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This study will investigate a Clostridium difficile vaccine in adults 50 years of age and older. In half the adults, all 3 doses given are the Clostridium difficile vaccine, and in half the adults, 2 of the 3 doses are the Clostridium difficile vaccine with the other dose containing no active ingredients. The study will look at the subjects' immune response to the vaccine and assess the safety and tolerability of a 2-dose regimen of Clostridium difficile vaccine compared to a 3-dose regimen of Clostridium difficile vaccine.
Serology for B5091019 will be forthcoming. There have been delays due to discussions with the FDA on statistical analysis as well as delays attributable to the COVID pandemic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clostridium difficile vaccine - 3 dose | Experimental | All 3 doses are the Clostridium difficile vaccine |
|
| Clostridium difficile vaccine - 2 dose | Experimental | 2 of the 3 doses are the Clostridium difficile vaccine with the other being placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clostridium difficile | Biological | Toxoid-based Clostridium difficile vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Geometric Mean Concentration (GMC) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 for Evaluable Immunogenicity Population (EIP) | Adjusted GMCs and 2-sided 95% confidence intervals (CIs) of toxin A and toxin B specific neutralizing antibody levels were calculated by exponentiating the least square (LS) means and the corresponding CIs based on analysis of logarithmically transformed concentrations using a linear regression model with terms of baseline concentration (log scale) and vaccine group. EIP at Month 7 (EI7): all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 28 to 47 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 7; had no major protocol deviations. | Month 7 |
| Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 7 for EIP | Seroresponse was defined as at least a 4-fold rise from the baseline neutralizing antibody level following vaccination. 95% CI was based on Clopper-Pearson method. EI7: all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 28 to 47 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 7; had no major protocol deviations. | Month 7 |
| Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1 | Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 centimeter (cm). Redness and swelling were graded as mild: 2.5-5.0 cm, moderate: greater than (>) 5.0-10.0 cm, severe: >10.0 cm, potentially life threatening: necrosis or exfoliative dermatitis for redness, or necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, potentially life threatening: emergency room visit or hospitalization. The maximum severity was defined as highest grading of each local reaction through 7 days of vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Adjusted Geometric Mean Concentration for Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibody at Month 12 for EIP | Adjusted GMCs and 2-sided 95% CIs of toxin A and toxin B specific neutralizing antibody levels were calculated by exponentiating the LS means and the corresponding CIs based on analysis of logarithmically transformed concentrations using a linear regression model with terms of baseline concentration (log scale) and vaccine group. EI12: all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 165 to 200 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 12; had no major protocol deviations. |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP); and WOCBP who are, in the opinion of the investigator, sexually active and at risk for pregnancy and are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent until at least 28 days after the last dose of investigational product.
Prior episode of CDI, confirmed by either laboratory test or diagnosis of pseudomembranous colitis at colonoscopy, at surgery, or histopathologically.
Participants who may be unable to respond to vaccination due to:
Known infection with human immunodeficiency virus (HIV).
Any bleeding disorder or anticoagulant therapy that would contraindicate IM injection.
Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components.
Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Previous administration of an investigational C difficile vaccine or C difficile mAb therapy.
Receipt of systemic corticosteroids for greater than or equal to 14 days within 28 days before enrollment.
Receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months before enrollment.
Receipt of blood products or immunoglobulins within 6 months before enrollment.
Participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination.
Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or Pfizer employees, including their family members, directly involved in the conduct of the study.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Alabama Research Center, LLC | Athens | Alabama | 35611 | United States | ||
| Medical Affiliated Research Center |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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2160 participants signed the inform consent form (ICF).166 participants were screen failures who did not meet criteria and were not enrolled. 1994 participants were randomized, and 1991 participants received study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 2-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 2, 2019 | Nov 30, 2022 |
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| Placebo | Biological | Normal saline solution (0.9% sodium chloride) |
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| Up to 7 days after Dose 1 of investigational product at Month 0 |
| Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2 | Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 cm. Redness and swelling were graded as mild: 2.5-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, potentially life threatening: necrosis or exfoliative dermatitis for redness, or necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, potentially life threatening: emergency room visit or hospitalization. The maximum severity was defined as highest grading of each local reaction through 7 days of vaccination. | Up to 7 days after Dose 2 of investigational product at Month 1 |
| Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3 | Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 cm. Redness and swelling were graded as mild: 2.5-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, potentially life threatening: necrosis or exfoliative dermatitis for redness, or necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, potentially life threatening: emergency room visit or hospitalization. The maximum severity was defined as highest grading of each local reaction through 7 days of vaccination. | Up to 7 days after Dose 3 of investigational product at Month 6 |
| Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1 | Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild (38.0 to 38.4 degree [deg] Celsius [C]), moderate (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C) and potentially life threatening (>40.0 deg C). Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity and potentially life threatening: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h, severe: required intravenous hydration and potentially life threatening: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event through 7 days of vaccination. | Up to 7 days after Dose 1 of investigational product at Month 0 |
| Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2 | Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild (38.0 to 38.4 deg C), moderate (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C) and potentially life threatening (>40.0 deg C). Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity and potentially life threatening: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h, severe: required intravenous hydration and potentially life threatening: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event through 7 days of vaccination. | Up to 7 days after Dose 2 of investigational product at Month 1 |
| Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3 | Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild (38.0 to 38.4 deg C), moderate (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C) and potentially life threatening (>40.0 deg C). Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity and potentially life threatening: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h, severe: required intravenous hydration and potentially life threatening: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event through 7 days of vaccination. | Up to 7 days after Dose 3 of investigational product at Month 6 |
| Percentage of Participants With Adverse Events Through 1 Month After Last Study Vaccination | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Percentage of participants with any AEs (both serious and all non-serious AEs) and non-serious AEs through 1 month after last study vaccination were reported in this outcome measure. Only AEs and non-SAEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure. | From day of first dose up to 1 month after last dose (up to Month 7) |
| Percentage of Participants With Serious Adverse Events (SAEs) Through 6 Months After Last Study Vaccination | SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | From day of first dose up to 6 months after last dose (up to Month 12) |
| Month 12 |
| Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 12 for EIP | Seroresponse was defined as at least a 4-fold rise from the baseline neutralizing antibody following vaccination. 95% CI was based on Clopper-Pearson method. EI12: all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 165 to 200 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 12; had no major protocol deviations. | Month 12 |
| Huntsville |
| Alabama |
| 35801 |
| United States |
| East Valley Gastroenterology and Hepatology Associates | Chandler | Arizona | 85224 | United States |
| The Pain Center of Arizona | Peoria | Arizona | 85381 | United States |
| HOPE Research Institute | Phoenix | Arizona | 85018 | United States |
| The Pain Center of Arizona | Phoenix | Arizona | 85018 | United States |
| The Pain Center of Arizona | Phoenix | Arizona | 85032 | United States |
| Paradigm Clinical Research Centers, Inc. | La Mesa | California | 91942 | United States |
| Paradigm Clinical Research Centers, Inc. | Redding | California | 96001 | United States |
| Paradigm Research | Wheat Ridge | Colorado | 80033 | United States |
| Innovative Research of West Florida, Inc. | Clearwater | Florida | 33756 | United States |
| Accel Research Sites - DeLand Clinical Research Unit | DeLand | Florida | 32720 | United States |
| Acevedo Clinical Research Associates | Miami | Florida | 33142 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32801 | United States |
| Clinical Neuroscience Solutions, Inc. | Orlando | Florida | 32806 | United States |
| Pines Care Research Center, LLC | Pembroke Pines | Florida | 33026 | United States |
| Progressive Medical Research | Port Orange | Florida | 32127 | United States |
| Meridian Clinical Research, LLC | Savannah | Georgia | 31406 | United States |
| Snake River Research, PLLC | Idaho Falls | Idaho | 83404 | United States |
| MOC Research | Mishawaka | Indiana | 46544 | United States |
| MedPharmics, LLC | Metairie | Louisiana | 70006 | United States |
| MedPharmics, LLC | Gulfport | Mississippi | 39503 | United States |
| Clinical Research Professionals Inc. | Chesterfield | Missouri | 63005 | United States |
| Amici Clinical Research | Raritan | New Jersey | 08869 | United States |
| Rochester Clinical Research, Inc | Rochester | New York | 14609 | United States |
| PMG Research of Charlotte LLC | Charlotte | North Carolina | 28209 | United States |
