Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PhtD vaccine with/without adjuvant · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| PhtD Group 1 | EXPERIMENTAL | Subjects will receive PhtD vaccine formulation 1 without any adjuvant. |
| PhtD Group 2 | EXPERIMENTAL | Subjects will receive adjuvanted PhtD vaccine formulation 2. |
| PhtD Group 3 | EXPERIMENTAL | Subjects will receive adjuvanted PhtD vaccine formulation 3. |
| PhtD Group 4 | EXPERIMENTAL | Subjects will receive adjuvanted PhtD vaccine formulation 4. |
| PhtD Group 5 | EXPERIMENTAL | Subjects will receive adjuvanted PhtD vaccine formulation 5. |
| 23 PPV Group | ACTIVE_COMPARATOR | Subjects will receive the Pneumovax 23TM vaccine and NaCl. |
| Name | Type | Description |
|---|---|---|
| PhtD vaccine with/without adjuvant | BIOLOGICAL | Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2. |
| Pneumovax 23TM | BIOLOGICAL | One dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0. |
| NaCl | BIOLOGICAL | One dose administered intramuscularly in the deltoid region of the right arm at month 2. |
Inclusion Criteria: * Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study. * A male or female between, and including, 18 and 45 years at the time of the first vaccination. * Written informed consent obtained from the subject. * Fr...
The PhtD vaccine with or without adjuvant is an investigational pneumococcal vaccine developed by GSK plc. It is designed to prevent pneumococcal disease and was studied in healthy adults. It is a protein-based vaccine that can be given with or without an adjuvant, a component added to boost the immune response.
The PhtD vaccine with or without adjuvant is being developed for the prevention of pneumococcal disease. Pneumococcal disease refers to infections caused by Streptococcus pneumoniae bacteria. The vaccine was evaluated in a Phase 1 study in healthy adults aged 18 years and older in Belgium.
The PhtD vaccine with or without adjuvant is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor of the clinical program evaluating this pneumococcal protein vaccine candidate.
The PhtD vaccine with or without adjuvant is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 trial has been completed, and no trials are currently active.
The PhtD vaccine with or without adjuvant has been studied in one completed Phase 1 trial, NCT01767402. The trial was titled Study to Evaluate Safety, Reactogenicity and Immunogenicity of the Pneumococcal Protein PhtD Vaccine in Healthy Adults. It enrolled 150 participants in Belgium, was randomized, and used an active-controlled design.