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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

448

Participants

Timeline

Start Date

November 19, 2024

Primary Completion Date

May 31, 2027

Study Completion Date

May 31, 2027

Conditions
Urinary Tract Infections
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.

Trial Locations (8)

2113

RECRUITING

GSK Investigational Site, Johannesburg

14609

RECRUITING

GSK Investigational Site, Rochester

66219

RECRUITING

GSK Investigational Site, Lenexa

76086

RECRUITING

GSK Investigational Site, Weatherford

98104

RECRUITING

GSK Investigational Site, Seattle

98801

RECRUITING

GSK Investigational Site, Wenatchee

07094

RECRUITING

GSK Investigational Site, Secaucus

0152

RECRUITING

GSK Investigational Site, Soshanguve

Sponsors

Lead Sponsor

All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY