Dose Escalating Study of a Prototype CS6 Subunit Vaccine... | NCT03404674 | Trialant
NCT03404674
Sponsor
PATH
Status
Completed
Last Update Posted
Jan 6, 2021Actual
Enrollment
50Actual
Phase
Phase 1
Conditions
Diarrhea
Interventions
CssBA
dmLT
Countries
United States
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT03404674
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
VAC-050
Secondary IDs
Not provided
Brief Title
Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)
Official Title
A Phase 1 Dose Escalating Study of a Prototype CS6 Subunit Vaccine With a Modified Heat-labile Enterotoxin From Enterotoxigenic Escherichia Coli (ETEC)
Acronym
Not provided
Organization
PATHOTHER
Status Module
Record Verification Date
Nov 2020
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
Jan 16, 2018Actual
Primary Completion Date
Mar 26, 2019Actual
Completion Date
Mar 26, 2019Actual
First Submitted Date
Jan 10, 2018
First Submission Date that Met QC Criteria
Jan 18, 2018
First Posted Date
Jan 19, 2018Actual
Results Waived
Not provided
Results First Submitted Date
Dec 10, 2020
Results First Submitted that Met QC Criteria
Dec 10, 2020
Results First Posted Date
Jan 6, 2021Actual
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 10, 2020
Last Update Posted Date
Jan 6, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PATHOTHER
Collaborators
Name
Class
Naval Medical Research Center
FED
Walter Reed Army Institute of Research (WRAIR)
FED
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
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 evaluate the safety of a prototype Coli surface antigen 6 (CS6) subunit vaccine (CssBA) alone or in combination with Escherichia coli double mutant heat labile toxin (dmLT) given by intramuscular (IM) injection.
Detailed Description
This is an open-label clinical trial in which a total of 50 participants will receive three injections of either CssBA alone, dmLT alone or CssBA + dmLT. The vaccine will be administered via IM injection to alternating deltoid regions on days 1, 22, and 43. Each participant will receive the same dose at each vaccination dependent upon group assignment. Group A is considered a pilot group in which all 3 doses will be administered and participants monitored for safety 7 days after the third vaccination, prior to the enrollment of participants in Group B.
Conditions Module
Conditions
Diarrhea
Keywords
ETEC
Escherichia coli
enteric
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 1
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
50Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Group A1: CssBA 5 ug
Experimental
Participants received an intramuscular injection of 5 ug CssBA on days 1, 22, and 43.
Biological: CssBA
Group A2: DmLT 100 ng
Experimental
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
Biological: dmLT
Group B: CssBA 5 ug + DmLT 100 ng
Experimental
Participants received an intramuscular injection of 5 ug CssBA + 100 ng dmLT on days 1, 22, and 43.
Biological: CssBA
Biological: dmLT
Group C: CssBA 5 ug + DmLT 500 ng
Experimental
Participants received an intramuscular injection of 5 ug CssBA + 500 ng dmLT on days 1, 22, and 43.
Biological: CssBA
Biological: dmLT
Group D: CssBA 15 ug + DmLT 500 ng
Experimental
Participants received an intramuscular injection of 15 ug CssBA + 500 ng dmLT on days 1, 22, and 43.
Biological: CssBA
Biological: dmLT
Interventions
Name
Type
Description
Arm Group Labels
Other Names
CssBA
Biological
Recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 containing modified structural subunits A and B
Group A1: CssBA 5 ug
Group B: CssBA 5 ug + DmLT 100 ng
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants With Solicited Adverse Events
Solicited adverse events included vaccine site pain, vaccine site pruritus, vaccine site rash/eruption, vaccine site swelling, vaccine site tenderness, fever, headache, diarrhea, arthralgia, myalgia, malaise, nausea, and vomiting.
Adverse events were assessed for severity by the investigator according to the following:
Mild (Grade 1): Does not interfere with routine activities, minimal level of discomfort
Moderate (Grade 2): Interferes with routine activities, moderate level of discomfort
Severe (Grade 3): Unable to perform routine activities, significant level of discomfort
Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
From first vaccination to 28 days after the third vaccination, 71 days.
