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

Part of paid clinical trials in Anaheim, California.

Sponsor
Pfizer
Study ID
NCT07122986
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Healthy Participants

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 11, 2025
Status verified
Apr 2026
Primary completion
May 26, 2028
Completion
May 26, 2028

Study Design

Enrollment
310 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: E coli vaccine 1 Dose A
    Candidate E coli vaccine on day 1 and day 180
  • Experimental: E coli vaccine 1 Dose B
    Candidate E coli vaccine on day 1 and day 180
  • Experimental: E coli vaccine 2
    Candidate E coli vaccine on day 1 and day 180
  • Experimental: E coli vaccine 3
    Candidate E coli vaccine on day 1 and day 180
  • Experimental: E coli Vaccine 4 Dose A
    Candidate E coli vaccine on day 1 and day 180
  • Experimental: E coli Vaccine 4 Dose B
    Candidate E coli vaccine on day 1 and day 180
  • Experimental: E coli Vaccine 4 Dose C
    Candidate E coli vaccine on day 1 and day 180
  • Experimental: E coli Vaccine 5 Dose A
  • Experimental: E coli Vaccine 5 Dose B
  • Experimental: Placebo
    Placebo received on day 1 and day 180

Primary Outcome Measure

Percentage of participants reporting prespecified local events within 7 days following each vaccination [ Time Frame: 7 days after each vaccination ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Anaheim Clinical Trials, LLCAnaheimCalifornia92801-
Orange County Research CenterLake ForestCalifornia92630-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Miami Eye InstituteHollywoodFlorida33024-
Research Centers of AmericaHollywoodFlorida33024-
NYU Langone HealthNew YorkNew York10016-
CTI Clinical Research CenterCincinnatiOhio45212-
Senders PediatricsSouth EuclidOhio44121-
Alliance for Multispecialty Research, LLCKnoxvilleTennessee37909-
Alliance for Multispecialty Research, LLCKnoxvilleTennessee37920-
University Eye Specialists, P.C. (Ophthalmologist)MaryvilleTennessee37803-

Find similar trials in Anaheim, CA

By research site
Anaheim Clinical Trials, LLC· Anaheim, CAOrange County Research Center· Lake Forest, CADiablo Clinical Research, Inc.· Walnut Creek, CAMiami Eye Institute· Hollywood, FLResearch Centers of America· Hollywood, FLNYU Langone Health· New York, NY

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