| PharmQuest | Greensboro | North Carolina | 27408 | United States |
| Accellacare - Hickory | Hickory | North Carolina | 28601 | United States |
| PMG Research of Raleigh | Raleigh | North Carolina | 27609 | United States |
| PMG Research of Wilmington, LLC | Wilmington | North Carolina | 28401 | United States |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Lillestol Research LLC | Fargo | North Dakota | 58104 | United States |
| Aventiv Research Inc. | Columbus | Ohio | 43213 | United States |
| PriMed Clinical Research | Dayton | Ohio | 45419 | United States |
| Medical Research South | Goose Creek | South Carolina | 29445 | United States |
| Main Street Physician's Care - Waterway | Little River | South Carolina | 29566 | United States |
| Coastal Carolina Research Center | North Charleston | South Carolina | 29405 | United States |
| Holston Medical Group | Bristol | Tennessee | 37620 | United States |
| ARC Clinical Research at Wilson Parke | Austin | Texas | 78726 | United States |
| Bellaire Doctor's Clinic | Bellaire | Texas | 77401 | United States |
| Texas Health Care, PLLC | Fort Worth | Texas | 76104 | United States |
| Ventavia Research Group, LLC | Fort Worth | Texas | 76104 | United States |
| Texas Center for Drug Development, Inc. | Houston | Texas | 77081 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| DM Clinical Research | Tomball | Texas | 77375 | United States |
| Martin Diagnostic Clinic | Tomball | Texas | 77375 | United States |
| J. Lewis Research Inc. / Foothill Family Clinic Draper | Draper | Utah | 84020 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic | Salt Lake City | Utah | 84109 | United States |
| J. Lewis Research, Inc. / Foothill Family Clinic South | Salt Lake City | Utah | 84121 | United States |
| J. Lewis Research, Inc. / Jordan River Family Medicine | South Jordan | Utah | 84095 | United States |
| Virginia Research Center LLC | Midlothian | Virginia | 23114 | United States |
| Wenatchee Valley Hospital & Clinics | Wenatchee | Washington | 98801 | United States |
| 3-Dose Clostridium Difficile Vaccine |
Participants were randomized to receive 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
| Vaccinated With Dose 1 |
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| Vaccinated With Dose 2 |
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| Vaccinated With Dose 3 |
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| COMPLETED |
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| NOT COMPLETED |
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The safety analysis set included all participants who received at least 1 dose of the investigational product.
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| ID | Title | Description |
|---|---|---|
| BG000 | 2-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
| BG001 | 3-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Adjusted Geometric Mean Concentration (GMC) of Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibodies at Month 7 for Evaluable Immunogenicity Population (EIP) | Adjusted GMCs and 2-sided 95% confidence intervals (CIs) of toxin A and toxin B specific neutralizing antibody levels were calculated by exponentiating the least square (LS) means and the corresponding CIs based on analysis of logarithmically transformed concentrations using a linear regression model with terms of baseline concentration (log scale) and vaccine group. EIP at Month 7 (EI7): all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 28 to 47 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 7; had no major protocol deviations. | EI7 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point. | Posted | Geometric Mean | 95% Confidence Interval | Neutralization units per milliliter | Month 7 |
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| Primary | Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 7 for EIP | Seroresponse was defined as at least a 4-fold rise from the baseline neutralizing antibody level following vaccination. 95% CI was based on Clopper-Pearson method. EI7: all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 28 to 47 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 7; had no major protocol deviations. | EI7 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 7 |
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| Primary | Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 1 | Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 centimeter (cm). Redness and swelling were graded as mild: 2.5-5.0 cm, moderate: greater than (>) 5.0-10.0 cm, severe: >10.0 cm, potentially life threatening: necrosis or exfoliative dermatitis for redness, or necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, potentially life threatening: emergency room visit or hospitalization. The maximum severity was defined as highest grading of each local reaction through 7 days of vaccination. | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 7 days after Dose 1 of investigational product at Month 0 |
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| Primary | Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 2 | Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 cm. Redness and swelling were graded as mild: 2.5-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, potentially life threatening: necrosis or exfoliative dermatitis for redness, or necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, potentially life threatening: emergency room visit or hospitalization. The maximum severity was defined as highest grading of each local reaction through 7 days of vaccination. | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 7 days after Dose 2 of investigational product at Month 1 |
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| Primary | Percentage of Participants With Local Reactions by Maximum Severity Through 7 Days After Dose 3 | Local reactions included pain at injection site, redness and swelling. These were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units, where 1 measuring device unit= 0.5 cm. Redness and swelling were graded as mild: 2.5-5.0 cm, moderate: >5.0-10.0 cm, severe: >10.0 cm, potentially life threatening: necrosis or exfoliative dermatitis for redness, or necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity, potentially life threatening: emergency room visit or hospitalization. The maximum severity was defined as highest grading of each local reaction through 7 days of vaccination. | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 7 days after Dose 3 of investigational product at Month 6 |
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| Primary | Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 1 | Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild (38.0 to 38.4 degree [deg] Celsius [C]), moderate (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C) and potentially life threatening (>40.0 deg C). Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity and potentially life threatening: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h, severe: required intravenous hydration and potentially life threatening: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event through 7 days of vaccination. | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 7 days after Dose 1 of investigational product at Month 0 |