Number of Participants With Unsolicited Adverse Events
Adverse events were assessed for severity by the investigator according to the following:
Mild (Grade 1): Does not interfere with routine activities Minimal level of discomfort
Moderate (Grade 2): Interferes with routine activities Moderate level of discomfort
Severe (Grade 3): Unable to perform routine activities Significant level of discomfort
Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
From first vaccination to 28 days after the third vaccination, 71 days.
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6)
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Healthy, adult, male or female, age 18 to 45 years (inclusive) at the time of enrollment.
Completion and review of comprehension test (achieved > 70% accuracy).
Signed informed consent document.
Available for the required follow-up period and scheduled clinic visits.
Women: Negative pregnancy test with understanding (through informed consent process) to not become pregnant during the study or within three (3) months following last vaccination.
Exclusion Criteria:
Health problems (for example, intercurrent febrile illness, chronic medical conditions such as psychiatric conditions, diabetes mellitus, hypertension or any other condition that might place the subject at increased risk of adverse events) - study clinicians, in consultation with the PI, will use clinical judgment on a case-by-case basis to assess safety risks under this criterion. The PI will consult with the Research Monitor as appropriate.
Clinically significant abnormalities on physical examination.
Immunosuppressive drugs (use of systemic corticosteroids or chemotherapeutics that may influence antibody development) or illness (including immunoglobulin A [IgA] deficiency, defined by serum IgA < 7 mg/dL).
Women who are pregnant or planning to become pregnant during the study period plus three (3) months beyond the last received dose and currently nursing women.
Participation in research involving another investigational product (defined as receipt of investigational product or exposure to invasive investigational device) 30 days before planned date of first vaccination or anytime through the last study safety visit.
Positive blood test for Hepatitis B surface antigen (HBsAg), Hepatitis C virus (HCV), human immunodeficiency virus (HIV)-1/2.
Clinically significant abnormalities on basic laboratory screening.
Exclusionary skin disease history/findings that would confound assessment or prevent appropriate local monitoring of adverse events (AEs), or possibly increase the risk of a local AE
History of chronic skin disease (clinician judgement)
Acute skin infection/eruptions on the upper arms including fungal infections, severe acne or active contact dermatitis
Allergies that may increase the risk of AEs
Regular use (weekly or more often) of antidiarrheal, anti-constipation, or antacid therapy
Abnormal stool pattern (fewer than 3 stools per week or more than 3 stools per day) on a regular basis; loose or liquid stools on other than an occasional basis
History of microbiologically confirmed ETEC or cholera infection in the last 3 years
Travel to countries where ETEC or V. cholerae or other enteric infections are endemic (most of the developing world) within 3 years prior to dosing (clinician judgement)
Symptoms consistent with Travelers' Diarrhea or concurrent with travel to countries where ETEC infection is endemic (most of the developing world) within 3 years prior to dosing, OR planned travel to endemic countries during the length of the study
Vaccination for or ingestion of ETEC, cholera, or E. coli heat labile toxin within 3 years prior to dosing
Occupation involving handling of ETEC or V. cholerae currently, or in the past 3 years
Accepts Healthy Volunteers
Yes
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
45 Years
Standard Ages
Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Tida K Lee, MD, PhD
Naval Medical Research Center
Principal Investigator
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Walter Reed Army Institute of Research Clinical Trial Center
Silver Spring
Maryland
20910
United States
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
No data available
No data is available for this block.
Participants were sequentially enrolled to received either recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 vaccine (CssBA) alone, Escherichia coli double mutant heat-labile toxin (dmLT) alone, or CssBA co-administered with dmLT. Participants were to receive 3 vaccinations at the same dose of their assigned treatment.
Enrollment of subsequent groups was dependent on safety measured in the first 7 days after the third vaccination of the previous group.
