A Study To Investigate A Clostridium Difficile Vaccine In... | NCT02117570 | Trialant
NCT02117570
Sponsor
Pfizer
Status
Completed
Last Update Posted
Jan 30, 2017Estimated
Enrollment
185Actual
Phase
Phase 2
Conditions
Clostridium Difficile Associated Disease
Interventions
Clostridium difficile vaccine
Clostridium difficile vaccine
Placebo
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT02117570
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
B5091003
Secondary IDs
ID
Type
Description
Link
2013-004764-58
EudraCT Number
Brief Title
A Study To Investigate A Clostridium Difficile Vaccine In Healthy Adults Aged 50 to 85 Years, Who Will Each Receive 3 Doses Of Vaccine.
Official Title
A Phase 2, Placebo-controlled, Randomised, Observer-blinded Trial To Evaluate The Safety, Tolerability And Immunogenicity Of A Clostridium Difficile Vaccine Administered As A 3-dose Regimen In Healthy Adults Aged 50 To 85 Years
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Nov 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 2014
Primary Completion Date
Dec 2015Actual
Completion Date
Dec 2015Actual
First Submitted Date
Apr 16, 2014
First Submission Date that Met QC Criteria
Apr 16, 2014
First Posted Date
Apr 21, 2014Estimated
Results Waived
Not provided
Results First Submitted Date
Dec 5, 2016
Results First Submitted that Met QC Criteria
Dec 5, 2016
Results First Posted Date
Jan 30, 2017Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Dec 5, 2016
Last Update Posted Date
Jan 30, 2017Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Detailed Description
Not provided
Conditions Module
Conditions
Clostridium Difficile Associated Disease
Keywords
Clostridium difficile
vaccine
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
185Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
High dose of C. difficile vaccine
Experimental
Biological: Clostridium difficile vaccine
Low dose of C. difficile vaccine
Experimental
Biological: Clostridium difficile vaccine
Placebo
Placebo Comparator
Biological: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Clostridium difficile vaccine
Biological
0.5 mL intramuscular injection on day 1, day 8, and day 30.
High dose of C. difficile vaccine
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
From Day of Dose 1 vaccination to within 7 days after Dose 1
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.
From Day of Dose 2 vaccination to within 14 days after Dose 2
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.
From Day of Dose 3 vaccination to within 14 days after Dose 3
Percentage of Participants Reporting Systemic Events Within 7 Days After Dose 1 (50- to 64-Year Age Cohort)
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
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.
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
50 Years
Maximum Age
85 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Pfizer CT.gov Call Center
Pfizer
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Avail Clinical Research, LLC
DeLand
Florida
32720
United States
Meridian Clinical Research
References Module
Citations
Not provided
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
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.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
FG001
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.
Periods
Title
Milestones
Reasons Not Completed
Stage 1 Participants Aged 50 to 64 Years
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
1
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Prevention
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Triple
Masking Description
Not provided
Who Masked
ParticipantInvestigatorOutcomes Assessor
Clostridium difficile vaccine
Biological
0.5 mL intramuscular injection on day 1, day 8, and day 30.
Low dose of C. difficile vaccine
Placebo
Biological
Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.
Placebo
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.
From Day of Dose 1 vaccination to within 7 days of Dose 1
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.
From Day of Dose 2 vaccination to within 14 days after Dose 2
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.
From Day of Dose 3 vaccination to within 14 days after Dose 3
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.
AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)
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.
From Day of Dose 1 vaccination to within 7 days of Dose 1
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.
From Day of Dose 2 vaccination to 14 days after Dose 2
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.
From Day of Dose 3 vaccination to 14 days after Dose 3
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.
From Day of Dose 1 vaccination to within 7 days of Dose 1
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.
From Day of Dose 2 vaccination to within 14 days after Dose 2
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.
From Day of Dose 3 vaccination to within 14 days after Dose 3
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.
AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)
Savannah
Georgia
31406
United States
Clinical Research Atlanta
Stockbridge
Georgia
30281
United States
Meridian Clinical Research
Norfolk
Nebraska
68701
United States
Meridian Clinical Research, LLC
Omaha
Nebraska
68134
United States
Clinical Research Center of Nevada, LLC
Las Vegas
Nevada
89104
United States
PMG Research of Charlotte
Charlotte
North Carolina
28209
United States
PMG Research of Wilmington, LLC
Wilmington
North Carolina
28401
United States
PMG Research of Winston-Salem
Winston-Salem
North Carolina
27103
United States
Benchmark Research
Austin
Texas
78705
United States
Benchmark Research
San Angelo
Texas
76904
United States
Clinical Trials of Texas, Inc.
San Antonio
Texas
78229
United States
FG002
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.
FG0006 subjectsRandomized
FG00118 subjectsRandomized
FG00218 subjectsRandomized
Vaccine: Dose 1
FG0006 subjects
FG00118 subjects
FG00218 subjects
Vaccine: Dose 2
FG0006 subjects
FG00118 subjects
FG00218 subjects
Vaccine: Dose 3
FG0006 subjects
FG00117 subjects
FG00218 subjects
COMPLETED
FG0005 subjects
FG00115 subjects
FG00217 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0021 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0012 subjects
FG0021 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0020 subjects
Stage 2 Participants Aged 65 to 85 Years
Type
Comment
Milestone Data
STARTED
FG00021 subjectsRandomized
FG00162 subjectsRandomized
FG00260 subjectsRandomized
Vaccine: Dose 1
FG00021 subjects
FG00161 subjects
FG00260 subjects
Vaccine: Dose 2
FG00017 subjects
FG00153 subjects
FG00250 subjects
Vaccine: Dose 3
FG0004 subjects
FG00112 subjects
FG00212 subjects
COMPLETED
FG00020 subjects
FG00159 subjects
FG00254 subjects
NOT COMPLETED
FG0001 subjects
FG0013 subjects
FG0026 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0022 subjects
Death
FG000
All participants who received at least 1 vaccination
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
BG001
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.
BG002
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.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00027
BG00179
BG00278
BG003184
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Customized
Number
Participants
Title
Denominators
Categories
Ages 50 to 64 years
Title
Measurements
BG0006
BG00118
BG00218
BG003
Sex/Gender, Customized
Number
Participants
Title
Denominators
Categories
Ages 50 to 64 years: Female
Title
Measurements
BG0001
BG0015
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
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.
All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 1 vaccination to within 7 days after Dose 1
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
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.
OG002
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.
Units
Counts
Participants
OG0006
OG00118
OG00218
Title
Denominators
Categories
Pain at injection site: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00116.7(3.6 to 41.4)
OG00250.0(26.0 to 74.0)
Pain at injection site: Mild
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.
All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 2 vaccination to within 14 days after Dose 2
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
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.
OG002
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.
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.
All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 3 vaccination to within 14 days after Dose 3
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
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.
OG002
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.
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.
All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 1 vaccination to within 7 days of Dose 1
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
Clostridium Difficile Vaccine, 100 µg
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.
All randomized participants aged 50 to 64 years who received at least 2 doses of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 2 vaccination to within 14 days after Dose 2
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
Clostridium Difficile Vaccine, 100 µg
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.
All randomized participants aged 50 to 64 years who received all 3 doses of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 3 vaccination to within 14 days after Dose 3
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
Clostridium Difficile Vaccine, 100 µg
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.
All randomized participants aged 50 to 64 years who received at least 1 dose of study vaccine
Posted
Number
95% Confidence Interval
Participants
AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
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.
OG002
Clostridium Difficile Vaccine, 200 µg
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.
All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine.
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 1 vaccination to within 7 days of Dose 1
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
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.
OG002
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.
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.
All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 2 vaccination to 14 days after Dose 2
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
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.
OG002
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.
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.
All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 3 vaccination to 14 days after Dose 3
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
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.
OG002
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.
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.
All randomized participants aged 65 to 85 years who received at least 1 dose of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 1 vaccination to within 7 days of Dose 1
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
Clostridium Difficile Vaccine, 100 µg
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.
All randomized participants aged 65 to 85 years who received at least 2 doses of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 2 vaccination to within 14 days after Dose 2
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
Clostridium Difficile Vaccine, 100 µg
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.
All randomized participants aged 65 to 85 years who received all 3 doses of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
From Day of Dose 3 vaccination to within 14 days after Dose 3
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
Clostridium Difficile Vaccine, 100 µg
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.
All randomized participants aged 65 to 85 who received at least 1 dose of study vaccine
Posted
Number
95% Confidence Interval
Percentage of participants
AEs: From informed consent to Visit 6 (Month 2). SAEs: From informed consent to Visit 9 (Month 13)
ID
Title
Description
OG000
Placebo
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG001
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.
OG002
Clostridium Difficile Vaccine, 200 µg
Time Frame
Adverse events (AEs) were assessed from informed consent through and including Visit 6 (Month 2). Serious AEs (SAEs) were assessed from informed consent through and including Visit 9.
