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A Study to Learn About a Vaccine Against E Coli in Healthy Adults | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study to Learn About a Vaccine Against E Coli in Healthy Adults

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

NCT07122986•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Ages Eligible for Study: 18 to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes
•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.

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.

Locations (11)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Orange County Research Center

Lake Forest, California, United States

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Miami Eye Institute

Hollywood, Florida, United States

Research Centers of America

Hollywood, Florida, United States

NYU Langone Health

New York, New York, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Senders Pediatrics

South Euclid, Ohio, United States

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States

Key Dates

Start Date

August 11, 2025

Primary Completion Date

May 26, 2028

Completion Date

May 26, 2028

Last Updated

January 21, 2026

Enrollment

310

ESTIMATED participants

Conditions

Healthy Participants

Interventions

E coli vaccine 1 Dose A

DRUG

E coli vaccine 1 Dose B

DRUG

E coli vaccine 2

DRUG

E coli vaccine 3

DRUG

E coli Vaccine 4 Dose A

DRUG

E coli Vaccine 4 Dose B

DRUG

E coli Vaccine 4 Dose C

DRUG

E coli Vaccine 5 Dose A

DRUG

E coli Vaccine 5 Dose B

DRUG

Placebo

DRUG

Contacts

Pfizer CT.gov Call Center

CONTACT

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

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Obese But Otherwise Healthy Participants

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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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Healthy ParticipantsHealthy Subjects+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Study to Learn About a Vaccine Against E Coli in Healthy Adults

Inclusion Criteria

Exclusion Criteria

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