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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-64
SponsorGlaxoSmithKline

About this trial

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.

Eligibility criteria

Qualifiers

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.

has practiced adequate contraception for 1 month prior to study intervention administration, and

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Candidate UTI vaccine low dose formulation 1
  • Candidate UTI vaccine low dose formulation 2
  • Candidate UTI vaccine medium dose formulation 1
  • Candidate UTI vaccine medium dose formulation 2
  • Candidate UTI vaccine high dose formulation 1
  • Candidate UTI vaccine high dose formulation 2
  • Candidate UTI vaccine HTD formulation 2
  • Placebo

Treatment groups

448 Participants
are divided into 8 treatment groups

8

Treatment groups

See each treatment group below.

Sponsors and collaborators