Description
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo (50-64 Year Age Cohort)
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
1
6
0
6
EG001
Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort)
Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
2
18
5
18
EG002
Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort)
Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
0
18
9
18
EG003
Placebo (65-85 Year Age Cohort)
Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
3
21
5
21
EG004
Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort)
Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
2
61
22
61
EG005
Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort)
Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
6
60
22
60
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cellulitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG0030 affected21 at risk
EG0040 affected61 at risk
EG0050 affected60 at risk
Gangrene
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Breast Cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0001 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Sinus arrest
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Device breakage
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Device malfunction
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 events0 affected6 at risk
EG0010 events0 affected18 at risk
EG0020 events0 affected18 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Nausea
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG0030 affected21 at risk
EG0040 affected61 at risk
EG0051 affected60 at risk
Fatigue
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Injection site erythema
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0023 affected18 at risk
EG003
Injection site pruritus
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Localised infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Otitis media
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Sinusitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Cervical radiculopathy
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Headache
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0011 affected18 at risk
EG0020 affected18 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0021 affected18 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cardiac arrest
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Sinus arrest
Cardiac disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Influenza like illness
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Injection site bruising
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Injection site induration
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Injection site pain
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Injection site rash
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Injection site reaction
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Injection site swelling
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pain
General disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Bronchitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Influenza
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Skin candida
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Excoriation
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Musculoskeletal pain
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Dizziness
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Sciatica
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Seizure
Nervous system disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Device malfunction
Injury, poisoning and procedural complications
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Sinus operation
Surgical and medical procedures
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Hypertension
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Hypotension
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Lymphoedema
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Orthostatic hypotension
Vascular disorders
MedDRA version 19.0
Systematic Assessment
EG0000 affected6 at risk
EG0010 affected18 at risk
EG0020 affected18 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc
1-800-718-1021
0 subjects
FG0010 subjects
FG0021 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0021 subjects
Lost to Follow-up
FG0001 subjects
FG0012 subjects
FG0022 subjects
Withdrew before vaccination
FG0000 subjects
FG0011 subjects
FG0020 subjects
42
Ages 65 to 85 years
Title
Measurements
BG00021
BG00161
BG00260
BG003142
9
BG00315
Ages 50 to 64 years: Male
Title
Measurements
BG0005
BG00113
BG0029
BG00327
Ages 65 to 85 years: Female
Title
Measurements
BG00013
BG00137
BG00236
BG00386
Ages 65 to 85 years: Male
Title
Measurements
BG0008
BG00124
BG00224
BG00356
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00116.7(3.6 to 41.4)
OG00250.0(26.0 to 74.0)
Pain at injection site: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Pain at injection site: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Pain at injection site: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Redness: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.6(0.1 to 27.3)
OG0025.6(0.1 to 27.3)
Redness: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.6(0.1 to 27.3)
OG0020.0(0.0 to 18.5)
Redness: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0025.6(0.1 to 27.3)
Redness: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Redness: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Swelling: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG00216.7(3.6 to 41.4)
Swelling: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG00211.1(1.4 to 34.7)
Swelling: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0025.6(0.1 to 27.3)
Swelling: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Swelling: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Any local reaction: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00116.7(3.6 to 41.4)
OG00255.6(30.78 to 78.5)
Any local reaction: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00116.7(3.6 to 41.4)
OG00244.4(21.5 to 69.2)
Any local reaction: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG00211.1(1.4 to 34.7)
Any local reaction: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Any local reaction: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Units
Counts
Participants
OG0006
OG00118
OG00218
Title
Denominators
Categories
Pain at injection site: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00161.1(35.7 to 82.7)
OG00266.7(41.0 to 86.7)
Pain at injection site: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00144.4(21.5 to 69.2)
OG00255.6(30.8 to 78.5)
Pain at injection site: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00116.7(3.6 to 41.4)
OG00211.1(1.4 to 34.7)
Pain at injection site: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Pain at injection site: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Redness: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00111.1(1.4 to 34.7)
OG00250.0(26.0 to 74.0)
Redness: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00111.1(1.4 to 34.7)
OG00227.8(9.7 to 53.5)
Redness: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG00222.2(6.4 to 47.6)
Redness: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Redness: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Swelling: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.1(1.4 to 34.7)
OG00227.8(9.7 to 53.5)
Swelling: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.1(1.4 to 34.7)
OG00222.2(6.4 to 47.6)
Swelling: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0025.6(0.1 to 27.3)
Swelling: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Swelling: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Any local reaction: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00161.1(35.7 to 82.7)
OG00283.3(58.6 to 96.4)
Any local reaction: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00144.4(21.5 to 69.2)
OG00255.6(30.8 to 78.5)
Any local reaction: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00116.7(3.6 to 41.4)
OG00227.8(9.7 to 53.5)
Any local reaction: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Any local reaction: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Units
Counts
Participants
OG0006
OG00117
OG00218
Title
Denominators
Categories
Pain at injection site: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00123.5(6.8 to 49.9)
OG00244.4(21.5 to 69.2)
Pain at injection site: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00123.5(6.8 to 49.9)
OG00238.9(17.3 to 64.3)
Pain at injection site: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0025.6(0.1 to 27.3)
Pain at injection site: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Pain at injection site: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Redness: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG00244.4(21.5 to 69.2)
Redness: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG00222.2(6.4 to 47.6)
Redness: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG00222.2(6.4 to 47.6)
Redness: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Redness: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Swelling: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG00233.3(13.3 to 59.0)
Swelling: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG00216.7(3.6 to 41.4)
Swelling: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG00216.7(3.6 to 41.4)
Swelling: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Swelling: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Any local reaction: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00123.5(6.8 to 49.9)
OG00255.6(30.8 to 78.5)
Any local reaction: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00123.5(6.8 to 49.9)
OG00227.8(9.7 to 53.5)
Any local reaction: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG00227.8(9.7 to 53.5)
Any local reaction: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Any local reaction: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG002
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.
