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Phase 3 ExPEC9V vaccine in adults ≥60 years with prior urinary tract infection
jRCT2031210272Phase 3Completed
- Sponsor
- Janssen Pharmaceutical
- Start
- Sep 2021
- Modality
- Split/Subunit Vaccines → Inactivated Vaccines → Prophylactic Vaccines → Vaccines & Immunotherapeutics
01
Overview
Phase 3, randomised, double-blind trial in colibacillosis and urinary tract infection (UTI) comparing ExPEC9V vaccine with Placebo (2 arms). Primary endpoints: Number of participants with first IED event with microbiological confirmation in blood, other sterile sites, or urine, caused by ExPEC9V O-serotypes and Number of participants with first IED event with microbiological confirmation in blood or other sterile sites caused by ExPEC9V O-serotypes. Started Sep 2021; status: completed.
02
Drugs
ExPEC9V
03
Conditions
colibacillosisurinary tract infection (UTI)
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