Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PG4 vaccine in Buffer 1 with low dose PA-001 · 1 trial · 1 indication
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 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 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 |
Key Inclusion Criteria: * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. * Participants either with no history of ever receiving a pneumococcal vaccine or who have r...
The PG4 vaccine in Buffer 1 with low dose PA-001 is an investigational vaccine being studied for the prevention of Streptococcus pneumoniae infection. It is currently in Phase 1 clinical development for this infectious disease indication.
The PG4 vaccine in Buffer 1 with low dose PA-001 is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting a Phase 1 clinical trial to evaluate this investigational pneumococcal vaccine.
The PG4 vaccine in Buffer 1 with low dose PA-001 is in Phase 1 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. The ongoing Phase 1 trial is active but not recruiting participants.
The PG4 vaccine in Buffer 1 with low dose PA-001 is being evaluated in a Phase 1 clinical trial with the identifier NCT07086677. This randomized, double-blind, active-controlled study is enrolling 380 adults aged 65 years and older in the United States.
No, the PG4 vaccine in Buffer 1 with low dose PA-001 is classified as a vaccine, not a monoclonal antibody. It is being developed to prevent Streptococcus pneumoniae infection and is currently in Phase 1 clinical trials.