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PG4

Phase 3

Pneumococcal Disease | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Jul 9, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials5
Total Enrollment7,660
FDA Designations
No designations recorded
Clinical trial landscape

PG4 · 5 trials · 1 indication

Phase 3 3Phase 2 2
NCT07660198Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and AdolescentsPneumococcal Disease
RECRUITING1,200 Analytics
NCT07629440A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.Pneumococcal Disease
RECRUITING3,230 Analytics
NCT07573462A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy InfantsPneumococcal Disease
RECRUITING2,400 Analytics
PHASE3RECRUITING
Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease
NCT076601981,200
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PHASE3RECRUITING
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.
Pneumococcal Disease
NCT076294403,230
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PHASE3RECRUITING
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
NCT075734622,400
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Study Endpoints
Primary Endpoints
Percentage of Participants With Local Reactions Within 7 Days After Vaccination
Within 7 days after Vaccination
Percentage of Participants With Systemic Events Within 7 Days after Vaccination
Within 7 days after Vaccination
Percentage of Participants With Adverse Events (AEs)
From Vaccination to 1 month after Vaccination
Percentage of Participants With Serious Adverse Events (SAEs)
From Vaccination to 6 months after Vaccination
GMCs of serotype-specific IgG concentrations
1 month after vaccination
GMTs of serotype-specific OPA titers
1 month after vaccination
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
Percentage of participants with predefined serotype-specific IgG concentrations
1 month after vaccination
IgG GMFRs
1 month after vaccination
Percentage of participants with a ≥4-fold rise in serotype-specific OPA titers
before to 1 month after vaccination
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION
Treatment Arms
ArmTypeDescription
PG4 (intramuscular)EXPERIMENTALMultivalent Pneumococcal vaccine
20-valent pneumococcal conjugate vaccine (20vPnC) (intramuscular)ACTIVE_COMPARATOR20-valent pneumococcal conjugate vaccine (20vPnC)
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 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 Range15 Months to 17 Years
SexALL
Healthy VolunteersYes
Study Sites44

Inclusion Criteria: Cohort 1 (Participants ≥15 Months to \<2 Years of Age) Healthy toddlers and children ≥15 months to \<2 years of age with documentation of prior receipt of PCV. Cohort 2 (Participants ≥2 Years to \<5 Years of Age) Healthy toddlers and children ≥2 years to \<5 years of age with d...

Countries:United StatesPuerto RicoJapanCanada
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Recent Changes (Last 90 Days)
LOWJul 9, 2026NCT07660198lastUpdatePostDate: changed
LOWJul 9, 2026NCT07629440lastUpdatePostDate: changed
LOWJul 9, 2026NCT07573462lastUpdatePostDate: changed
LOWJul 9, 2026NCT06524414lastUpdatePostDate: changed
LOWJul 9, 2026NCT07660198lastUpdatePostDate: changed
LOWJul 9, 2026NCT07629440lastUpdatePostDate: changed
LOWJul 9, 2026NCT07573462lastUpdatePostDate: changed
LOWJul 9, 2026NCT06524414lastUpdatePostDate: changed
LOWJun 24, 2026NCT07660198primaryCompletionDate: changed
LOWJun 24, 2026NCT07660198primaryCompletionDate: changed
LOWJun 22, 2026NCT07660198NEW_TRIAL: changed
LOWJun 22, 2026NCT07660198NEW_TRIAL: changed
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