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

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.

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.

Sponsors & Collaborators

• GlaxoSmithKline

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

64 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-11-19

Primary Completion

2027-05-31

Completion

2027-05-31

FDA Drug

Yes

Countries

• United States
• South Africa

Study Locations