A Study to Learn About a Vaccine Against E Coli in Healthy Adults
This study is testing several investigational vaccines (E coli vaccine 1 Dose A, E coli vaccine 1 Dose B, E coli vaccine 2, E coli vaccine 3, and E coli Vaccine 4 Dose A) designed to protect against E. coli bacteria. The main goal is to see how safe these vaccines are and how well healthy adults tolerate them. Researchers will be looking at any side effects you might have, like soreness at the injection site or other body-wide reactions, within 7 days after each shot. They will also track any other side effects for up to one month after your last vaccine dose. This study is currently unclear on its status and plans to enroll about 310 healthy adults between 18 and 64 years old.
- Study design
- This interventional study is testing different E. coli vaccines in healthy adults. It plans to enroll about 310 participants.
- What's involved
- You would receive two doses of an E. coli vaccine over a 6-month period. Researchers will monitor you for side effects for 7 days after each vaccination and for one month after your final dose.
- Compensation
- Not stated in the trial record.
- Follow-up
- You will be followed for side effects for 7 days after each vaccination and for one month after your last assigned vaccination.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Learn About a Vaccine Against E Coli in Healthy Adults
At a glance
Conditions
Where it's being run
11 sites across 5 statesStudy leadership
- Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer
Who to contact
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What this trial measures
- Percentage of participants reporting prespecified local events within 7 days following each vaccination7 days after each vaccination
Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination
- Percentage of participants reporting prespecified systemic events within 7 days following each vaccination7 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 Adverse Events (AEs) from vaccination 1 through 1 month after the last dose of study interventionFrom 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 interventionBaseline 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 interventionBaseline 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