Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Kleb4V target dose · 1 trial · 1 indication
Occurrence, severity and relationship of solicited local and general AEs (Adverse Events)
Occurrence, severity and relationship of unsolicited AEs
Occurrence, severity and relationship of medically relevant AEs, AESIs (Adverse Events of Special Interest) and SAEs (Serious Adverse Events)
For each active group vs. placebo: Comparison of geometric mean titers (GMTs) of serum IgG against the four K. pneumoniae O-serotypes included in Kleb4V.
| Arm | Type | Description |
|---|---|---|
| Kleb4V target dose | EXPERIMENTAL | Study participants receive 2 target doses of the non-adjuvanted investigational product 2 months apart. |
| Kleb4V target dose + AS03 | EXPERIMENTAL | Study participants receive 2 target doses of the adjuvanted investigational product 2 months apart. |
| Kleb4V low dose | EXPERIMENTAL | Study participants receive 2 low doses of the non-adjuvanted investigational product 2 months apart. |
| Kleb4V low dose + AS03 | EXPERIMENTAL | Study participants receive 2 low doses of the adjuvanted investigational product 2 months apart. |
| Placebo (Diluent) | PLACEBO_COMPARATOR | Study participants receive 2 doses of the Placebo 2 months apart. |
| Name | Type | Description |
|---|---|---|
| Kleb4V target dose | BIOLOGICAL | Two doses of the non-adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart |
| Kleb4V target dose + AS03 | BIOLOGICAL | Two doses of the adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart |
| Kleb4V low dose | BIOLOGICAL | Two doses of the non-adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart |
| Kleb4V low dose + AS03 | BIOLOGICAL | Two doses of the adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart |
| Placebo | BIOLOGICAL | Two doses of the Placebo will be administered intramuscularly 2 months apart |
Inclusion Criteria: 1. Good general health by medical history, laboratory findings and physical examination before receiving vaccination as judged by the investigator (subjects with a minor controlled illness, such as mild controlled hypertension, asthma or COPD (Chronic Obstructive Pulmonary Disea...
Kleb4V target dose is an investigational monoclonal antibody being developed by GSK plc (GSK) for the prevention or treatment of Klebsiella pneumoniae infection. It is currently in Phase 1 clinical development. The drug is being studied in a completed Phase 1 trial that evaluated its safety and immunogenicity.
Kleb4V target dose is being developed for Klebsiella pneumoniae infection, a bacterial infection that can cause pneumonia, bloodstream infections, and other serious conditions. The drug is intended to address this infectious disease through its monoclonal antibody mechanism, though specific efficacy data has not been disclosed.
Kleb4V target dose is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker GSK. GSK is conducting clinical research on this investigational monoclonal antibody for Klebsiella pneumoniae infection.
Kleb4V target dose is in Phase 1 clinical development. The drug is investigational and has not been approved by regulatory authorities. A Phase 1 clinical trial has been completed, but the drug remains in early-stage clinical development and is not yet available for commercial use.
Kleb4V target dose has been studied in one clinical trial, NCT04959344, titled "Safety and Immunogenicity of a Klebsiella Pneumoniae Tetravalent Bioconjugate Vaccine (Kleb4V)". This Phase 1 trial was completed and enrolled 166 participants in Germany. The trial was randomized, double-blind, and placebo-controlled, and included healthy volunteers aged 18 years and older.