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This study evaluates an investigational vaccine designed to protect against Escherichia coli (E coli). The primary objective is to assess the safety and tolerability of E coli vaccines administered intramuscularly to healthy adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E coli vaccine 1 Dose A | Experimental | Candidate E coli vaccine on day 1 and day 180 |
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| E coli vaccine 1 Dose B | Experimental | Candidate E coli vaccine on day 1 and day 180 |
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| E coli vaccine 2 | Experimental | Candidate E coli vaccine on day 1 and day 180 |
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| E coli vaccine 3 | Experimental | Candidate E coli vaccine on day 1 and day 180 |
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| E coli Vaccine 4 Dose A | Experimental | Candidate E coli vaccine on day 1 and day 180 |
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| E coli Vaccine 4 Dose B | Experimental | Candidate E coli vaccine on day 1 and day 180 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| E coli vaccine 1 Dose A | Drug | Candidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting prespecified local events within 7 days following each vaccination | Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination | 7 days after each vaccination |
| Percentage of participants reporting prespecified systemic events within 7 days following each vaccination | Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) following each vaccination | 7 days after each vaccination |
| Percentage of participants reporting Adverse Events (AEs) from vaccination 1 through 1 month after the last dose of study intervention | Adverse events occurring up to 1 month after the last dose of study intervention | From signing of ICD to 1 month after the last assigned vaccination |
| Percentage of participants reporting Medically Attended Adverse Events (MAEs) from vaccination 1 through 12 months after the last dose of study intervention | MAEs occurring up to 12 months after the last dose of study intervention | Baseline up to month 18 with final visit being 12 months after last assigned vaccination |
| Percentage of participants reporting Serious Adverse Events (SAEs) from vaccination 1 through 12 months after the last dose of study intervention | SAEs occurring up to 12 months after the last dose of study intervention | Baseline up to month 18 with final visit being 12 months after last assigned vaccination |
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Ages Eligible for Study: 18 to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes
Key Inclusion Criteria
Key Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials, LLC | Recruiting | Anaheim | California | 92801 | United States | |
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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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| E coli Vaccine 4 Dose C | Experimental | Candidate E coli vaccine on day 1 and day 180 |
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| E coli Vaccine 5 Dose A | Experimental |
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| E coli Vaccine 5 Dose B | Experimental |
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| Placebo | Experimental | Placebo received on day 1 and day 180 |
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| E coli vaccine 1 Dose B | Drug | Candidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval |
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| E coli vaccine 2 | Drug | Candidate E coli vaccine 2, administered according to a 0, 6-month interval |
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| E coli vaccine 3 | Drug | Candidate E coli vaccine 3, administered according to a 0, 6-month interval |
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| E coli Vaccine 4 Dose A | Drug | Candidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval |
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| E coli Vaccine 4 Dose B | Drug | Candidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval |
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| E coli Vaccine 4 Dose C | Drug | Candidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval |
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| E coli Vaccine 5 Dose A | Drug | Candidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval |
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| E coli Vaccine 5 Dose B | Drug | Candidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval |
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| Placebo | Drug | Placebo administered according to a 0, 6-month interval |
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| Orange County Research Center |
| Recruiting |
| Lake Forest |
| California |
| 92630 |
| United States |
| Diablo Clinical Research, Inc. | Recruiting | Walnut Creek | California | 94598 | United States |
| Miami Eye Institute | Recruiting | Hollywood | Florida | 33024 | United States |
| Research Centers of America | Recruiting | Hollywood | Florida | 33024 | United States |
| NYU Langone Health | Recruiting | New York | New York | 10016 | United States |
| CTI Clinical Research Center | Recruiting | Cincinnati | Ohio | 45212 | United States |
| Senders Pediatrics | Recruiting | South Euclid | Ohio | 44121 | United States |
| Alliance for Multispecialty Research, LLC | Recruiting | Knoxville | Tennessee | 37909 | United States |
| Alliance for Multispecialty Research, LLC | Recruiting | Knoxville | Tennessee | 37920 | United States |
| University Eye Specialists, P.C. (Ophthalmologist) | Recruiting | Maryville | Tennessee | 37803 | United States |