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

NCT ID: NCT07122986

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

310 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-11

Study Completion Date

2028-05-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Participants

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

E coli vaccine 1 Dose A

Candidate E coli vaccine on day 1 and day 180

Group Type EXPERIMENTAL

E coli vaccine 1 Dose A

Intervention Type DRUG

Candidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval

E coli vaccine 1 Dose B

Candidate E coli vaccine on day 1 and day 180

Group Type EXPERIMENTAL

E coli vaccine 1 Dose B

Intervention Type DRUG

Candidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval

E coli vaccine 2

Candidate E coli vaccine on day 1 and day 180

Group Type EXPERIMENTAL

E coli vaccine 2

Intervention Type DRUG

Candidate E coli vaccine 2, administered according to a 0, 6-month interval

E coli vaccine 3

Candidate E coli vaccine on day 1 and day 180

Group Type EXPERIMENTAL

E coli vaccine 3

Intervention Type DRUG

Candidate E coli vaccine 3, administered according to a 0, 6-month interval

E coli Vaccine 4 Dose A

Candidate E coli vaccine on day 1 and day 180

Group Type EXPERIMENTAL

E coli Vaccine 4 Dose A

Intervention Type DRUG

Candidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval

E coli Vaccine 4 Dose B

Candidate E coli vaccine on day 1 and day 180

Group Type EXPERIMENTAL

E coli Vaccine 4 Dose B

Intervention Type DRUG

Candidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval

E coli Vaccine 4 Dose C

Candidate E coli vaccine on day 1 and day 180

Group Type EXPERIMENTAL

E coli Vaccine 4 Dose C

Intervention Type DRUG

Candidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval

E coli Vaccine 5 Dose A

Group Type EXPERIMENTAL

E coli Vaccine 5 Dose A

Intervention Type DRUG

Candidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval

E coli Vaccine 5 Dose B

Group Type EXPERIMENTAL

E coli Vaccine 5 Dose B

Intervention Type DRUG

Candidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval

Placebo

Placebo received on day 1 and day 180

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Placebo administered according to a 0, 6-month interval

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

E coli vaccine 1 Dose A

Candidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval

Intervention Type DRUG

E coli vaccine 1 Dose B

Candidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval

Intervention Type DRUG

E coli vaccine 2

Candidate E coli vaccine 2, administered according to a 0, 6-month interval

Intervention Type DRUG

E coli vaccine 3

Candidate E coli vaccine 3, administered according to a 0, 6-month interval

Intervention Type DRUG

E coli Vaccine 4 Dose A

Candidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval

Intervention Type DRUG

E coli Vaccine 4 Dose B

Candidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval

Intervention Type DRUG

E coli Vaccine 4 Dose C

Candidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval

Intervention Type DRUG

E coli Vaccine 5 Dose A

Candidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval

Intervention Type DRUG

E coli Vaccine 5 Dose B

Candidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval

Intervention Type DRUG

Placebo

Placebo administered according to a 0, 6-month interval

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Site Status RECRUITING

Orange County Research Center

Lake Forest, California, United States

Site Status RECRUITING

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status RECRUITING

Miami Eye Institute

Hollywood, Florida, United States

Site Status RECRUITING

Research Centers of America

Hollywood, Florida, United States

Site Status RECRUITING

NYU Langone Health

New York, New York, United States

Site Status RECRUITING

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Senders Pediatrics

South Euclid, Ohio, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States

Site Status RECRUITING

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, United States

Site Status RECRUITING

University Eye Specialists, P.C. (Ophthalmologist)

Maryville, Tennessee, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Pfizer CT.gov Call Center

Role: CONTACT

1-800-718-1021

Related Links

Access external resources that provide additional context or updates about the study.

https://pmiform.com/clinical-trial-info-request?StudyID=C5211001

To obtain contact information for a study center near you, click here.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C5211001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Challenge Study of an ETEC Vaccine
NCT01922856 COMPLETED PHASE2
Phase I Study With V-212 Vaccinations in Healthy Adult Volunteers
NCT06975319 ACTIVE_NOT_RECRUITING EARLY_PHASE1