Trial intelligence / Profile preview

Phase 3 study of ExPEC9V vaccine to prevent invasive extraintestinal pathogenic E. coli disease in adults aged 60 years and older with prior urinary tract infection

NL-OMON58974Phase 3Completed

Sponsor
Janssen Pharmaceutical
Start
May 2022
Modality
Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
Countries
1
01

Overview

Phase 3, randomised, double-blind trial in invasive extraintestinal pathogenic Escherichia coli disease (IED), urinary tract infection (UTI) and pyelonephritis comparing ExPEC9V with Placebo (2 arms). Primary endpoint: First IED event caused by ExPEC9V O-serotypes from blood or other sterile sites. Started May 2022; status: completed.

02

Drugs

ExPEC9V
03

Conditions

invasive extraintestinal pathogenic Escherichia coli disease (IED)urinary tract infection (UTI)pyelonephritis

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