Randomized, Double-blind, Placebo-controlled, Multicenter Phase 3 Study to Assess the Efficacy, Safety And Immunogenicity of Vaccination With ExPEC9V in the Prevention of Invasive Extraintestinal Pathogenic Escherichia coli Disease in Adults Aged 60 Years And Older with a History of Urinary Tract Infection in the Past 2 Years

Invasive Extraintestinal Pathogenic Escherichia coli Disease

First IED event, with microbiological confirmation from blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes O1, O2, O4, O6, O15, O16, O18, O25, and O75

2. All IEDs (including multiple IEDs per participant) caused by ExPEC9V O serotypes, 3. First hospitalized IED event caused by ExPEC9V O serotypes, 4. First IED event meeting criteria for sepsis caused by ExPEC9V O serotypes, 5. First bacteremic IED event caused by ExPEC9V O serotypes, 6. First pyelonephritis event caused by ExPEC9V O serotypes, 7. First UTI event caused by ExPEC9V O serotypes, 8. All UTIs (including multiple UTIs per participant) caused by ExPEC9V O serotypes, 9. First IED event caused by E. coli, 10. First pyelonephritis event caused by E. coli, 11. First UTI event caused by E. coli, 12. Antibody titers to vaccine O-serotype antigens and EPA in the Immunogenicity Subset, as determined by multiplex ECL-based immunoassay and antibody titers to vaccine O-serotype antigens, as determined by multiplex opsonophagocytic killing assay (MOPA) on Day 1 (pre-vaccination), Day 30, Day 181, Year 1, Year 2, Year 3 and Year 4, 13. Solicited local and systemic AEs (collected until 14 days postvaccination [from Day 1 to Day 15] in the Safety Subset), 14. Unsolicited AEs (collected until 29 days post-vaccination [from Day 1 to Day 30] in all participants), 15. Serious adverse events (SAEs) in all participants, 16. SF-36 and EQ-5D-5L responses at scheduled timepoints, 17. Frailty index as a measure of frailty at baseline, Year 1, Year 2, Year 3, Year 4 and at the time of an IED, 18. Medical resource utilization for IED events caused by ExPEC9V O-serotypes, 19. Medical resource utilization for UTI events (Immunogenicity Subset only) and ABP events (Immunogenicity Subset only) caused by ExPEC9V O-serotypes, 20. Hospitalization and length of stay in the hospital, including intensive care unit (ICU) hospitalization and ICU length of stay, for IED, UTI or ABP events caused by ExPEC9V O-serotypes, 21. IED-related and all-cause mortality, 1. First IED event, with microbiological confirmation from blood, other sterile sites, or urine, caused by ExPEC9V O-serotypes

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