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ExPEC9V · 2 trials · 1 indication
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...
ExPEC9V is an investigational 9-valent vaccine being studied for the prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED), a serious infection caused by E. coli. It is being evaluated in adults aged 60 years and older with a history of urinary tract infection in the past 2 years, as well as in adults aged 65 years or older.
ExPEC9V is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The vaccine is currently in Phase 3 clinical development for the prevention of Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED).
ExPEC9V is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, evaluating the vaccine's safety and efficacy in preventing Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) in older adult populations.
ExPEC9V has completed two Phase 3 clinical trials. The first, NCT04899336, enrolled 17,797 adults aged 60 years and older with a history of urinary tract infection. The second, NCT06134804, enrolled 959 adults aged 65 years or older and studied co-administration with a high-dose quadrivalent influenza vaccine. Both trials were randomized, double-blind, and controlled.
ExPEC9V is a 9-valent vaccine designed to target multiple strains of Extraintestinal Pathogenic Escherichia Coli (ExPEC). By presenting nine different E. coli antigens to the immune system, it aims to stimulate a protective immune response against the bacteria that cause Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED).
No, ExPEC9V is a vaccine, not a monoclonal antibody. It is classified as a 9-valent vaccine, meaning it contains components from nine different E. coli strains to elicit an immune response. This distinguishes it from monoclonal antibody therapies, which are laboratory-made proteins that target specific antigens.