Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 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 3 | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| PG4 Vaccine Lot 2 | EXPERIMENTAL | Multivalent Pneumococcal Vaccine |
| PG4 Vaccine Lot 1 | 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 pneumococcal vaccine developed by Pfizer for the prevention of pneumococcal disease caused by Streptococcus pneumoniae. It is a multivalent vaccine candidate in Phase 3 clinical development, studied in both adults and children, including infants as young as 42 days old.
PG4 is being developed to prevent pneumococcal disease, an infectious condition caused by the bacterium Streptococcus pneumoniae. Pfizer is evaluating the vaccine across age groups, from infants to adults, in Phase 3 trials that measure safety, tolerability, and immune response to the multivalent pneumococcal conjugate vaccine.
PG4 is made by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker PFE. Pfizer is the sponsor developing the multivalent pneumococcal vaccine candidate and is running its Phase 3 clinical program across multiple countries, including the United States, Japan, Finland, Poland, and Germany.
PG4 is in Phase 3 clinical development. It is an investigational vaccine and is not yet approved for use. Pfizer has six registered trials for the program, five of which are currently active and recruiting, with one completed. The trials together have enrolled about 12,330 participants.
PG4 is being studied in Phase 3 trials including NCT07794748 in adults, NCT07660198 in children and adolescents, NCT07629440 in infants, and NCT07573462 in healthy infants across ten countries. These randomized, double-blind, active-controlled studies evaluate safety, tolerability, and immunogenicity of the pneumococcal vaccine.
Yes. PG4, the PG4 Multivalent Vaccine, and the PG4 vaccine formulations described in Buffer 1 with low dose PA-001 and in Buffer 2 all refer to the same Pfizer pneumococcal vaccine candidate. These names describe the same Phase 3 multivalent pneumococcal conjugate vaccine program.