Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as PG4 vaccine in Buffer 1 with low dose PA-001, PG4 vaccine in Buffer 2, PG4 Multivalent Vaccine
PG4 · 7 trials · 2 indications
Prompted local reactions after each dose
Prompted systemic events after each dose
AEs occurring from Dose 1 to 1 month after the vaccination
SAEs occurring from Dose 1 to 6 months after the vaccination
OPA GMRs between each pair of PG4 vaccine lots at 1 month after vaccination
Prompted local reactions after each dose
Prompted systemic events after each dose
AEs occurring from Dose 1 to 1 month after Dose 3
AEs occurring from Dose 4 to 1 month after Dose 4
SAEs occurring from Dose 1 to 6 months after Dose 4
Differences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3
Pneumococcal IgG GMCs 1 month after Dose 4
Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose
Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose
Adverse events occurring within 1 month after the last assigned vaccination
SAEs occurring from Dose 1 through 6 months after the last assigned vaccination
AEs occurring from Dose 1 to 1 month after Dose 2
AEs occurring from Dose 4 to 1 month after Dose 4
Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study.
Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study.
Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination
Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination.
Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention.
| Arm | Type | Description |
|---|---|---|
| PG4 Vaccine Lot 1 | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| PG4 Vaccine Lot 2 | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| PG4 Vaccine Lot 3 | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) | ACTIVE_COMPARATOR | 20 Valent Pneumococcal Conjugate Vaccine |
| PG4 (intramuscular) | EXPERIMENTAL | Multivalent Pneumococcal vaccine |
| 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) | ACTIVE_COMPARATOR | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Group 1 PG4 (intramuscular) | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) | ACTIVE_COMPARATOR | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Group 2 PG4 (intramuscular) | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) | ACTIVE_COMPARATOR | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Group 3 PG4 (intramuscular) | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| Group 3 PG4 (subcutaneous) | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular) | ACTIVE_COMPARATOR | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| PG4 1-Dose Group | EXPERIMENTAL | Participants to receive a single injection of Multivalent Pneumococcal Vaccine |
| PG4 2-Dose Group | EXPERIMENTAL | Participants to receive two injections of Multivalent Pneumococcal Vaccine |
| 20-valent pneumococcal conjugate vaccine (20vPnC) | ACTIVE_COMPARATOR | Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC). |
| Group 1 PG4 | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) | ACTIVE_COMPARATOR | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Group 2 PG4 | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) | ACTIVE_COMPARATOR | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Group 3 PG4 | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) | ACTIVE_COMPARATOR | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| Group 4 PG4 | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| Group 4 15-valent pneumococcal conjugate vaccine (PCV15) | ACTIVE_COMPARATOR | 15-valent pneumococcal conjugate vaccine (PCV15) |
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 1 | EXPERIMENTAL | - |
| PG4 vaccine with low dose adjuvant PA-001; dose schedule 2 | EXPERIMENTAL | - |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 1 | EXPERIMENTAL | - |
| PG4 vaccine with low dose adjuvant PA-002; dose schedule 2 | EXPERIMENTAL | - |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 1 | EXPERIMENTAL | - |
| PG4 vaccine with high dose adjuvant PA-001; dose schedule 2 | EXPERIMENTAL | - |
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 1 | EXPERIMENTAL | - |
| PG4 vaccine with high dose adjuvant PA-002; dose schedule 2 | EXPERIMENTAL | - |
| PG4 vaccine; dose schedule 1 | ACTIVE_COMPARATOR | - |
| PG4 vaccine; dose schedule 2 | ACTIVE_COMPARATOR | - |
| 20vPnC; dose schedule 1 | ACTIVE_COMPARATOR | - |
| 20vPnC; dose schedule 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| PG4 Multivalent Vaccine | BIOLOGICAL | Multivalent Pneumococcal Vaccine |
| 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) | BIOLOGICAL | 20 Valent Pneumococcal Conjugate Vaccine |
| PG4 | BIOLOGICAL | Multivalent Pneumococcal Vaccine |
| 20-valent pneumococcal conjugate vaccine (20vPnC) | BIOLOGICAL | 20-valent pneumococcal conjugate vaccine (20vPnC) |
| 15-valent pneumococcal conjugate vaccine (PCV15) | BIOLOGICAL | 15-valent pneumococcal conjugate vaccine |
| PG4 vaccine in Buffer 1 with low dose PA-001 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| PG4 in Buffer 1 with low dose PA-002 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| PG4 in Buffer 1 with high dose PA-001 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| PG4 vaccine in Buffer 1 with high dose PA-002 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| PG4 vaccine in Buffer 2 | BIOLOGICAL | Multivalent pneumococcal conjugate vaccine |
| 20-valent pneumococcal conjugate vaccine | BIOLOGICAL | (20vPnC) |
| Saline injection | BIOLOGICAL | Placebo |
Inclusion Criteria: Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age. Exclusion Criteria: Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatr...
PG4 is an investigational monoclonal antibody being developed by Pfizer for the prevention of pneumococcal disease. It is currently in Phase 3 clinical trials, with studies evaluating its use in infants and children to protect against infections caused by Streptococcus pneumoniae.
PG4 is being developed by Pfizer, Inc., a global biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The company is conducting multiple clinical trials to evaluate the safety and efficacy of this investigational monoclonal antibody for pneumococcal disease.
PG4 is currently in Phase 3 clinical development. Pfizer has completed a Phase 2 trial and is now conducting two Phase 3 studies in infants, with one additional Phase 3 trial actively recruiting participants. The drug remains investigational and has not been approved by regulatory authorities.
PG4 is being studied in several clinical trials, including NCT07573462, a Phase 3 study in healthy infants with 2,400 participants, and NCT07629440, a Phase 3 study in infants with 3,230 participants. Both are actively recruiting in the United States and other countries.
PG4 is a monoclonal antibody designed to target pneumococcal bacteria, which cause pneumococcal disease. By binding to specific components of the bacteria, it may help the immune system neutralize the pathogen and prevent infection. The exact molecular target has not been disclosed in available information.
PG4 is not a vaccine but a monoclonal antibody. While vaccines stimulate the immune system to produce antibodies, PG4 is a laboratory-made antibody that provides passive immunity. It is being studied as a potential preventive treatment for pneumococcal disease in infants and children.