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E. coli vaccine 4

Phase 1

Healthy Participants | Small molecule | Other |Pfizer, Inc.|Last Updated: Apr 30, 2026

Target and mechanism

ModalitySmall molecule

Also known as E coli vaccine 1 Dose A, E coli vaccine 1 Dose B, E coli vaccine 2, E coli Vaccine 4 Dose C

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment310

FDA Designations

No designations recorded

Clinical trial landscape

E. coli vaccine 4 · 1 trial · 1 indication

Phase 1 1
NCT07122986A Study to Learn About a Vaccine Against E Coli in Healthy AdultsHealthy Participants
RECRUITING310 Analytics
PHASE1RECRUITING
A Study to Learn About a Vaccine Against E Coli in Healthy Adults
Healthy Participants
NCT07122986310
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Study Endpoints

Primary Endpoints

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 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 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

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
E coli vaccine 1 Dose AEXPERIMENTALCandidate E coli vaccine on day 1 and day 180
E coli vaccine 1 Dose BEXPERIMENTALCandidate E coli vaccine on day 1 and day 180
E coli vaccine 2EXPERIMENTALCandidate E coli vaccine on day 1 and day 180
E coli vaccine 3EXPERIMENTALCandidate E coli vaccine on day 1 and day 180
E coli Vaccine 4 Dose AEXPERIMENTALCandidate E coli vaccine on day 1 and day 180
E coli Vaccine 4 Dose BEXPERIMENTALCandidate E coli vaccine on day 1 and day 180
E coli Vaccine 4 Dose CEXPERIMENTALCandidate E coli vaccine on day 1 and day 180
E coli Vaccine 5 Dose AEXPERIMENTAL -
E coli Vaccine 5 Dose BEXPERIMENTAL -
PlaceboEXPERIMENTALPlacebo received on day 1 and day 180

Interventions

NameTypeDescription
E coli vaccine 1 Dose ADRUGCandidate E coli vaccine 1 Dose A, administered according to a 0, 6-month interval
E coli vaccine 1 Dose BDRUGCandidate E coli vaccine 1 Dose B, administered according to a 0, 6-month interval
E coli vaccine 2DRUGCandidate E coli vaccine 2, administered according to a 0, 6-month interval
E coli vaccine 3DRUGCandidate E coli vaccine 3, administered according to a 0, 6-month interval
E coli Vaccine 4 Dose ADRUGCandidate E coli vaccine 4 Dose A, administered according to a 0, 6-month interval
E coli Vaccine 4 Dose BDRUGCandidate E coli vaccine 4 Dose B, administered according to a 0, 6-month interval
E coli Vaccine 4 Dose CDRUGCandidate E coli vaccine 4 Dose C, administered according to a 0, 6-month interval
E coli Vaccine 5 Dose ADRUGCandidate E coli vaccine 5 Dose A, administered according to a 0, 6-month interval
E coli Vaccine 5 Dose BDRUGCandidate E coli vaccine 5 Dose B, administered according to a 0, 6-month interval
PlaceboDRUGPlacebo administered according to a 0, 6-month interval
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersYes
Study Sites11

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, an...

Countries:United States
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