Recruitment Details
Healthy adult men and women, civilian and active-duty military, were recruited from the Baltimore/Washington, DC area through the Walter Reed Army Institute of Research (WRAIR) Clinical Trials Center (CTC) by the use of advertisement in multiple media formats.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
FG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
FG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
FG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
FG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
FG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Enrolled and received Dose 1
FG0005 subjects
FG0015 subjects
FG00210 subjects
FG00310 subjects
FG004
Received Dose 2
FG0005 subjects
FG0014 subjects
FG00210 subjects
FG0039 subjects
FG004
Received Dose 3
FG0005 subjects
FG0014 subjects
FG0029 subjects
FG0039 subjects
FG004
COMPLETED
FG0005 subjects
FG0014 subjects
FG0028 subjects
FG0039 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Inability to Attend Future Visits
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
All enrolled participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
BG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Median
Outcome Measures Module
Outcome Measures
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
Number of Participants With Solicited Adverse Events
Solicited adverse events included vaccine site pain, vaccine site pruritus, vaccine site rash/eruption, vaccine site swelling, vaccine site tenderness, fever, headache, diarrhea, arthralgia, myalgia, malaise, nausea, and vomiting.
Adverse events were assessed for severity by the investigator according to the following:
Mild (Grade 1): Does not interfere with routine activities, minimal level of discomfort
Moderate (Grade 2): Interferes with routine activities, moderate level of discomfort
Severe (Grade 3): Unable to perform routine activities, significant level of discomfort
Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
All participants who received one or more doses of the study drugs
Posted
Count of Participants
Participants
From first vaccination to 28 days after the third vaccination, 71 days.
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Adverse Events Module
Frequency Threshold
0
Time Frame
From the day of the first vaccination up to 28 days after the third vaccination, 71 days.
Description
Not provided
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
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
Participants received an intramuscular injection of 45 ug CssBA + 500 ng dmLT on days 1, 22, and 43.
Biological: CssBA
Biological: dmLT
Group C: CssBA 5 ug + DmLT 500 ng
Group D: CssBA 15 ug + DmLT 500 ng
Group E: CssBA 45 ug + DmLT 500 ng
spd_dsc16Bntd14CssBAB7A[His]₆
dmLT
Biological
Escherichia coli double mutant heat-labile toxin with mutations at amino acids 192 and 211
Group A2: DmLT 100 ng
Group B: CssBA 5 ug + DmLT 100 ng
Group C: CssBA 5 ug + DmLT 500 ng
Group D: CssBA 15 ug + DmLT 500 ng
Group E: CssBA 45 ug + DmLT 500 ng
Percentage of Participants With a Serum Immunologic Response to Labile Toxin
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6)
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against CS6 at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA.
A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against labile toxin at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA.
A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Days 1, 22, and 43 pre-vaccination, and Day 70
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against CS6 using ELISA.
Days 1, 8, 29 and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against CS6 using ELISA.
Days 1, 8, 29, and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against labile toxin using ELISA.
Days 1, 8, 29, and 50
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against labile toxin using ELISA.
Days 1, 8, 29, and 50
10 subjects
FG00510 subjects
10 subjects
FG00510 subjects
10 subjects
FG0059 subjects
10 subjects
FG0059 subjects
0 subjects
FG0051 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Behavioral Problems
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Started a Medication that Precluded Eligibility
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
BG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
BG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
BG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
BG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
BG006
Total
Total of all reporting groups
5
BG0015
BG00210
BG00310
BG00410
BG00510
BG00650
Inter-Quartile Range
years
Title
Denominators
Categories
Title
Measurements
BG00032(30 to 41)
BG00129(27 to 37)
BG00229.5(26 to 32)
BG00331.5(27 to 37)
BG00428(22 to 38)
BG00529.5(25 to 33)
BG00630(26 to 37)
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0012
BG0025
BG0037
BG0045
BG0057
BG00630
Male
BG0001
BG0013
BG0025
BG0033
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0012
BG0021
BG0030
BG0042
BG0051
BG0066
Not Hispanic or Latino
BG0005
BG0013
BG0029
BG00310
