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Pneumococcal Vaccine High Dose · 1 trial · 3 indications
Solicited injection site reactions: For adults: Pain, Erythema, and Swelling; Toddlers and infants: Tenderness, Erythema, Swelling. Solicited systemic reactions: For adults, Fever (Temperature), Headache, Malaise, and Myalgia; Toddlers and infants, Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Loss, Irritability.
| Arm | Type | Description |
|---|---|---|
| Group 1: Adults High Dose (Formulation 1) | EXPERIMENTAL | Adults who will receive a single injection of high dose investigational Pneumococcal vaccine |
| Group 2: Adults Placebo | PLACEBO_COMPARATOR | Adult participants who will receive an injection of placebo |
| Group 3: Toddlers High Dose (Formulation 1) | EXPERIMENTAL | Toddlers who will receive a single injection of high dose Pneumococcal vaccine |
| Group 4: Toddlers Placebo | PLACEBO_COMPARATOR | Toddlers who will receive a single injection of placebo |
| Group 5: Infants Low Dose (Formulation 2) | EXPERIMENTAL | Infants who will receive 3 injections of low dose low dose Pneumococcal vaccine |
| Group 6: Infants Placebo | PLACEBO_COMPARATOR | Infants who will receive 3 injections of placebo |
| Group 7: Infants Middle Dose (Formulation 3) | EXPERIMENTAL | Infants who will receive 3 injections of middle dose Pneumococcal vaccine |
| Group 8: Infants Middle Dose (Formulation 4) | EXPERIMENTAL | Infants who will receive 3 injections of middle dose Pneumococcal vaccine |
| Group 9: Infants Placebo | PLACEBO_COMPARATOR | Infants who will receive 3 injections of placebo |
| Group 10: Infants High Dose (Formulation 1) | EXPERIMENTAL | Infants who will receive 3 injections of high dose Pneumococcal vaccine |
| Group 11: Infants Placebo | PLACEBO_COMPARATOR | Infants who will receive 3 injections of placebo |
| Name | Type | Description |
|---|---|---|
| Pneumococcal Vaccine High Dose (Formulation 1) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Tris buffered saline (Placebo) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Pneumococcal Vaccine Low Dose (Formulation 2) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Pneumococcal Vaccine Middle Dose (Formulation 3) | BIOLOGICAL | 0.5 mL, Intramuscular |
| Pneumococcal Vaccine Middle Dose (Formulation 4) | BIOLOGICAL | 0.5 mL, Intramuscular |
Inclusion Criteria: Adults: * Aged 18 to 50 years on the day of inclusion. * Informed consent form has been signed and dated. If the subject is unable to read the informed consent form, a site-defined standard procedure will be followed to ensure subject understanding of the process and will be ma...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Tozorakimab |
| GSK plc Sponsored ADR | GSK | 3 | PHASE1 | Pn-MAPS30plus, PCV20 |
| Pfizer Inc. | PFE | 4 | - | Undisclosed |
| Sanofi SA Sponsored ADR | SNY | 1 | - | Undisclosed |
| Gilead Sciences, Inc. | GILD | 1 | - | Undisclosed |
| Grace Therapeutics, Inc. | GRCE | 1 | N/A | Undisclosed |
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.