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

NCT07122986
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
310
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Lead sponsor
Pfizer
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Start date
2025-08-11
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Number of sites
11
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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.
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Short title
A Study to Learn About a Vaccine Against E Coli in Healthy Adults
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Official title
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
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-05-26
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First posted
2025-08-14
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Registry last updated
2026-04-30
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Primary completion date
2028-05-26
clinicaltrials.gov
Start date
2025-08-11
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Participants
310
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Participant count basis
Estimated
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Planned participants
310
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Protocol amendments
0
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Number of sites
11
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Pfizer
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07122986
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ClinicalTrials.gov ID
NCT07122986
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Basic science
Masking
Double masking
Masked roles
Participants, Care providers
Sources for study design
clinicaltrials.gov

  1. Percentage of participants reporting prespecified local events within 7 days following each vaccination

    Timeframe: 7 days after each vaccination

    Prespecified local reactions (redness, swelling, and pain at the injection site) following each vaccination

  2. Percentage of participants reporting prespecified systemic events within 7 days following each vaccination

    Timeframe: 7 days after each vaccination

    Prespecified systemic events (fever, fatigue, headache, chills, vomiting, diarrhea, joint pain, and muscle pain) following each vaccination

  3. Percentage of participants reporting Adverse Events (AEs) from vaccination 1 through 1 month after the last dose of study intervention

    Timeframe: 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

  4. Percentage of participants reporting Medically Attended Adverse Events (MAEs) from vaccination 1 through 12 months after the last dose of study intervention

    Timeframe: 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

  5. Percentage of participants reporting Serious Adverse Events (SAEs) from vaccination 1 through 12 months after the last dose of study intervention

    Timeframe: 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

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
64 Years
Healthy volunteers
Yes

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, and clinical judgement of the investigator to be eligible for inclusion in the study.

Key Exclusion Criteria

  1. Severe adverse reaction history associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  2. Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  3. Women who are pregnant, plan to become pregnant during the study, or are breastfeeding.
Sources for eligibility
clinicaltrials.gov

  • Anaheim Clinical Trials, LLCAnaheim, United StatesRecruiting
  • Orange County Research CenterLake Forest, United StatesRecruiting
  • Diablo Clinical Research, Inc.Walnut Creek, United StatesRecruiting
  • Miami Eye InstituteHollywood, United StatesRecruiting
  • Research Centers of AmericaHollywood, United StatesRecruiting
  • NYU Langone HealthNew York, United StatesRecruiting
  • CTI Clinical Research CenterCincinnati, United StatesRecruiting
  • Senders PediatricsSouth Euclid, United StatesRecruiting
  • Alliance for Multispecialty Research, LLCKnoxville, United StatesRecruiting
  • Alliance for Multispecialty Research, LLCKnoxville, United StatesRecruiting
  • University Eye Specialists, P.C. (Ophthalmologist)Maryville, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)