Units
Counts
Participants
OG0006
OG00118
OG00218
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fever: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fever: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fever: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fever: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Vomiting: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG0015.6(0.1 to 27.3)
OG0020.0(0.0 to 18.5)
Vomiting: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG0015.6(0.1 to 27.3)
OG0020.0(0.0 to 18.5)
Vomiting: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Vomiting: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Vomiting: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Diarrhea: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00122.2(6.4 to 47.6)
OG0025.6(0.1 to 27.3)
Diarrhea: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00122.2(6.4 to 47.6)
OG0020.0(0.0 to 18.5)
Diarrhea: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0025.6(0.1 to 27.3)
Diarrhea: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Diarrhea: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Headache: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00116.7(3.6 to 41.4)
OG0025.6(0.1 to 27.3)
Headache: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00116.7(3.6 to 41.4)
OG0020.0(0.0 to 18.5)
Headache: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0025.6(0.1 to 27.3)
Headache: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Headache: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fatigue: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00122.2(6.4 to 47.6)
OG00211.1(1.4 to 34.7)
Fatigue: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0025.6(0.1 to 27.3)
Fatigue: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00122.2(6.4 to 47.6)
OG0025.6(0.1 to 27.3)
Fatigue: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fatigue: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
New/worsening muscle pain: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.1(1.4 to 34.7)
OG0020.0(0.0 to 18.5)
New/worsening muscle pain: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0 to 18.5)
OG0020.0(0.0 to 18.5)
New/ worsening muscle pain: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.1(1.4 to 34.7)
OG0020.0(0.0 to 18.5)
New/worsening muscle pain: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
New/worsening muscle pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.1(1.4 to 34.7)
OG0025.6(0.1 to 27.3)
New/worsening joint pain: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.1(1.4 to 34.7)
OG0025.6(0.1 to 27.3)
New/worsening joint pain: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Any systemic event: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00144.4(21.5 to 69.2)
OG00222.2(6.4 to 47.6)
Any systemic event: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00122.2(6.4 to 47.6)
OG0025.6(0.1 to 27.3)
Any systemic event: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00122.2(6.4 to 47.6)
OG00216.7(3.6 to 41.4)
Any systemic event: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Any systemic event: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG002
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.
Units
Counts
Participants
OG0006
OG00118
OG00218
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.6(0.1 to 27.3)
OG0025.6(0.1 to 27.3)
Fever: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.6(0.1 to 27.3)
OG0025.6(0.1 to 27.3)
Fever: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fever: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fever: Grade 4
Title
Measurements
OG0000.0(0.0 to 49.5)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Vomiting: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Vomiting: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Vomiting: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Vomiting: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Vomiting: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Diarrhea: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.1(1.4 to 34.7)
OG00222.2(6.4 to 47.6)
Diarrhea: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.6(0.1 to 27.3)
OG00211.1(1.4 to 34.7)
Diarrhea: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.6(0.1 to 27.3)
OG00211.1(1.4 to 34.7)
Diarrhea: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Diarrhea: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Headache: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00122.2(6.4 to 47.6)
OG00233.3(13.3 to 59.0)
Headache: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.1(1.4 to 34.7)
OG00222.2(6.4 to 47.6)
Headache: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.1(1.4 to 34.7)
OG00211.1(1.4 to 34.7)
Headache: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Headache: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fatigue: Any
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00138.9(17.3 to 64.3)
OG00233.3(13.3 to 59.0)
Fatigue: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00116.7(3.6 to 41.4)
OG00216.7(3.6 to 41.4)
Fatigue: Moderate
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00116.7(3.6 to 41.4)
OG00216.7(3.6 to 41.4)
Fatigue: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Fatigue: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.6(0.1 to 27.3)
OG0020.0(0.0 to 18.5)
New/worsening muscle pain: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00127.8(9.7 to 53.5)
OG00211.1(1.4 to 34.7)
New/worsening muscle pain: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00111.1(1.4 to 34.7)
OG0025.6(0.1 to 27.3)
New/worsening muscle pain: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00116.7(3.6 to 41.4)
OG0020.0(0.0 to 18.5)
New/worsening muscle pain: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0025.6(0.1 to 27.3)
New/worsening muscle pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00133.3(13.3 to 59.0)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00127.8(9.7 to 53.5)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.6(0.1 to 27.3)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
New/ worsening joint pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0020.0(0.0 to 18.5)
Any systemic event: Any
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00144.4(21.5 to 69.2)
OG00255.6(30.8 to 78.5)
Any systemic event: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00116.7(3.6 to 41.4)
OG00227.8(9.7 to 53.5)
Any systemic event: Moderate
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00122.2(6.4 to 47.6)
OG00222.2(6.4 to 47.6)
Any systemic event: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 18.5)
OG0025.6(0.1 to 27.3)
Any systemic event: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.6(0.1 to 27.3)
OG0020.0(0.0 to 18.5)
Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG002
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.
