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NCT Number: NCT07122986

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

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.

Recruiting

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Key information

Conditions

Healthy Participants

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Key Inclusion Criteria

  • Adult Participants >= 18 through < 64 years of age at the time of enrollment.
  • 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

  • Severe adverse reaction history associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  • Women who are pregnant, plan to become pregnant during the study, or are breastfeeding.

Treatment and study plan

E coli vaccine 1 Dose A

Drug

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

E coli vaccine 1 Dose B

Drug

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

E coli vaccine 2

Drug

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

E coli vaccine 3

Drug

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

E coli Vaccine 4 Dose A

Drug

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

E coli Vaccine 4 Dose B

Drug

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

E coli Vaccine 4 Dose C

Drug

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

E coli Vaccine 5 Dose A

Drug

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

E coli Vaccine 5 Dose B

Drug

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

Placebo

Drug

Placebo administered according to a 0, 6-month interval

Primary outcomes

  1. Percentage of participants reporting prespecified local events within 7 days following each vaccination

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 14, 2025
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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