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

Phase 1RecruitingNCT07122986

Pfizer310 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

310

Conditions

Healthy Participants

Interventions

E coli vaccine 1 Dose ADRUG

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

E coli vaccine 1 Dose BDRUG

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

E coli vaccine 2DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (11)

Anaheim Clinical Trials, LLC

Anaheim, California, United States

RECRUITING

Orange County Research Center

Lake Forest, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination

Time frame: 7 days after each vaccination

Percentage of participants reporting prespecified systemic events within 7 days following each vaccination

Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) 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

Adverse events occurring up to 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

MAEs occurring up to 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

SAEs occurring up to 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

Pfizer CT.gov Call Center

CONTACT

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

Data from ClinicalTrials.gov

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