> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-a-vaccine-against-e-coli-in-healthy-89601220-8dfb-4fd1-9def-253f7cee3da4 > Record changed: 2026-10-13 # A Study to Learn About a Vaccine Against E Coli in Healthy Adults NCT07122986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) Participants 310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) Start date 2025-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Short title** A Study to Learn About a Vaccine Against E Coli in Healthy Adults Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Official title** A PHASE 1, RANDOMIZED, DOUBLE-BLIND, THIRD-PARTY-UNBLINDED STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF A VACCINE AGAINST E COLI IN HEALTHY ADULTS Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Status and phase **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Dates **Completion date** 2028-05-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **First posted** 2025-08-14 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Registry last updated** 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Primary completion date** 2028-05-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Start date** 2025-08-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Size and sites **Participants** 310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Planned participants** 310 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Identifiers **Registry ID** NCT07122986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **ClinicalTrials.gov ID** NCT07122986 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** Double masking **Masked roles** Participants, Care providers Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Outcomes ### Primary outcomes 1. Percentage of participants reporting prespecified local events within 7 days following each vaccination Timeframe: 7 days after each vaccination Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination 2. Percentage of participants reporting prespecified systemic events within 7 days following each vaccination Timeframe: 7 days after each vaccination Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) following each vaccination 3. Percentage of participants reporting Adverse Events (AEs) from vaccination 1 through 1 month after the last dose of study intervention Timeframe: From signing of ICD to 1 month after the last assigned vaccination Adverse events occurring up to 1 month after the last dose of study intervention 4. Percentage of participants reporting Medically Attended Adverse Events (MAEs) from vaccination 1 through 12 months after the last dose of study intervention Timeframe: Baseline up to month 18 with final visit being 12 months after last assigned vaccination MAEs occurring up to 12 months after the last dose of study intervention 5. Percentage of participants reporting Serious Adverse Events (SAEs) from vaccination 1 through 12 months after the last dose of study intervention Timeframe: Baseline up to month 18 with final visit being 12 months after last assigned vaccination SAEs occurring up to 12 months after the last dose of study intervention Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 64 Years **Healthy volunteers** Yes Ages Eligible for Study: 18 to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Key Inclusion Criteria 1. Adult Participants >= 18 through < 64 years of age at the time of enrollment. 2. Healthy participants as determined by medical history, physical examination, and clinical judgement of the investigator to be eligible for inclusion in the study. Key Exclusion Criteria 1. Severe adverse reaction history associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s). 2. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination. 3. Women who are pregnant, plan to become pregnant during the study, or are breastfeeding. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Sites - Anaheim Clinical Trials, LLCAnaheim, United StatesRecruiting - Orange County Research CenterLake Forest, United StatesRecruiting - Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting - Miami Eye InstituteHollywood, United StatesRecruiting - Research Centers of AmericaHollywood, United StatesRecruiting - NYU Langone HealthNew York, United StatesRecruiting - CTI Clinical Research CenterCincinnati, United StatesRecruiting - Senders PediatricsSouth Euclid, United StatesRecruiting - Alliance for Multispecialty Research, LLCKnoxville, United StatesRecruiting - Alliance for Multispecialty Research, LLCKnoxville, United StatesRecruiting - University Eye Specialists, P.C. (Ophthalmologist)Maryville, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C5211001) Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07122986) ## Related records ### Drugs (1) - [Ledismase](https://trialight.com/data/asset/ledismase-176da9be-9dac-40ac-b550-0c9ffa897386.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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