Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pneumococcal vaccine Formulation 1 · 3 trials · 3 indications
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia.
Solicited injection site reactions: Pain, Erythema, and Swelling. Solicited systemic reactions: Fever (Temperature), Headache, Malaise, and Myalgia
| Arm | Type | Description |
|---|---|---|
| Vaccine Formulation 1 (Low dose) | EXPERIMENTAL | Participants will receive 2 injections of Pneumococcal Vaccine Formulation 1 (Low dose). |
| Vaccine Formulation 2 (Middle dose) | EXPERIMENTAL | Participants will receive 2 injections of Pneumococcal Vaccine Formulation 2, (Middle dose). |
| Vaccine Formulation 3 (High dose) | EXPERIMENTAL | Participants will receive 2 injections of Pneumococcal Vaccine Formulation 3, (High dose). |
| Placebo Pooled | PLACEBO_COMPARATOR | Participants who receive 2 injections of tris buffered saline |
| Pneumococcal Vaccine Formulation 1 | EXPERIMENTAL | Participants will receive an injection of pneumococcal vaccine (Formulation 1, 1 middle dose) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Formulation 2 | EXPERIMENTAL | Participants will receive an injection of Pneumococcal vaccine (Formulation 2, 2 low doses) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Formulation 3 | EXPERIMENTAL | Participants will receive an injection of pneumococcal vaccine (Formulation 3, 2 middle doses) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Formulation 4 | EXPERIMENTAL | Participants will receive an injection of pneumococcal vaccine (Formulation 4, 2 middle doses) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Formulation 5 | EXPERIMENTAL | Participants will receive an injection of pneumococcal vaccine (Formulation 5, 2 high doses) on Day 0 and Day 30, respectively. |
| Pooled placebo Group | PLACEBO_COMPARATOR | Participants will receive an injection of a placebo on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Dose 1 (Low dose) | EXPERIMENTAL | Participants will receive 2 injections of Dose 1 investigational Pneumococcal vaccine (Low dose) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Dose 2 (Middle dose) | EXPERIMENTAL | Participants will receive 2 injections of the investigational Pneumococcal vaccine (Middle dose) on Day 0 and Day 30, respectively. |
| Pneumococcal Vaccine Dose 3 (High dose) | EXPERIMENTAL | Participants will receive 2 injections of the investigational Pneumococcal vaccine (High dose) on Day 0 and Day 30, respectively. |
| Name | Type | Description |
|---|---|---|
| Pneumococcal vaccine Formulation 1 | BIOLOGICAL | 0.5 mL, Intramuscular (Low dose) |
| Pneumococcal vaccine Formulation 2 | BIOLOGICAL | 0.5 mL, Intramuscular (Middle dose) |
| Pneumococcal vaccine Formulation 3 | BIOLOGICAL | 0.5 mL, Intramuscular (High dose) |
| Placebo | BIOLOGICAL | 0.5 mL, Intramuscular |
| Pneumococcal Vaccine Formulation 4 | BIOLOGICAL | 0.5 mL, intramuscular (2 middle doses) |
| Pneumococcal Vaccine Formulation 5 | BIOLOGICAL | 0.5 mL, intramuscular (2 high doses) |
| Pneumococcal Vaccine | BIOLOGICAL | 0.5 mL, intramuscular |
Inclusion Criteria: * Aged 18 to 50 years on the day of inclusion * Informed consent form has been signed and dated * Able to attend all scheduled visits and comply with all trial procedures * Subject is healthy, as determined by medical history and physical examination * For a woman of child-beari...
Pneumococcal Vaccine High Dose is an investigational vaccine being developed for the prevention of pneumococcal infections and pneumonia. It is designed to protect against diseases caused by Streptococcus pneumoniae, including pneumococcal pneumonia. The vaccine is currently in Phase 1 clinical development and has not been approved for use.
Pneumococcal Vaccine High Dose is being developed by Sanofi, a global biopharmaceutical company. Sanofi is listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational vaccine in healthy volunteers.
Pneumococcal Vaccine High Dose is in Phase 1 clinical development. It is an investigational vaccine that has not yet been approved by regulatory authorities. The Phase 1 trials have been completed, and the vaccine is still in the early stages of clinical testing to assess its safety and immune response.
Pneumococcal Vaccine High Dose has been studied in three completed Phase 1 clinical trials: NCT01444001, NCT01444339, and NCT01444352. These trials evaluated the vaccine in healthy adults in Switzerland, with a total enrollment of 294 participants. The trials were randomized, double-blind, and placebo-controlled.
Pneumococcal Vaccine High Dose is an investigational vaccine being developed by Sanofi. It is distinct from other pneumococcal vaccines, though specific alternative names have not been provided. The vaccine is being studied for its potential to prevent pneumococcal infections and pneumonia, and it is currently in Phase 1 clinical trials.