Units
Counts
Participants
OG0006
OG00117
OG00218
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0025.6(0.1 to 27.3)
Fever: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Fever: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Fever: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0025.6(0.1 to 27.3)
Fever: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Vomiting: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0025.6(0.1 to 27.3)
Vomiting: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0025.6(0.1 to 27.3)
Vomiting: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Vomiting: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Vomiting: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Diarrhea: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00141.2(18.4 to 67.1)
OG00211.1(1.4 to 34.7)
Diarrhea: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00129.4(10.3 to 56.0)
OG00211.1(1.4 to 34.7)
Diarrhea: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.8(1.5 to 36.4)
OG0020.0(0.0 to 18.5)
Diarrhea: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Diarrhea: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Headache: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00129.4(10.3 to 56.0)
OG00211.1(1.4 to 34.7)
Headache: Mild
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00123.5(6.8 to 49.9)
OG00211.1(1.4 to 34.7)
Headache: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.9(0.1 to 28.7)
OG0020.0(0.0 to 18.5)
Headache: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Headache: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Fatigue: Any
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00123.5(6.8 to 49.9)
OG00227.8(9.7 to 53.5)
Fatigue: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0015.9(0.1 to 28.7)
OG00216.7(3.6 to 41.4)
Fatigue: Moderate
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00117.6(3.8 to 43.4)
OG00211.1(1.4 to 34.7)
Fatigue: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Fatigue: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
New/worsening muscle pain: Any
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00123.5(6.8 to 49.9)
OG00222.2(6.4 to 47.6)
New/worsening muscle pain: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00117.6(3.8 to 43.4)
OG00211.1(1.4 to 34.7)
New/worsening muscle pain: Moderate
Title
Measurements
OG00016.7(0.4 to 64.1)
OG0015.9(0.1 to 28.7)
OG00211.1(1.4 to 34.7)
New/worsening muscle pain: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
New/worsening muscle pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Any
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00123.5(6.8 to 49.9)
OG00211.1(1.4 to 34.7)
New/worsening joint pain: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.8(1.5 to 36.4)
OG00211.1(1.4 to 34.7)
New/worsening joint pain: Moderate
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00111.8(1.5 to 36.4)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
New/worsening joint pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Any systemic event: Any
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00152.9(27.8 to 77.0)
OG00261.1(35.7 to 82.7)
Any systemic event: Mild
Title
Measurements
OG0000.0(0.0 to 45.9)
OG00129.4(10.3 to 56.0)
OG00244.4(21.5 to 69.2)
Any systemic event: Moderate
Title
Measurements
OG00033.3(4.3 to 77.7)
OG00123.5(6.8 to 49.9)
OG00211.1(1.4 to 34.7)
Any systemic event: Severe
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0025.6(0.1 to 27.3)
Any systemic event: Grade 4
Title
Measurements
OG0000.0(0.0 to 45.9)
OG0010.0(0.0 to 19.5)
OG0020.0(0.0 to 18.5)
Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
Units
Counts
Participants
OG0006
OG00118
OG00218
Title
Denominators
Categories
AEs
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00133.3(13.3 to 59.0)
OG00250.0(26.0 to 74.0)
SAEs
Title
Measurements
OG00016.7(0.4 to 64.1)
OG00111.1(1.4 to 34.7)
OG0020(0.0 to 18.5)
Units
Counts
Participants
OG00021
OG00161
OG00260
Title
Denominators
Categories
Pain at injection site: Any
Title
Measurements
OG0009.5(1.2 to 30.4)
OG00124.6(14.5 to 37.3)
OG00230.0(18.8 to 43.2)
Pain at injection site: Mild
Title
Measurements
OG0009.5(1.2 to 30.4)
OG00121.3(11.9 to 33.7)
OG00228.3(17.5 to 41.4)
Pain at injection site: Moderate
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0013.3(0.4 to 11.3)
OG0021.7(0.0 to 8.9)
Pain at injection site: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Pain at injection site: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Redness: Any
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0026.7(1.8 to 16.2)
Redness: Mild
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0023.3(0.4 to 11.5)
Redness: Moderate
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0023.3(0.4 to 11.5)
Redness: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Redness: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Swelling: Any
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0013.3(0.4 to 11.3)