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| Primary | Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 2 | Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild (38.0 to 38.4 deg C), moderate (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C) and potentially life threatening (>40.0 deg C). Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity and potentially life threatening: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h, severe: required intravenous hydration and potentially life threatening: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event through 7 days of vaccination. | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 7 days after Dose 2 of investigational product at Month 1 |
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| Primary | Percentage of Participants With Systemic Events by Maximum Severity Through 7 Days After Dose 3 | Systemic events included fever, fatigue, headache, joint pain, muscle pain and vomiting. These were recorded by participants in an e-diary. Fever was categorized as: mild (38.0 to 38.4 deg C), moderate (38.5 to 38.9 deg C), severe (39.0 to 40.0 deg C) and potentially life threatening (>40.0 deg C). Fatigue, headache, muscle pain and joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity, severe: prevented daily routine activity and potentially life threatening: emergency room visit or hospitalization. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h, severe: required intravenous hydration and potentially life threatening: emergency room visit or hospitalization for hypotensive shock. The maximum severity was defined as highest grading of each systemic event through 7 days of vaccination. | Safety analysis set included all participants who received at least 1 dose of the investigational product. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Number | 95% Confidence Interval | Percentage of participants | Up to 7 days after Dose 3 of investigational product at Month 6 |
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| Primary | Percentage of Participants With Adverse Events Through 1 Month After Last Study Vaccination | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. Percentage of participants with any AEs (both serious and all non-serious AEs) and non-serious AEs through 1 month after last study vaccination were reported in this outcome measure. Only AEs and non-SAEs collected by non-systematic assessment (i.e., excluding local reactions and systemic events) were reported in this outcome measure. | Safety analysis set included all participants who received at least 1 dose of the investigational product. | Posted | Number | Percentage of participants | From day of first dose up to 1 month after last dose (up to Month 7) |
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| Primary | Percentage of Participants With Serious Adverse Events (SAEs) Through 6 Months After Last Study Vaccination | SAE was any untoward medical occurrence that at any dose resulted in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Safety analysis set included all participants who received at least 1 dose of the investigational product. | Posted | Number | Percentage of participants | From day of first dose up to 6 months after last dose (up to Month 12) |
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| Secondary | Adjusted Geometric Mean Concentration for Clostridium Difficile Toxin A and Toxin B Specific Neutralizing Antibody at Month 12 for EIP | Adjusted GMCs and 2-sided 95% CIs of toxin A and toxin B specific neutralizing antibody levels were calculated by exponentiating the LS means and the corresponding CIs based on analysis of logarithmically transformed concentrations using a linear regression model with terms of baseline concentration (log scale) and vaccine group. EI12: all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 165 to 200 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 12; had no major protocol deviations. | EI12 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point. | Posted | Geometric Mean | 95% Confidence Interval | Neutralization units per milliliter | Month 12 |
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| Secondary | Percentage of Participants Achieving Seroresponse for Clostridium Difficile Toxin A and Toxin B at Month 12 for EIP | Seroresponse was defined as at least a 4-fold rise from the baseline neutralizing antibody following vaccination. 95% CI was based on Clopper-Pearson method. EI12: all enrolled participants who received all 3 doses of investigational product; had blood drawn for assay testing within 165 to 200 days after visit 4; had valid and determinate assay results for either toxin A or B for the specified analysis at Month 12; had no major protocol deviations. | EI12 population. All participants reported under 'Number of Participants Analyzed' contributed data to the table; however, may not have evaluable data for every row. "Number Analyzed" signifies participants with valid and determinate assay results for the specified assay at both baseline and the given sampling time point. | Posted | Number | 95% Confidence Interval | Percentage of participants | Month 12 |
|
Local reactions and systemic events: within 7 days after vaccination (systematic assessment), other AEs: from Day 1 up to 1 month after last dose of vaccination (up to Month 7), all-cause mortality and SAEs: from Day 1 up to 6 months after last dose of vaccination (up to Month 12)
Same event may appear as both an AE and SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety set was evaluated.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 2-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0) and visit 4 (Month 6) and 1 dose of placebo (0.9% sodium chloride) at visit 2 (Month 1). Participants were followed up to 6 months after last dose of vaccination at Month 6. | 15 | 994 | 141 | 994 | 721 | 994 |
| EG001 | 3-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. | 7 | 997 | 136 | 997 | 751 | 997 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Blood loss anaemia | Blood and lymphatic system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arteriosclerosis coronary artery | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardiogenic shock | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardiomegaly | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ischaemic cardiomyopathy | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Mitral valve incompetence | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sinus node dysfunction | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Familial amyloidosis | Congenital, familial and genetic disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Colitis ischaemic | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Duodenal ulcer | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Duodenal vascular ectasia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haematemesis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hiatus hernia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ileus | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Obstructive