NCT07122986

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 310 (estimated)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	E coli vaccine 1 Dose A	Candidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval
DRUG	E coli vaccine 1 Dose B	Candidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval
DRUG	E coli vaccine 2	Candidate E coli vaccine 2, administered according to a 0, 6-month interval
DRUG	E coli vaccine 3	Candidate E coli vaccine 3, administered according to a 0, 6-month interval
DRUG	E coli Vaccine 4 Dose A	Candidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval
DRUG	E coli Vaccine 4 Dose B	Candidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval
DRUG	E coli Vaccine 4 Dose C	Candidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval
DRUG	E coli Vaccine 5 Dose A	Candidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval
DRUG	E coli Vaccine 5 Dose B	Candidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval
DRUG	Placebo	Placebo administered according to a 0, 6-month interval

Timeline

• Start date: 2025-08-11
• Primary completion: 2028-05-26
• Completion: 2028-05-26
• First posted: 2025-08-14
• Last updated: 2026-01-21

Locations

11 sites across 1 country: United States

Regulatory

• FDA-regulated drug study