OG0025.0(1.0 to 13.9)
Swelling: Mild
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0011.6(0.0 to 8.8)
OG0021.7(0.0 to 8.9)
Swelling: Moderate
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0011.6(0.0 to 8.8)
OG0023.3(0.4 to 11.5)
Swelling: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Swelling: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Any local reaction: Any
Title
Measurements
OG0009.5(1.2 to 30.4)
OG00127.9(17.1 to 40.8)
OG00231.7(20.3 to 45.0)
Any local reaction: Mild
Title
Measurements
OG0009.5(1.2 to 30.4)
OG00123.0(13.2 to 35.5)
OG00226.7(16.1 to 39.7)
Any local reaction: Moderate
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0014.9(1.0 to 13.7)
OG0025.0(1.0 to 13.9)
Any local reaction: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Any local reaction: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Units
Counts
Participants
OG00017
OG00153
OG00250
Title
Denominators
Categories
Pain at injection site: Any
Title
Measurements
OG0005.9(0.1 to 28.7)
OG00166.0(51.7 to 78.5)
OG00264.0(49.2 to 77.1)
Pain at injection site: Mild
Title
Measurements
OG0005.9(0.1 to 28.7)
OG00145.3(31.6 to 59.6)
OG00248.0(33.7 to 62.6)
Pain at injection site: Moderate
Title
Measurements
OG0000.0(0.0 to 19.5)
OG00118.9(9.4 to 32.0)
OG00214.0(5.8 to 26.7)
Pain at injection site: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0011.9(0.0 to 10.1)
OG0022.0(0.1 to 10.6)
Pain at injection site: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Redness: Any
Title
Measurements
OG0000.0(0.0 to 19.5)
OG00122.6(12.3 to 36.2)
OG00230.0(17.9 to 44.6)
Redness: Mild
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0019.4(3.1 to 20.7)
OG0028.0(2.2 to 19.2)
Redness: Moderate
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0015.7(1.2 to 15.7)
OG00218.0(8.6 to 31.4)
Redness: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0017.5(2.1 to 18.2)
OG0024.0(0.5 to 13.7)
Redness: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Swelling: Any
Title
Measurements
OG0000.0(0.0 to 19.5)
OG00126.4(15.3 to 40.3)
OG00226.0(14.6 to 40.3)
Swelling: Mild
Title
Measurements
OG0000.0(0.0 to 19.5)
OG00111.3(4.3 to 23.0)
OG00212.0(4.5 to 24.3)
Swelling: Moderate
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0019.4(3.1 to 20.7)
OG00212.0(4.5 to 24.3)
Swelling: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0015.7(1.2 to 15.7)
OG0022.0(0.1 to 10.6)
Swelling: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Any local reaction: Any
Title
Measurements
OG0005.9(0.1 to 28.7)
OG00167.9(53.7 to 80.1)
OG00270.0(55.4 to 82.1)
Any local reaction: Mild
Title
Measurements
OG0005.9(0.1 to 28.7)
OG00134.0(21.5 to 48.3)
OG00234.0(21.2 to 48.8)
Any local reaction: Moderate
Title
Measurements
OG0000.0(0.0 to 19.5)
OG00124.5(13.8 to 38.3)
OG00230.0(17.9 to 44.6)
Any local reaction: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0019.4(3.1 to 20.7)
OG0026.0(1.3 to 16.5)
Any local reaction: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Units
Counts
Participants
OG0004
OG00112
OG00212
Title
Denominators
Categories
Pain at injection site: Any
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00125.0(5.5 to 57.2)
OG00225.0(5.5 to 57.2)
Pain at injection site: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00116.7(2.1 to 48.4)
OG00216.7(2.1 to 48.4)
Pain at injection site: Moderate
Title
Measurements
OG0000.0(0.0 to 600.2)
OG0018.3(0.2 to 38.5)
OG0028.3(0.2 to 38.5)
Pain at injection site: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Pain at injection site: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Redness: Any
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0018.3(0.2 to 38.5)
OG0028.3(0.2 to 38.5)
Redness: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0028.3(0.2 to 38.5)
Redness: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0018.3(0.2 to 38.5)
OG0020.0(0.0 to 26.5)
Redness: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Redness: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Swelling: Any
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00125.0(5.5 to 57.2)
OG00216.7(2.1 to 48.4)
Swelling: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00116.7(2.1 to 48.4)
OG00216.7(2.1 to 48.4)
Swelling: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0018.3(0.2 to 38.5)
OG0020.0(0.0 to 26.5)
Swelling: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Swelling: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Any local reaction: Any
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00133.3(9.9 to 65.1)
OG00225.0(5.5 to 57.2)
Any local reaction: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00116.7(2.1 to 48.4)
OG00216.7(2.1 to 48.4)
Any local reaction: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00116.7(2.1 to 48.4)
OG0028.3(0.2 to 38.5)
Any local reaction: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Any local reaction: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG002
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.
