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

Not Applicable

Not yet recruiting

• Conditions: Healthy Participants
• Interventions: Drug: 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

• Registration Number: NCT07122986
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-07
• Study First Submitted QC: 2025-08-07
• Last Update Submitted: 2025-08-07
• Study Start: 2025-08-13
• Study First Posted: 2025-08-14
• Last Update Posted: 2025-08-14
• Primary Completion: 2028-05-25
• Study Completion: 2028-05-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
E coli vaccine 1 Dose A	E coli vaccine 1 Dose A	Candidate E coli vaccine on day 1 and day 180
E coli vaccine 1 Dose B	E coli vaccine 1 Dose B	Candidate E coli vaccine on day 1 and day 180
E coli vaccine 2	E coli vaccine 2	Candidate E coli vaccine on day 1 and day 180
E coli vaccine 3	E coli vaccine 3	Candidate E coli vaccine on day 1 and day 180
E coli Vaccine 4 Dose A	E coli Vaccine 4 Dose A	Candidate E coli vaccine on day 1 and day 180
E coli Vaccine 4 Dose B	E coli Vaccine 4 Dose B	Candidate E coli vaccine on day 1 and day 180
E coli Vaccine 4 Dose C	E coli Vaccine 4 Dose C	Candidate E coli vaccine on day 1 and day 180
E coli Vaccine 5 Dose A	E coli Vaccine 5 Dose A	-
E coli Vaccine 5 Dose B	E coli Vaccine 5 Dose B	-
Placebo	Placebo	Placebo received on day 1 and day 180

Primary Outcome Measures

Name	Time	Method
Percentage of participants reporting prespecified systemic events within 7 days following each vaccination	7 days after each vaccination	Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) following each vaccination
Percentage of participants reporting prespecified local events within 7 days following each vaccination	7 days after each vaccination	Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination
Percentage of participants reporting Adverse Events (AEs) from vaccination 1 through 1 month after the last dose of study intervention	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
Percentage of participants reporting Medically Attended Adverse Events (MAEs) from vaccination 1 through 12 months after the last dose of study intervention	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
Percentage of participants reporting Serious Adverse Events (SAEs) from vaccination 1 through 12 months after the last dose of study intervention	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

Trial Locations

Locations (2)

Diablo Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, United States

CTI Clinical Research Center; 🇺🇸 Cincinnati, Ohio, United States