Recruiting
Phase 1

E Coli Vaccine

Sponsor:

Pfizer

Code:

NCT07122986

Conditions

Healthy Participants

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

Interventions

E coli vaccine 1 Dose A

E coli vaccine 1 Dose B

E coli vaccine 2

E coli vaccine 3

E coli Vaccine 4 Dose A

Study Details

Brief 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.

Conditions

Healthy Participants

Study ID

NCT07122986

Start date

Aug 11, 2025

Status verified date

Apr, 2026

Completion date

May 26, 2028

Anticipated

Primary completion date

May 26, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

310 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: E coli vaccine 1 Dose A

Candidate E coli vaccine on day 1 and day 180

experimental: E coli vaccine 1 Dose B

Candidate E coli vaccine on day 1 and day 180

experimental: E coli vaccine 2

Candidate E coli vaccine on day 1 and day 180

experimental: E coli vaccine 3

Candidate E coli vaccine on day 1 and day 180

experimental: E coli Vaccine 4 Dose A

Candidate E coli vaccine on day 1 and day 180

experimental: E coli Vaccine 4 Dose B

Candidate E coli vaccine on day 1 and day 180

experimental: E coli Vaccine 4 Dose C

Candidate E coli vaccine on day 1 and day 180

experimental: E coli Vaccine 5 Dose A

experimental: E coli Vaccine 5 Dose B

experimental: Placebo

Placebo received on day 1 and day 180

Interventions

E coli vaccine 1 Dose A

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 1 Dose B, administered according to a 0, 6-month interval

E coli vaccine 2

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

E coli vaccine 3

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

E coli Vaccine 4 Dose A

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 4 Dose B, administered according to a 0, 6-month interval

E coli Vaccine 4 Dose C

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

E coli Vaccine 5 Dose A

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

E coli Vaccine 5 Dose B

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

Placebo

Placebo administered according to a 0, 6-month interval

Primary outcome measure

  • Percentage of participants reporting prespecified local events within 7 days following each vaccination [ Time Frame: 7 days after each vaccination ]
  • Percentage of participants reporting prespecified systemic events within 7 days following each vaccination [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Baseline up to month 18 with final visit being 12 months after last assigned vaccination ]

Central Contacts and Locations

Central contacts

Pfizer CT.gov Call Center

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

Locations

Anaheim Clinical Trials, LLC

Recruiting

Anaheim, California, United States, 92801

Orange County Research Center

Recruiting

Lake Forest, California, United States, 92630

Diablo Clinical Research, Inc.

Recruiting

Walnut Creek, California, United States, 94598

Miami Eye Institute

Recruiting

Hollywood, Florida, United States, 33024

Research Centers of America

Recruiting

Hollywood, Florida, United States, 33024

NYU Langone Health

Recruiting

New York, New York, United States, 10016

CTI Clinical Research Center

Recruiting

Cincinnati, Ohio, United States, 45212

Senders Pediatrics

Recruiting

South Euclid, Ohio, United States, 44121

Alliance for Multispecialty Research, LLC

Recruiting

Knoxville, Tennessee, United States, 37909

Alliance for Multispecialty Research, LLC

Recruiting

Knoxville, Tennessee, United States, 37920

University Eye Specialists, P.C. (Ophthalmologist)

Recruiting

Maryville, Tennessee, United States, 37803

More Information

Sponsor

Pfizer

Last update posted

Apr 30, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-14. This information was provided to ClinicalTrials.gov by Pfizer on 2026-04-30.