Units
Counts
Participants
OG00021
OG00161
OG00260
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0023.3(0.4 to 11.5)
Fever: Mild
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0021.7(0.0 to 8.9)
Fever: Moderate
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0021.7(0.0 to 8.9)
Fever: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Fever: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Vomiting: Any
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0011.6(0.0 to 8.8)
OG0020.0(0.0 to 6.0)
Vomiting: Mild
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0011.6(0.0 to 8.8)
OG0020.0(0.0 to 6.0)
Vomiting: Moderate
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Vomiting: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Vomiting: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Diarrhea: Any
Title
Measurements
OG0004.8(0.1 to 23.8)
OG00111.5(4.7 to 22.2)
OG00215.0(7.1 to 26.6)
Diarrhea: Mild
Title
Measurements
OG0004.8(0.1 to 23.8)
OG0018.2(2.7 to 18.1)
OG00211.7(4.8 to 22.6)
Diarrhea: Moderate
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0013.3(0.4 to 11.3)
OG0023.3(0.4 to 11.5)
Diarrhea: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Diarrhea: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Headache: Any
Title
Measurements
OG0009.5(1.2 to 30.4)
OG00113.1(5.8 to 24.2)
OG00215.0(7.1 to 26.6)
Headache: Mild
Title
Measurements
OG0000.0(0.0 to 16.1)
OG00113.1(5.8 to 24.2)
OG0028.3(2.8 to 18.4)
Headache: Moderate
Title
Measurements
OG0009.5(1.2 to 30.4)
OG0010.0(0.0 to 5.9)
OG0026.7(1.8 to 16.2)
Headache: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Headache: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Fatigue: Any
Title
Measurements
OG00019.0(5.4 to 41.9)
OG00126.2(15.8 to 39.1)
OG00226.7(16.1 to 39.7)
Fatigue: Mild
Title
Measurements
OG00014.3(3.0 to 36.3)
OG00118.0(9.4 to 30.0)
OG00213.3(5.9 to 24.6)
Fatigue: Moderate
Title
Measurements
OG0004.8(0.1 to 23.8)
OG0018.2(2.7 to 18.1)
OG00213.3(5.9 to 24.6)
Fatigue: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Fatigue: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
New/worsening muscle pain: Any
Title
Measurements
OG00019.0(5.4 to 41.9)
OG0014.9(1.0 to 13.7)
OG0028.3(2.8 to 18.4)
New/worsening muscle pain: Mild
Title
Measurements
OG0004.8(0.1 to 23.8)
OG0013.3(0.4 to 11.3)
OG0026.7(1.8 to 16.2)
New/worsening muscle pain: Moderate
Title
Measurements
OG00014.3(3.0 to 36.3)
OG0011.6(0.0 to 8.8)
OG0020.0(0.0 to 6.0)
New/worsening muscle pain: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0021.7(0.0 to 8.9)
New/worsening muscle pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
New/worsening joint pain: Any
Title
Measurements
OG0004.8(0.1 to 23.8)
OG0018.2(2.7 to 18.1)
OG0028.3(2.8 to 18.4)
New/worsening joint pain: Mild
Title
Measurements
OG0004.8(0.1 to 23.8)
OG0011.6(0.0 to 8.8)
OG0025.0(1.0 to 13.9)
New/worsening joint pain: Moderate
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0016.6(1.8 to 15.9)
OG0023.3(0.4 to 11.5)
New/worsening joint pain: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
New/worsening joint pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Any systemic event: Any
Title
Measurements
OG00023.8(8.2 to 47.2)
OG00132.8(21.3 to 46.0)
OG00245.0(32.1 to 58.4)
Any systemic event: Mild
Title
Measurements
OG0004.8(0.1 to 23.8)
OG00121.3(11.9 to 33.7)
OG00223.3(13.4 to 36.0)
Any systemic event: Moderate
Title
Measurements
OG00019.0(5.4 to 41.9)
OG00111.5(4.7 to 22.2)
OG00220.0(10.8 to 32.3)
Any systemic event: Severe
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0021.7(0.0 to 8.9)
Any systemic event: Grade 4
Title
Measurements
OG0000.0(0.0 to 16.1)
OG0010.0(0.0 to 5.9)
OG0020.0(0.0 to 6.0)
Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG002
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.
Units
Counts
Participants
OG00017
OG00153
OG00250
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0011.9(0.0 to 10.1)
OG0024.0(0.5 to 13.7)
Fever: Mild
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0022.0(0.1 to 10.6)
Fever: Moderate
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Fever: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0011.9(0.0 to 10.1)
OG0022.0(0.1 to 10.6)
Fever: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Vomiting: Any
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0011.9(0.0 to 10.1)
OG0022.0(0.1 to 10.6)
Vomiting: Mild
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0011.9(0.0 to 10.1)
OG0020.0(0.0 to 7.1)
Vomiting: Moderate
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0022.0(0.1 to 10.6)
Vomiting: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Vomiting: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Diarrhea: Any
Title
Measurements
OG00023.5(6.8 to 49.9)
OG00117.0(8.1 to 29.8)
OG00218.0(8.6 to 31.4)
Diarrhea: Mild
Title
Measurements
OG0005.9(0.1 to 28.7)
OG0017.5(2.1 to 18.2)
OG00216.0(7.2 to 29.1)
Diarrhea: Moderate
Title
Measurements
OG00017.6(3.8 to 43.4)
OG0019.4(3.1 to 20.7)
OG0020.0(0.0 to 7.1)
Diarrhea: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0022.0(0.1 to 10.6)
Diarrhea: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Headache: Any
Title
Measurements
OG00023.5(6.8 to 49.9)
OG00126.4(15.3 to 40.3)
OG00214.0(5.8 to 26.7)
Headache: Mild
Title
Measurements
OG00017.6(3.8 to 43.4)
OG00117.0(8.1 to 29.8)
OG00212.0(4.5 to 24.3)
Headache: Moderate
Title
Measurements
OG0005.9(0.1 to 28.7)
OG0019.4(3.1 to 20.7)
OG0022.0(0.1 to 10.6)
Headache: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Headache: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Fatigue: Any
Title
Measurements
OG00017.6(3.8 to 43.4)
OG00139.6(26.5 to 54.0)
