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RecruitingUrinary Tract Infections

A Study on the Safety and Immune Response of a Urinary Tract Infection (UTI) Vaccine in Adults 18-64 Years of Age and Clinical Efficacy in Females 18-64 Years of Age

Eligible age

18–64 yrs

Accepts

All genders

Locations

5 states

Healthy volunteers

Yes

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About this study

The purpose of this study is to assess safety, reactogenicity, and immune response of the candidate UTI vaccine compared to placebo in adults between and including 18-64 years of age (YOA), and to perform a preliminary evaluation of clinical efficacy in females between and including 18-64 YOA.

Sponsor: GlaxoSmithKline

You may qualify if…

  • Participants, who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the participant prior to performance of any study-specific procedure.
  • Female participants of non-childbearing potential may be enrolled in the clinical study.
  • Female participants of childbearing potential may be enrolled in the clinical study, if the participant:
  • has practiced adequate contraception for 1 month prior to study intervention administration, and
  • has a negative pregnancy test on the day of study intervention administration, and
  • has agreed to continue adequate contraception during the entire treatment period and for at least 1 month after completion of the study intervention administration series.
  • Blood sample for simultaneous follicle stimulating hormone (FSH) and estradiol levels may be collected.

You may not qualify if…

  • Medical conditions:
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention(s).
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Hypersensitivity to latex.
  • History of pIMD.
  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • History of endocrinologic, hematologic, metabolic, urologic, dermatologic, or gastrointestinal conditions that, in the opinion of the investigator, places the participant at unacceptable risk or would make adhering to study procedures for the duration of the study difficult.
  • Recurrent history or uncontrolled neurological disorders or any neuroinflammatory (including, but not limited to demyelinating disorders, encephalitis or myelitis of any origin), congenital neurological conditions, encephalopathies, or seizures.

Where it's recruiting

Kansas

Lenexa

New Jersey

Secaucus

New York

Rochester

Texas

Weatherford

Washington

Seattle · Wenatchee

Source: ClinicalTrials.gov · NCT06702449 · last updated 2026-04-21