injection site: Moderate | 14.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Mild | 12.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Severe | 4.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Any local reaction: Moderate | 30.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Swelling: Moderate | 12.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 2 (65- to 85-Year Age Cohort) | Redness: Moderate | 18.0 Percentage of participants |
Primary
Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort)
Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.
Time frame: From Day of Dose 3 vaccination to 14 days after Dose 3
Population: All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Moderate | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Any | 25.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Moderate | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Any | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Moderate | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Any | 25.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Moderate | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Any | 33.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Mild | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Any | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Any | 25.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Any | 25.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Any | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Pain at injection site: Moderate | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Any local reaction: Moderate | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 14 Days After Dose 3 (65- to 85-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
Primary
Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)
Pain at injection site: mild=does not interfere with activity; moderate=interferes with activity; severe=prevents daily activity; Grade 4=emergency department visit or hospitalization. Redness/swelling: Mild=2.5 to 5.0 cm; moderate= \>5.0 to 10.0 cm; severe= \>10 cm; Grade 4=necrosis or exfoliative dermatitis for redness category and only necrosis for swelling category. Any local reaction=any pain at the injection site, any swelling, or any redness.
Time frame: From Day of Dose 1 vaccination to within 7 days of Dose 1
Population: All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Any | 9.5 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Any | 9.5 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Mild | 9.5 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Mild | 9.5 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Moderate | 1.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Any | 24.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Mild | 21.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Moderate | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Any | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Mild | 1.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Moderate | 4.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Any | 27.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Mild | 23.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Any | 5.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Mild | 26.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Mild | 1.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Moderate | 1.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Any | 31.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Moderate | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Mild | 28.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Any | 30.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Moderate | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Mild | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Moderate | 5.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Any | 6.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Swelling: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Redness: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Pain at injection site: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Local Reaction Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any local reaction: Grade 4 | 0.0 Percentage of participants |
Primary
Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort)
Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.
Time frame: From Day of Dose 2 vaccination to within 14 days after Dose 2
Population: All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Any | 33.3 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Moderate | 16.7 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Any | 16.7 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/ worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Any | 33.3 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Mild | 16.7 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Moderate | 16.7 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Mild | 27.8 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Any | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Moderate | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Any | 38.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Grade 4 | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Moderate | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/ worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Grade 4 | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Any | 27.8 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Any | 44.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Mild | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Moderate | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Any | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Any | 33.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Mild | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Moderate | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Mild | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Any | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Any | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Any | 55.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Any | 33.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Mild | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Mild | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Moderate | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Moderate | 22.2 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Any | 33.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Severe | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Mild | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Moderate | 16.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Diarrhea: Mild | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/ worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Severe | 5.6 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Any systemic event: Mild | 27.8 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening muscle pain: Any | 11.1 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 14 Days of Dose 2 (50- to 64-Year Age Cohort) | New/worsening joint pain: Any | 0.0 Percentage of participants |
Primary
Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort)
Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.
Time frame: From Day of Dose 2 vaccination to within 14 days after Dose 2
Population: All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Any | 23.5 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Mild | 5.9 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Moderate | 17.6 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Any | 23.5 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Mild | 17.6 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Moderate | 5.9 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Any | 17.6 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Mild | 11.8 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Moderate | 5.9 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Any | 11.8 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Moderate | 11.8 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Any | 11.8 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Moderate | 11.8 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Any | 35.3 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Mild | 5.9 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Moderate | 29.4 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Mild | 13.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Any | 26.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Moderate | 32.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Mild | 17.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Moderate | 7.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Moderate | 9.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Any | 39.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Mild | 20.8 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Moderate | 18.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Severe | 1.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Any | 26.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Any | 50.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Mild | 17.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Any | 1.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Moderate | 9.4 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Severe | 1.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Any | 1.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Mild | 1.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Mild | 17.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Any | 17.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Any | 20.8 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Mild | 7.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Moderate | 9.4 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Mild | 14.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Severe | 2.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Any | 18.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Any | 4.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Mild | 10.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Any | 58.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Any | 14.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Moderate | 2.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Mild | 2.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Mild | 12.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Moderate | 2.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Moderate | 4.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Moderate | 20.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Moderate | 10.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Severe | 2.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Any | 32.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Severe | 4.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Mild | 20.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Moderate | 12.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Diarrhea: Mild | 16.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Any | 2.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Any systemic event: Mild | 34.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Any | 24.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With a Systemic Event Within 14 Days of Dose 2 (65- to 85-Year Age Cohort) | New/worsening joint pain: Any | 14.0 Percentage of participants |
Primary
Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort)
Fever=temperature ≥38.0°C (100.4°C): Mild=38.0°C to 38.4°C (100.4°F-101.1°F); moderate=38.5°C to 38.9°C (101.2°F-102.0°F); severe=39.0°C to 40.0°C (102.1°F-104.0°F); Grade 4= \>40.0°C (\>104.0°F). Vomiting: Mild=1 to 2 times in 24 hours; moderate= \>2 times in 24 hours; severe=requires intravenous hydration; Grade 4=emergency department visit or hospitalization for hypotensive shock. Diarrhea: Mild=2 to 3 loose stools in 24 hours; moderate=4 to 5 loose stools in 24 hours; severe= ≥6 loose stools in 24 hours; Grade 4=emergency department visit or hospitalization. Headache, fatigue, new or worsening joint or muscle pain: Mild=no interference with activity; moderate=some interference with activity; severe=significant interference with activity, prevents daily activity; Grade 4=emergency department visit or hospitalization. Any systemic event: Fever ≥38.0°C, vomiting, diarrhea, headache, fatigue, or new or worsening muscle or joint pain.
Time frame: From Day of Dose 1 vaccination to within 7 days of Dose 1
Population: All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Any | 4.8 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Mild | 4.8 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Any | 9.5 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Mild | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Moderate | 9.5 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Any | 19.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Mild | 14.3 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Moderate | 4.8 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Any | 19.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Mild | 4.8 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Moderate | 14.3 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Any | 4.8 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Mild | 4.8 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Moderate | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Any | 23.8 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Mild | 4.8 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Moderate | 19.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Placebo | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Mild | 1.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Any | 13.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Moderate | 11.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Mild | 13.1 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Moderate | 6.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Any | 26.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Mild | 18.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Moderate | 8.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Any | 4.9 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Any | 32.8 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Mild | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Moderate | 1.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Any | 1.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Mild | 1.6 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Mild | 21.3 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Any | 11.5 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Any | 8.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Mild | 8.2 Percentage of participants |
| Clostridium Difficile Vaccine, 100 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Moderate | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Mild | 6.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Any | 15.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Any | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Mild | 5.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Any | 45.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Any | 15.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Mild | 1.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Mild | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Moderate | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Moderate | 6.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Moderate | 3.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Moderate | 1.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Moderate | 20.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Moderate | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Headache: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Any | 26.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Severe | 1.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Mild | 13.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fever: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Moderate | 13.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Diarrhea: Mild | 11.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Severe | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Any | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Fatigue: Grade 4 | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Severe | 1.7 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Any systemic event: Mild | 23.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening muscle pain: Any | 8.3 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | Vomiting: Mild | 0.0 Percentage of participants |
| Clostridium Difficile Vaccine, 200 µg | Percentage of Participants With A Systemic Event Within 7 Days of Dose 1 (65- to 85-Year Age Cohort) | New/worsening joint pain: Any | 8.3 Percentage of participants |