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Asian
BG0000
BG0010
BG0020
BG0032
BG0040
BG0050
BG0062
Black
BG0004
BG0014
BG0023
BG0035
BG004
White
BG0001
BG0011
BG0027
BG0033
BG004
Multi-race
BG0000
BG0010
BG0020
BG0030
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG0005
BG0015
BG00210
BG00310
BG00410
BG00510
BG00610
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0015
OG00210
OG00310
OG00410
OG00510
Title
Denominators
Categories
Mild
Title
Measurements
OG0002
OG0015
OG0029
OG0039
OG00410
OG00510
Moderate
Title
Measurements
OG0000
OG0010
OG0022
OG003
Severe
Title
Measurements
OG0000
OG0010
OG0020
OG003
Life-threatening
Title
Measurements
OG0000
OG0010
OG0020
OG003
Secondary
Percentage of Participants With a Serum Immunologic Response to Coli Surface Antigen 6 (CS6)
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
Posted
Number
percentage of participants
Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
IgA response
Title
Measurements
OG0000.0
OG0010.0
OG0020.0
OG003
Secondary
Percentage of Participants With a Serum Immunologic Response to Labile Toxin
Serum samples were assayed for immunoglobulin G (IgG) and immunoglobulin A (IgA) antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA). Immunologic response was defined as a ≥ 4-fold increase in reciprocal endpoint titer between Baseline and any post-vaccination sample.
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
Posted
Number
percentage of participants
Baseline (Day 1 predose), Days 22 and 43 predose, and Day 70
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
IgA response
Title
Measurements
OG0000.0
OG00150.0
OG00222.2
OG003
Secondary
Percentage of Participants With a Mucosal Immunologic Response to Coli Surface Antigen 6 (CS6)
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against CS6 at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA.
A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
Posted
Number
percentage of participants
Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
IgA response
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG003
Secondary
Percentage of Participants With a Mucosal Immunologic Response to Labile Toxin
Peripheral blood mononuclear cells (PBMCs) were collected to determine antibody responses from lymphocyte supernatant against labile toxin at Baseline and 7 days after each vaccination. Antibody in lymphocyte supernatant (ALS) is an indirect quantification of antibody secreting cells (ASC) activated in the mucosa that circulate in the peripheral blood about seven days post-mucosal immunization/infection. After incubation, lymphocyte supernatant was assayed for antigen-specific IgG and IgA antibodies using ELISA.
A positive ALS response was defined as a four-fold rise in antibody titers between Baseline and any post vaccination sample.
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available.
Posted
Number
percentage of participants
Baseline (Day 1 pre-dose), Days 8 and 29 predose, and Day 50
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
IgA response
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG003
Secondary
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 22, and 43 pre-vaccination, and Day 70
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
Day 1 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG003
Secondary
Geometric Mean Titer of Serum Anti-CS6 Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against CS6 using an enzyme-linked Immunosorbent assay (ELISA).
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 22, and 43 pre-vaccination, and Day 70
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
Day 1 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG003
Primary
Number of Participants With Unsolicited Adverse Events
Adverse events were assessed for severity by the investigator according to the following:
Mild (Grade 1): Does not interfere with routine activities Minimal level of discomfort
Moderate (Grade 2): Interferes with routine activities Moderate level of discomfort
Severe (Grade 3): Unable to perform routine activities Significant level of discomfort
Potentially life-threatening (Grade 4): Hospitalization or emergency room (ER) visit for potentially life-threatening event
All participants who received one or more doses of the study drugs
Posted
Count of Participants
Participants
From first vaccination to 28 days after the third vaccination, 71 days.
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0015
OG00210
OG003
Title
Denominators
Categories
Mild
Title
Measurements
OG0004
OG0013
OG0025
OG003
Secondary
Geometric Mean Titer of Serum Anti-LT Immunoglobulin G Antibodies
Serum samples were assayed for IgG antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 22, and 43 pre-vaccination, and Day 70
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
Day 1 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG003
Secondary
Geometric Mean Titer of Serum Anti-LT Immunoglobulin A Antibodies
Serum samples were assayed for IgA antibody titers against labile toxin using an enzyme-linked Immunosorbent assay (ELISA).
