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PG4

Phase 3

Pneumococcal Disease | Monoclonal antibody | Other |Pfizer, Inc.|Last Updated: Jun 5, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials4
Total Enrollment6,460
FDA Designations
No designations recorded
Clinical Trials (4)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07629440A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.PHASE3 RECRUITING 3,230 — — May 29, 2026Jun 5, 2029Jun 5, 202673 United States, Japan +1
NCT07573462A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy InfantsPHASE3 RECRUITING 2,400 — — May 4, 2026Dec 30, 2028May 27, 20269 United States
NCT06531538A Study to Learn About How a New Pneumococcal Vaccine Works in ChildrenPHASE2 COMPLETED 225 — — Jul 30, 2024Feb 9, 2026Mar 11, 202639 United States, Puerto Rico
NCT06524414A Study to Learn About How a New Pneumococcal Vaccine Works in InfantsPHASE2 ACTIVE NOT_RECRUITING 605 — — Jul 25, 2024May 1, 2027Apr 28, 202667 United States, Puerto Rico
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Study Endpoints
Primary Endpoints
Percentage of participants reporting local reactions within 7 days after each dose
Day 7

Prompted local reactions after each dose

Percentage of participants reporting systemic events within 7 days after each dose
Day 7

Prompted systemic events after each dose

Percentage of participants reporting adverse events (AEs) from Dose 1 to 1 month after Dose 3
Dose 1 to 1 month after Dose 3

AEs occurring from Dose 1 to 1 month after Dose 3

Percentage of participants reporting AEs from Dose 4 to 1 month after Dose 4
Dose 4 to 1 month after Dose 4

AEs occurring from Dose 4 to 1 month after Dose 4

Percentage of participants reporting serious adverse events (SAEs)
Dose 1 to 6 months after Dose 4

SAEs occurring from Dose 1 to 6 months after Dose 4

Differences in percentages of participants with predefined pneumococcal specific immunoglobulin G (IgG) concentrations 1 month after Dose 3
1 month after Dose 3

Differences in pneumococcal immunoglobulin G (IgG) concentrations 1 month after Dose 3

Pneumococcal IgG geometric mean concentrations (GMCs) 1 month after Dose 4
1 month after Dose 4

Pneumococcal IgG GMCs 1 month after Dose 4

Percentage of participants reporting prespecified local reactions within 7 days after each dose
7 days after each dose

Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose

Percentage of participants reporting prespecified systemic events within 7 days after each dose
7 days after each dose

Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose

Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination
From signing of ICD to 1 month after last assigned vaccination

Adverse events occurring within 1 month after the last assigned vaccination

Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination
From signing of ICD to 6 months after last assigned vaccination

SAEs occurring from Dose 1 through 6 months after the last assigned vaccination

Percentage of participants reporting adverse events (AEs)
Dose 1 to 1 month after Dose 3

AEs occurring from Dose 1 to 1 month after Dose 2

Percentage of participants reporting AEs
Dose 4 to 1 month after Dose 4

AEs occurring from Dose 4 to 1 month after Dose 4

Secondary Endpoints
Pneumococcal IgG GMCs 1 month after Dose 3
1 month after Dose 3
Percentage of participants with serotype 3 specific predefined pneumococcal IgG concentrations 1 month after Dose 3
1 month after Dose 3
Pneumococcal serotype 3 IgG GMCs 1 month after Dose 4
1 month after Dose 4
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
Group 1 PG4 (intramuscular)EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 1 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)ACTIVE_COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
Group 2 PG4 (intramuscular)EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 2 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)ACTIVE_COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
Group 3 PG4 (intramuscular)EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 3 PG4 (subcutaneous)EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 3 20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)ACTIVE_COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
PG4 (intramuscular)EXPERIMENTALMultivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)ACTIVE_COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
PG4 1-Dose GroupEXPERIMENTALParticipants to receive a single injection of Multivalent Pneumococcal Vaccine
PG4 2-Dose GroupEXPERIMENTALParticipants to receive two injections of Multivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)ACTIVE_COMPARATORParticipants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC).
Group 1 PG4EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 1 20-valent pneumococcal conjugate vaccine (20vPnC)ACTIVE_COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
Group 2 PG4EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 2 20-valent pneumococcal conjugate vaccine (20vPnC)ACTIVE_COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
Group 3 PG4EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 3 20-valent pneumococcal conjugate vaccine (20vPnC)ACTIVE_COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
Group 4 PG4EXPERIMENTALMultivalent Pneumococcal Vaccine
Group 4 15-valent pneumococcal conjugate vaccine (PCV15)ACTIVE_COMPARATOR15-valent pneumococcal conjugate vaccine (PCV15)
Interventions
NameTypeDescription
PG4BIOLOGICALMultivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)BIOLOGICAL20-valent pneumococcal conjugate vaccine (20vPnC)
15-valent pneumococcal conjugate vaccine (PCV15)BIOLOGICAL15-valent pneumococcal conjugate vaccine
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Eligibility Criteria
Age Range42 Days — 211 Days
SexALL
Healthy VolunteersYes
Study Sites73

Inclusion Criteria: * infants who are 2 months of age in Group 1. * infants who are 2 to 6 months of age in Groups 2 and 3. * Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. Exclusion Criteria: * History of severe a...

Countries:United StatesJapanPuerto Rico
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07629440NEW_TRIAL: changed
LOWJun 5, 2026NCT07629440NEW_TRIAL: changed
LOWJun 5, 2026NCT07629440NEW_TRIAL: changed
LOWJun 5, 2026NCT07629440NEW_TRIAL: changed
LOWMay 28, 2026NCT07573462Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 28, 2026NCT07573462Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT06524414primaryCompletionDate: changed
LOWMay 24, 2026NCT06524414studyFirstPostDate: changed
MEDIUMMay 21, 2026NCT06531538TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT06531538TRIAL_REMOVED: changed