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RECRUITING
NCT06702449
PHASE1/PHASE2

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

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

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.

Official title: A Seamless Phase 1/2, Observer-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Safety and Immunogenicity of a UTI Vaccine When Administered to Adults 18 Through 64 Years of Age and Clinical Efficacy When Administered to Females 18 Through 64 Years of Age

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

448

Start Date

2024-11-19

Completion Date

2027-05-31

Last Updated

2025-08-07

Healthy Volunteers

Yes

Interventions

COMBINATION_PRODUCT

Candidate UTI vaccine low dose formulation 1

Candidate UTI vaccine low dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine low dose formulation 2

Candidate UTI vaccine low dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine medium dose formulation 1

Candidate UTI vaccine medium dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine medium dose formulation 2

Candidate UTI vaccine medium dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine high dose formulation 1

Candidate UTI vaccine high dose formulation 1 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine high dose formulation 2

Candidate UTI vaccine high dose formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Candidate UTI vaccine HTD formulation 2

Candidate UTI vaccine HTD formulation 2 administered intramuscularly according to a 0, 2 months administration schedule.

COMBINATION_PRODUCT

Placebo

Placebo administered intramuscularly according to a 0, 2 months administration schedule.

Locations (8)

GSK Investigational Site

Lenexa, Kansas, United States

GSK Investigational Site

Secaucus, New Jersey, United States

GSK Investigational Site

Rochester, New York, United States

GSK Investigational Site

Weatherford, Texas, United States

GSK Investigational Site

Seattle, Washington, United States

GSK Investigational Site

Wenatchee, Washington, United States

GSK Investigational Site

Johannesburg, South Africa

GSK Investigational Site

Soshanguve, South Africa