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 22, and 43 pre-vaccination, and Day 70
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
Day 1 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG003
Secondary
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against CS6 using ELISA.
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 8, 29 and 50
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0028
OG003
Title
Denominators
Categories
Day 1 (pre-vaccination)
Title
Measurements
OG0004.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0014.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG002
Secondary
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-CS6 Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against CS6 using ELISA.
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 8, 29, and 50
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
Day 1 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG003
Secondary
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin G Antibodies
Lymphocyte supernatant was assayed for IgG antibody titers against labile toxin using ELISA.
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available data at each time point.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 8, 29, and 50
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received 3 intramuscular injections of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0028
OG003
Title
Denominators
Categories
Day 1 (pre-vaccination)
Title
Measurements
OG0002.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0012.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG002
Secondary
Geometric Mean Titer of Antibody Lymphocyte Supernatant Anti-LT Immunoglobulin A Antibodies
Lymphocyte supernatant was assayed for IgA antibody titers against labile toxin using ELISA.
Participants who received at least 2 vaccine doses and had at least 2 post-vaccine samples available, and with available samples at each time point.
Posted
Geometric Mean
95% Confidence Interval
titer
Days 1, 8, 29, and 50
ID
Title
Description
OG000
Group A1: CssBA 5 µg
Participants received an intramuscular injection of 5 µg CssBA on days 1, 22, and 43.
OG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
OG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
OG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
OG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
Units
Counts
Participants
OG0005
OG0014
OG0029
OG003
Title
Denominators
Categories
Day 1 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG003
0
5
0
5
4
5
EG001
Group A2: DmLT 100 ng
Participants received an intramuscular injection of 100 ng DmLT on days 1, 22, and 43.
0
5
0
5
5
5
EG002
Group B: CssBA 5 µg + DmLT 100 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 100 ng dmLT on days 1, 22, and 43.
0
10
0
10
10
10
EG003
Group C: CssBA 5 µg + DmLT 500 ng
Participants received an intramuscular injection of 5 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
0
10
0
10
10
10
EG004
Group D: CssBA 15 µg + DmLT 500 ng
Participants received an intramuscular injection of 15 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
0
10
0
10
10
10
EG005
Group E: CssBA 45 µg + DmLT 500 ng
Participants received an intramuscular injection of 45 µg CssBA co-administered with 500 ng dmLT on days 1, 22, and 43.
0
10
0
10
10
10
EG0003 affected5 at risk
EG0011 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0042 affected10 at risk
EG0050 affected10 at risk
Leukocytosis
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0031 affected10 at risk
EG0041 affected10 at risk
EG0051 affected10 at risk
Leukopenia
Blood and lymphatic system disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Bradycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Tachycardia
Cardiac disorders
MedDRA
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0031 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Conjunctivital hemorrhage
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Eye pruritus
Eye disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Abdominal Pain
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Constipation
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0022 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Hemorroidal hemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0031 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Axillary Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Chills
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Fatigue
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Hangover
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Injection Site Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Vaccination Site Bruising
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0031 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Vessel Puncture Site Hematoma
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Vessel Puncture Site Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Hypersensitivity
Immune system disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Folliculitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Pharyngitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Upper Respiratory Tract Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0031 affected10 at risk
EG0042 affected10 at risk
EG0056 affected10 at risk
Vaginal Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Viral Upper Respiratory Tract Infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Concussion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Contusion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Lower Limb Fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Skin Abrasion
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Aspartate aminotransferase increased
Investigations
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0021 affected10 at risk
EG0031 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Hemoglobin decreased
Investigations
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0032 affected10 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
Neutrophil Count Decreased
Investigations
MedDRA
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Hypercalcemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Hyperglycemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Hyperkalemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0030 affected10 at risk
EG0043 affected10 at risk
EG0054 affected10 at risk
Hypoglycemia
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Vitamin D Deficiency
Metabolism and nutrition disorders
MedDRA
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Muscle Spasms
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Musculoskeletal Pain
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Dizziness
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0031 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0031 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Nasal Congestion
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0042 affected10 at risk
EG0050 affected10 at risk
Rhinorrhea
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Diastolic Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Systolic Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0002 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0052 affected10 at risk
Diarrhea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0023 affected10 at risk
EG0033 affected10 at risk
EG0043 affected10 at risk
EG0053 affected10 at risk
Nausea
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0021 affected10 at risk
EG0031 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Vomiting
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0031 affected10 at risk
EG0040 affected10 at risk
EG0050 affected10 at risk
Malaise
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0023 affected10 at risk
EG0030 affected10 at risk
EG0043 affected10 at risk
EG0052 affected10 at risk
Pyrexia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0042 affected10 at risk
EG0050 affected10 at risk
Vaccination Site Pain
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0011 affected5 at risk
EG0022 affected10 at risk
EG0035 affected10 at risk
EG0049 affected10 at risk
EG0059 affected10 at risk
Vaccination Site Pruritus
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0021 affected10 at risk
EG0031 affected10 at risk
EG0047 affected10 at risk
EG0050 affected10 at risk
Vaccination Site Discoloration
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Vaccination Site Erythema
General disorders
MedDRA
Systematic Assessment
EG0001 affected5 at risk
EG0014 affected5 at risk
EG0027 affected10 at risk
EG0037 affected10 at risk
EG0048 affected10 at risk
EG0058 affected10 at risk
Vaccination Site Induration
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0036 affected10 at risk
EG0045 affected10 at risk
EG0056 affected10 at risk
Vaccination Site Papule
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0040 affected10 at risk
EG0051 affected10 at risk
Vaccination Site Swelling
General disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0031 affected10 at risk
EG0041 affected10 at risk
EG0050 affected10 at risk
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0030 affected10 at risk
EG0042 affected10 at risk
EG0051 affected10 at risk
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0020 affected10 at risk
EG0031 affected10 at risk
EG0042 affected10 at risk
EG0054 affected10 at risk
Headache
Nervous system disorders
MedDRA
Systematic Assessment
EG0001 affected5 at risk
EG0010 affected5 at risk
EG0026 affected10 at risk
EG0032 affected10 at risk
EG0043 affected10 at risk