pancreatitis | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Umbilical hernia | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Death | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Multiple organ dysfunction syndrome | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bile duct stone | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Biliary dyskinesia | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cholangitis | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Epididymitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Escherichia infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Escherichia pyelonephritis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Escherichia urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastroenteritis salmonella | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Metapneumovirus pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia aspiration | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia influenzal | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumonia viral | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pulmonary sepsis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pyelonephritis acute | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Anaemia postoperative | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cardiac valve replacement complication | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cervical vertebral fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Face injury | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Facial bones fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fibula fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Gastrointestinal procedural complication | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hip fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Incisional hernia, obstructive | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intentional overdose | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Post procedural hypotension | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thermal burn | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Compartment syndrome | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Neuroendocrine carcinoma of the skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ovarian cancer stage I | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Rectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bell's palsy | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Brain injury | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Encephalopathy | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Essential tremor | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Haemorrhagic stroke | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Intracranial mass | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lacunar infarction | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nerve compression | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Spinal cord compression | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Transient global amnesia | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA v24.1 | Non-systematic Assessment |
| |
| Device occlusion | Product Issues | MedDRA v24.1 | Non-systematic Assessment |
| |
| Alcohol withdrawal syndrome | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Behaviour disorder | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Bipolar disorder | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Drug abuse | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Homicidal ideation | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Suicidal behaviour | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| End stage renal disease | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertensive nephropathy | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Renal injury | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Renal mass | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Renal tubular acidosis | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ureteric stenosis | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Emphysema | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypercapnia | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Diabetic foot | Skin and subcutaneous tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Multiple drug therapy | Surgical and medical procedures | MedDRA v24.1 | Non-systematic Assessment |
| |
| Oesophagogastric fundoplasty | Surgical and medical procedures | MedDRA v24.1 | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arterial stenosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Lymphoedema | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Shock | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Vomiting (VOMITING) | Gastrointestinal disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fatigue (FATIGUE) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Injection site erythema (REDNESS) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Injection site pain (PAIN) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Injection site swelling (SWELLING) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Pyrexia (FEVER) | General disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v24.1 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Arthralgia (JOINT PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Myalgia (MUSCLE PAIN) | Musculoskeletal and connective tissue disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v24.1 | Non-systematic Assessment |
| |
| Headache (HEADACHE) | Nervous system disorders | MedDRA v24.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v24.1 | Non-systematic Assessment |
|
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 29, 2020 | Nov 30, 2022 | SAP_001.pdf |
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Toxin B |
|
|
| Toxin B | Adjusted Geometric Mean Ratio | 0.57 | 2-Sided | 95 | 0.49 | 0.66 | Adjusted GMR was estimated by the ratio of the adjusted GMCs (adjusted for baseline concentrations). CIs based on the student t distribution for the mean difference in logarithmic scale. | Non-Inferiority | The noninferiority objective was achieved if the lower limit of the 95% CI for GMR was >0.67 for both Toxin A and Toxin B. |
|
|
|
| 3-Dose Clostridium Difficile Vaccine |
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
|
|
| 3-Dose Clostridium Difficile Vaccine |
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
|
|
| 3-Dose Clostridium Difficile Vaccine |
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
|
|
| OG001 | 3-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
|
|
| OG001 | 3-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
|
|
| OG001 | 3-Dose Clostridium Difficile Vaccine | Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
|
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
Participants received 1 dose of toxin-based Clostridium difficile vaccine intramuscularly at visit 1 (Month 0), visit 2 (Month 1), and visit 4 (Month 6). Participants were followed up to 6 months after last dose of vaccination at Month 6. |
|
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