Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06134804 | A Study of 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (ExPEC9V) and High-dose Quadrivalent Influenza Vaccine, With and Without Co-administration, in Adults Aged 65 Years or Older | PHASE3 | COMPLETED | 959 | — | — | Oct 24, 2023 | Jul 26, 2024 | Apr 3, 2026 | 41 | United States, Belgium +2 |
| NCT04899336 | A Study of Vaccination With 9-valent Extraintestinal Pathogenic Escherichia Coli Vaccine (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 | PHASE3 | COMPLETED | 17,935 | — | — | Jun 30, 2021 | Aug 27, 2025 | Jun 5, 2026 | 374 | United States, Australia +19 |
HI antibody titers against H1N1, H3N2, B/Victoria, and B/Yamagata Influenza vaccine strains 29 days after the administration of HD quadrivalent seasonal influenza vaccine as measured by HI assay were reported.
Antibody titers to vaccine O-serotype antigens (O1A, O2, O4, O6A, O15, O16, O18A, O25B, and O75) as determined by ECL based Immunoassay 29 days after administration of ExPEC9V on Day 1 in CoAd group and on Day 30 in Control group were reported.
Number of participants with first IED event with microbiological confirmation in blood or other sterile sites, excluding IED cases with microbiological confirmation from urine only, caused by ExPEC9V O-serotypes will be reported.
| Arm | Type | Description |
|---|---|---|
| Group 1: Coadministration (CoAd) Group | EXPERIMENTAL | Participants will receive intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) along with high-dose (HD) quadrivalent influenza vaccine, concomitantly, on Day 1 and placebo on Day 30. |
| Group 2: Control Group | EXPERIMENTAL | Participants will receive IM injection of matching placebo along with HD quadrivalent influenza vaccine, concomitantly, on Day 1 and ExPEC9V on Day 30. |
| ExPEC9V | EXPERIMENTAL | Participants will receive a single intramuscular (IM) injection of 9-valent extraintestinal pathogenic Escherichia coli vaccine (ExPEC9V) on Day 1. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive a single IM injection of matching placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| ExPEC9V | BIOLOGICAL | ExPEC9V will be administered as an IM injection. |
| Placebo | BIOLOGICAL | Placebo will be administered as an IM injection. |
| HD quadrivalent influenza vaccine | BIOLOGICAL | HD quadrivalent influenza vaccine will be administered as IM injection. |
Inclusion Criteria: * Must be medically stable at the time of vaccination such that, according to the judgment of the investigator, hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol specified follo...