Phase 3 ExPEC9V vaccine trial for prevention of invasive extraintestinal pathogenic E. coli disease in older adults with prior UTI

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