Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Influenza Monovalent Whole virus · 1 trial · 1 indication
Geometric mean titers (GMTs) of serum antibodies
| Arm | Type | Description |
|---|---|---|
| H5N1 Formulation 1 Group | EXPERIMENTAL | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval |
| H5N1 Formulation 2 Group | EXPERIMENTAL | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval |
| H5N1 Formulation 3 Group | EXPERIMENTAL | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval |
| H5N1 Formulation 4 Group | EXPERIMENTAL | Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval |
| H5N1 Formulation 5 Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval |
| H5N1 Formulation 6 Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval |
| H5N1 Formulation 7 Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval |
| H5N1 Formulation 8 Group | ACTIVE_COMPARATOR | Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval |
| Name | Type | Description |
|---|---|---|
| Influenza Monovalent Whole virus (H5N1) adjuvanted vaccine | BIOLOGICAL | 2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21 |
| Influenza Monovalent Whole virus (H5N1) | BIOLOGICAL | 2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21 |
Inclusion criteria: * A male or female between, and including, 18 and 60 years of age at the time of the first vaccination. * Healthy subjects as established by medical history and clinical examination before entering into the study. * If the subject is female, she must be of non-childbearing poten...
Influenza Monovalent Whole virus is an investigational vaccine being studied for the prevention of influenza. It was evaluated in a Phase 1 clinical trial in adults 18 years of age and older. The vaccine is designed to target the H5N1 influenza strain, as indicated by the trial title.
Influenza Monovalent Whole virus is being developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The company conducted a Phase 1 clinical trial to evaluate the safety and immunogenicity of the vaccine.
Influenza Monovalent Whole virus is in Phase 1 clinical development. The Phase 1 trial has been completed, and the vaccine remains investigational, meaning it has not yet been approved by regulatory authorities. Further clinical development would be required before any potential approval.
Influenza Monovalent Whole virus has been studied in one completed Phase 1 clinical trial, identified as NCT00309647. The trial enrolled 400 participants in Germany and evaluated the safety and immunogenicity of pandemic monovalent (H5N1) influenza vaccines with a whole virus formulation in adults aged 18 years and older.
Influenza Monovalent Whole virus refers to the vaccine formulation studied in the clinical trial NCT00309647, which evaluated pandemic monovalent (H5N1) influenza vaccines. The trial specifically tested a whole virus formulation, which is a type of influenza vaccine designed to protect against the H5N1 strain.