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Also known as Pneumococcal Vaccine High Dose (Formulation 1), Pneumococcal vaccine Formulation 1, Pneumococcal Vaccine, Pneumococcal vaccine (13-valent)
Pneumococcal Vaccine High Dose · 4 trials · 4 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.
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 |
|---|---|---|
| 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 |
| 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 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 |
| 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: 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...
Pneumococcal Vaccine High Dose is an investigational vaccine developed by Sanofi for the prevention of pneumococcal infections and pneumonia. It is designed to protect against Streptococcus pneumoniae, a bacterium that can cause serious infections including pneumonia. The vaccine is in Phase 1 clinical development and has been studied in healthy adults, toddlers, and infants.
Pneumococcal Vaccine High Dose is developed by Sanofi, which trades under the ticker SNY. Sanofi is the sponsor of the clinical development program for this investigational pneumococcal vaccine candidate.
Pneumococcal Vaccine High Dose is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by the FDA. All three completed trials were Phase 1 studies evaluating the vaccine in healthy volunteers.
Pneumococcal Vaccine High Dose has been evaluated in three completed Phase 1 trials. NCT01446926 studied the vaccine in healthy adults, toddlers, and infants in Bangladesh. NCT01444352 and NCT01444339 studied the vaccine in healthy adults in Switzerland. All trials are completed.
Yes, Pneumococcal Vaccine High Dose is also known as Pneumococcal Vaccine Formulation 1, Pneumococcal vaccine Formulation 1, Pneumococcal Vaccine, Pneumococcal vaccine, and Pneumococcal vaccine (13-valent). These names refer to the same investigational vaccine candidate developed by Sanofi.