Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Multivalent Pneumococcal Vaccine- Formulation 1 · 1 trial · 1 indication
Prespecified local reactions (redness, swelling, and pain at the injection site) after vaccination
Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) after vaccination
Adverse events occurring within 1 month after vaccination
SAEs occurring within 6 months after vaccination
Related SAEs occurring through 12 months after vaccination
| Arm | Type | Description |
|---|---|---|
| Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 1 | EXPERIMENTAL | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 1. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
| Phase 1 (Stage 1): Multivalent Pneumococcal Vaccine - Formulation 2 | EXPERIMENTAL | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 2. This is a possible candidate for continuation in Phase 2 (Stage 2, 3, and 4). |
| Phase 1 (Stage 1) and Phase 2 (Stage 2): 20-valent pneumococcal conjugate vaccine (20vPnC) | ACTIVE_COMPARATOR | Participants to receive a single injection of 20vPnC. |
| Phase 2 (Stage 3): a licensed pneumococcal comparator vaccine | ACTIVE_COMPARATOR | Participants to receive a single injection of a licensed pneumococcal comparator vaccine. |
| Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 3 | EXPERIMENTAL | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 3. |
| Phase 2 (Stage 4): Multivalent Pneumococcal Vaccine - Formulation 4 | EXPERIMENTAL | Participants to receive a single injection of Multivalent Pneumococcal Vaccine - Formulation 4. |
| Name | Type | Description |
|---|---|---|
| Multivalent Pneumococcal Vaccine - Formulation 1 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
| Multivalent Pneumococcal Vaccine - Formulation 2 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine. This is a possible candidate for continuation in Phase 2 (Stages 2, 3, and 4). |
| 20-valent pneumococcal conjugate vaccine (20vPnC) | BIOLOGICAL | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Licensed pneumococcal comparator vaccine | BIOLOGICAL | A licensed pneumococcal comparator vaccine |
| Multivalent Pneumococcal Vaccine - Formulation 3 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| Multivalent Pneumococcal Vaccine - Formulation 4 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
Inclusion Criteria: * Male or female participants ≥18 to\<50 years of age (Stage 1) and ≥50 years of age (Stage 2, Stage 3, and Stage 4) at the time of consent * Adults determined by clinical assessment to be eligible for the study, including adults with preexisting stable disease within 12 weeks b...
Multivalent Pneumococcal Vaccine- Formulation 1 is an investigational vaccine being studied for the prevention of pneumococcal disease, a bacterial infection that can cause pneumonia, meningitis, and bloodstream infections. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
Multivalent Pneumococcal Vaccine- Formulation 1 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the safety and immune response of this investigational vaccine in adults.
Multivalent Pneumococcal Vaccine- Formulation 1 is in Phase 1 clinical development. A Phase 1 trial has been completed, and the vaccine remains investigational. It has not been approved by the FDA or any other regulatory agency for commercial use.
Multivalent Pneumococcal Vaccine- Formulation 1 has one completed clinical trial, NCT06182124, titled "A Study to Learn About the Safety and Immune Response of a New Pneumococcal Vaccine in Adults." This Phase 1 study enrolled 1,363 participants in the United States and was randomized, double-blind, and active-controlled.
Multivalent Pneumococcal Vaccine- Formulation 1 is classified as a monoclonal antibody modality, though it is being developed as a vaccine to prevent pneumococcal disease. The distinction between these categories is not further detailed in the available clinical trial information.