Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Kleb4V low 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...