OG00232.0(19.5 to 46.7)
Fatigue: Mild
Title
Measurements
OG00011.8(1.5 to 36.4)
OG00120.8(10.8 to 34.1)
OG00220.0(10.0 to 33.7)
Fatigue: Moderate
Title
Measurements
OG0005.9(0.1 to 28.7)
OG00118.9(9.4 to 32.0)
OG00212.0(4.5 to 24.3)
Fatigue: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Fatigue: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
New/worsening muscle pain: Any
Title
Measurements
OG00011.8(1.5 to 36.4)
OG00126.4(15.3 to 40.3)
OG00224.0(13.1 to 38.2)
New/worsening muscle pain: Mild
Title
Measurements
OG0000.0(0.0 to 19.5)
OG00117.0(8.1 to 29.8)
OG00214.0(5.8 to 26.7)
New/worsening muscle pain: Moderate
Title
Measurements
OG00011.8(1.5 to 36.4)
OG0019.4(3.1 to 20.7)
OG00210.0(3.3 to 21.8)
New/worsening muscle pain: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
New/worsening muscle pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
New/worsening joint pain: Any
Title
Measurements
OG00011.8(1.5 to 36.4)
OG00120.8(10.8 to 34.1)
OG00214.0(5.8 to 26.7)
New/worsening joint pain: Mild
Title
Measurements
OG0000.0(0.0 to 19.5)
OG00113.2(5.5 to 25.3)
OG00210.0(3.3 to 21.8)
New/worsening joint pain: Moderate
Title
Measurements
OG00011.8(1.5 to 36.4)
OG0017.5(2.1 to 18.2)
OG0024.0(0.5 to 13.7)
New/worsening joint pain: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
New/worsening joint pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Any systemic event: Any
Title
Measurements
OG00035.3(14.2 to 61.7)
OG00150.9(36.8 to 64.9)
OG00258.0(43.2 to 71.8)
Any systemic event: Mild
Title
Measurements
OG0005.9(0.1 to 28.7)
OG00117.0(8.1 to 29.8)
OG00234.0(21.2 to 48.8)
Any systemic event: Moderate
Title
Measurements
OG00029.4(10.3 to 56.0)
OG00132.1(19.9 to 46.3)
OG00220.0(10.0 to 33.7)
Any systemic event: Severe
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0011.9(0.0 to 10.1)
OG0024.0(0.5 to 13.7)
Any systemic event: Grade 4
Title
Measurements
OG0000.0(0.0 to 19.5)
OG0010.0(0.0 to 6.7)
OG0020.0(0.0 to 7.1)
Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
OG002
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.
Units
Counts
Participants
OG0004
OG00112
OG00212
Title
Denominators
Categories
Fever: Any
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Fever: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Fever: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Fever: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Fever: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Vomiting: Any
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Vomiting: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Vomiting: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Vomiting: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Vomiting: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Diarrhea: Any
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Diarrhea: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Diarrhea: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Diarrhea: Severe
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Diarrhea: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Headache: Any
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0018.3(0.2 to 38.5)
OG0028.3(0.2 to 38.5)
Headache: Mild
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010.0(0.0 to 26.5)
OG0028.3(0.2 to 38.5)
Headache: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0018.3(0.2 to 38.5)
OG0020.0(0.0 to 26.5)
Headache: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Headache: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Fatigue: Any
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00133.3(9.9 to 65.1)
OG0028.3(0.2 to 38.5)
Fatigue: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00125.0(5.5 to 57.2)
OG0028.3(0.2 to 38.5)
Fatigue: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0018.3(0.2 to 38.5)
OG0020.0(0.0 to 26.5)
Fatigue: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Fatigue: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
New/worsening muscle pain: Any
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00116.7(2.1 to 48.4)
OG0020.0(0.0 to 26.5)
New/worsening muscle pain: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0018.3(0.2 to 38.5)
OG0020.0(0.0 to 26.5)
New/worsening muscle pain: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0018.3(0.2 to 38.5)
OG0020.0(0.0 to 26.5)
New/worsening muscle pain: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
New/worsening muscle pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
New/worsening joint pain: Any
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00125.0(5.5 to 57.2)
OG0020.0(0.0 to 26.5)
New/worsening joint pain: Mild
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0018.3(0.2 to 38.5)
OG0020.0(0.0 to 26.5)
New/worsening joint pain: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00116.7(2.1 to 48.4)
OG0020.0(0.0 to 26.5)
New/worsening joint pain: Severe
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
New/worsening joint pain: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Any systemic event: Any
Title
Measurements
OG00050.0(6.8 to 93.2)
OG00150.0(21.1 to 78.9)
OG0028.3(0.2 to 38.5)
Any systemic event: Mild
Title
Measurements
OG00025.0(0.6 to 80.6)
OG00125.0(5.5 to 57.2)
OG0028.3(0.2 to 38.5)
Any systemic event: Moderate
Title
Measurements
OG0000.0(0.0 to 60.2)
OG00125.0(5.5 to 57.2)
OG0020.0(0.0 to 26.5)
Any systemic event: Severe
Title
Measurements
OG00025.0(0.6 to 80.6)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Any systemic event: Grade 4
Title
Measurements
OG0000.0(0.0 to 60.2)
OG0010.0(0.0 to 26.5)
OG0020.0(0.0 to 26.5)
Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.