EG0052 affected10 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D016905
Gram-Negative Bacterial Infections
D001424
Bacterial Infections
D001423
Bacterial Infections and Mycoses
D007239
Infections
5
BG0053
BG00620
8
BG0059
BG00644
0
BG0050
BG0060
3
BG0054
BG00623
7
BG0055
BG00624
0
BG0051
BG0061
1
OG0042
OG0052
0
OG0041
OG0050
0
OG0040
OG0050
9
OG00410
OG00510
44.4
OG00430.0
OG00550.0
IgG response
Title
Measurements
OG00020.0
OG0010.0
OG00277.8
OG003100.0
OG004100.0
OG00590.0
9
OG00410
OG00510
77.8
OG00450.0
OG00570.0
IgG response
Title
Measurements
OG0000.0
OG001100.0
OG00266.7
OG003100.0
OG00490.0
OG005100.0
9
OG00410
OG00510
9
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0000.0
OG0010.0
OG00233.3
OG00388.9
OG00480.0
OG005100.0
IgG response
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00060.0
OG0010.0
OG002100.0
OG003
9
OG00410
OG00510
9
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0000.0
OG001100.0
OG00222.2
OG00377.8
OG00490.0
OG005100.0
IgG response
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0000.0
OG001100.0
OG002100.0
OG003
9
OG00410
OG00510
9
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00039.0(18.2 to 83.6)
OG00129.6(17.5 to 50.1)
OG00239.1(22.2 to 69.1)
OG00336.9(20.5 to 66.6)
OG00440.5(24.6 to 66.7)
OG00551.5(26.1 to 101.4)
Day 22 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00040.2(17.8 to 90.8)
OG00134.1(12.9 to 90.7)
OG00228.2(21.6 to 36.8)
OG003
Day 43 (pre-vacination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00057.4(16.9 to 195)
OG00146.6(14.5 to 149.8)
OG002108.9(54.3 to 218.4)
OG003
Day 70 (28 days after last vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00081.3(19.0 to 346.7)
OG00129.4(17.8 to 48.5)
OG002695.3(182.1 to 2655.3)
OG003
9
OG00410
OG00510
9
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG000269.9(133.6 to 545.1)
OG001213.4(73.0 to 623.6)
OG002308.5(181.4 to 524.4)
OG003330.0(176.1 to 618.6)
OG004368.2(192.3 to 705.0)
OG005370.8(180.9 to 760.0)
Day 22 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG000294.3(128.7 to 672.9)
OG001215(64.9 to 712.4)
OG002285.1(172.9 to 469.9)
OG003
Day 43 (pre-vacination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG000260.9(122.0 to 557.8)
OG001164.7(47.5 to 571.3)
OG002328.7(200.5 to 538.8)
OG003
Day 70 (28 days after last vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG000339.1(143.6 to 800.6)
OG001218.0(48.4 to 982.4)
OG002521.6(236.5 to 1150.3)
OG003
10
OG00410
OG00510
6
OG00410
OG0059
Moderate
Title
Measurements
OG0002
OG0010
OG0022
OG0030
OG0041
OG0053
Severe
Title
Measurements
OG0001
OG0010
OG0021
OG0030
OG0041
OG0052
Life-threatening
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
9
OG00410
OG00510
9
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00046.1(16.4 to 129.7)
OG00125.1(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00284.5(31.8 to 224.0)
OG00388.9(54.0 to 146.5)
OG00475.0(37.4 to 150.4)
OG00548.8(25.0 to 95.2)
Day 22 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00048.3(15.3 to 152.1)
OG00152.8(11.4 to 243.9)
OG002172.9(42.4 to 705.5)
OG003
Day 43 (pre-vacination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00046.3(15.8 to 136.0)
OG001303.7(39.8 to 2316.2)
OG002235.6(67.5 to 822.0)
OG003
Day 70 (28 days after last vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00055.0(17.8 to 170.1)
OG001398.1(91.9 to 1724.3)
OG002424.1(159.7 to 1126.6)
OG003
9
OG00410
OG00510
9
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00025.1(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00125.1(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00228.4(21.4 to 37.7)
OG00325.8(24.2 to 27.6)
OG00428.6(21.3 to 38.5)
OG00525.1(NA to NA)Confidence interval could not be calculated as the variance was zero
Day 22 (pre-vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00025.1(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00130.4(16.6 to 55.6)
OG00255.8(24.6 to 126.5)
OG003
Day 43 (pre-vacination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00025.1(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00146.2(9.0 to 238.30)
OG00248.5(22.0 to 107.0)
OG003
Day 70 (28 days after last vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG00025.1(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00166.1(10.6 to 410.1)
OG00251.4(20.9 to 126.4)
OG003
9
OG00410
OG00510
4.0
(NA to NA)
Confidence interval could not be calculated as the variance was zero
OG0035.7(2.5 to 12.8)
OG0044.(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0054.0(NA to NA)Confidence interval could not be calculated as the variance was zero
Day 8 (7 days after 1st vaccination)
Title
Measurements
OG0004.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0014.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0025.0(2.9 to 8.6)
OG00314.9(3.2 to 70.3)
OG0048.5(2.7 to 26.6)
OG0057.1(3.0 to 17.0)
Day 29 (7 days after 2nd vacination)
Title
Measurements
OG0006.0(2.0 to 18.4)
OG0014.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0024.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00342.9(10.7 to 172.0)
OG00429.8(8.2 to 108.6)
OG00547.4(12.7 to 176.5)
Day 50 (7 days after 3rd vaccination)
Title
Measurements
OG00018.1(3.1 to 106.4)
OG0014.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00286.7(43.1 to 174.4)
OG003356.9(208.5 to 610.7)
OG004238.3(115.3 to 492.3)
OG005142.8(32.2 to 633.2)
9
OG00410
OG00510
9
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0002.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0012.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0022.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0032.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0042.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0052.5(2.5 to 2.5)
Day 8 (7 days after 1st vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0002.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0012.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0022.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG003
Day 29 (7 days after 2nd vacination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0002.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0012.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0022.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG003
Day 50 (7 days after 3rd vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0002.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0012.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0026.4(2.1 to 19.6)
OG003
9
OG00410
OG00510
3.5
(1.6 to 7.8)
OG0032.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0043.1(2.0 to 4.8)
OG0052.5(NA to NA)Confidence interval could not be calculated as the variance was zero
Day 8 (7 days after 1st vaccination)
Title
Measurements
OG0002.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0012.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0026.6(1.5 to 29.2)
OG00324.0(6.0 to 97.0)
OG00447.4(8.7 to 258.8)
OG00517.6(5.0 to 61.4)
Day 29 (7 days after 2nd vacination)
Title
Measurements
OG0002.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00113.4(0.6 to 305.9)
OG00210.0(2.0 to 49.9)
OG003105.8(60.7 to 184.3)
OG00480.7(50.2 to 129.9)
OG005253.5(116.5 to 551.8)
Day 50 (7 days after 3rd vaccination)
Title
Measurements
OG0002.5(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00188.1(48.2 to 161.0)
OG00270.0(41.5 to 117.9)
OG003138.4(102.0 to 187.7)
OG004123.3(100.0 to 152.0)
OG005187.5(101.9 to 345.0)
9
OG00410
OG00510
9
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0002.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0012.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0022.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0032.8(1.3 to 5.9)
OG0042.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0052.0(NA to NA)Confidence interval could not be calculated as the variance was zero
Day 8 (7 days after 1st vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0002.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0012.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0023.0(1.1 to 8.1)
OG003
Day 29 (7 days after 2nd vacination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0029
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0002.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG0019.9(0.5 to 198.1)
OG0024.1(1.4 to 12.4)
OG003
Day 50 (7 days after 3rd vaccination)
ParticipantsOG0005
ParticipantsOG0014
ParticipantsOG0028
ParticipantsOG0039
ParticipantsOG00410
ParticipantsOG00510
Title
Measurements
OG0002.0(NA to NA)Confidence interval could not be calculated as the variance was zero
OG00113.3(1.6 to 107.6)
OG0023.6(1.4 to 9.5)
OG003
88.9
OG004100.0
OG00580.0
100.0
OG004100.0
OG005100.0
81.2
(16.6 to 396.6)
OG00480.1(39.4 to 162.9)
OG005107.1(28.3 to 405.7)
513.5
(77.2 to 3415.4)
OG004288.2(100.2 to 829.2)
OG005958.3(235.9 to 3893.4)
4631.2
(1462.3 to 14667.6)
OG0042520.4(1199.2 to 5297.2)
OG0055167.1(1298.8 to 20556.8)
846.9
(189.1 to 3792.6)
OG004408.0(223.1 to 746.1)
OG005523.5(262.0 to 1045.9)
1571.0
(341.7 to 7222.1)
OG004505.2(275.8 to 925.4)
OG0051188.9(515.4 to 2742.6)
2483.1
(595.3 to 10357.2)
OG004970.3(553.4 to 1701.4)
OG0052170.4(1053.0 to 4473.7)
1010.3
(182.9 to 5579.8)
OG004235.0(64.1 to 860.7)
OG005193.2(80.0 to 466.6)
2671.0
(754.2 to 9459.1)
OG004679.2(256.7 to 1797.0)
OG005666.8(339.7 to 1308.9)
3114.1
(965.3 to 10046.6)
OG0041116.9(467.8 to 2666.7)
OG0051086.4(473.8 to 2491.2)
258.4
(49.3 to 1352.9)
OG00477.8(35.3 to 171.3)
OG005134.6(57.0 to 317.6)
317.9
(72.8 to 1388.5)
OG00475.9(33.6 to 171.4)
OG005159.6(62.8 to 405.3)
202.1
(43.8 to 932.2)
OG00468.2(29.9 to 155.6)
OG005121.1(57.2 to 256.1)
7.3
(1.3 to 42.2)
OG0042.5(NA to NA)Confidence interval could not be calculated as the variance was zero