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PG4 Multivalent Vaccine

Phase 3

Pneumococcal Disease | Monoclonal antibody | Infectious Disease |Pfizer, Inc.|Last Updated: Aug 31, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment4,670

FDA Designations

No designations recorded

Clinical trial landscape

PG4 Multivalent Vaccine · 1 trial · 1 indication

Phase 3 1
NCT07794748A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to AdultsPneumococcal Disease
NOT YET_RECRUITING4,670 Analytics
PHASE3NOT YET_RECRUITING
A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults
Pneumococcal Disease
NCT077947484,670
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Study Endpoints

Primary Endpoints

Percentage of Participants with Prespecified Local Reactions Within 7 Days After Vaccination
Within 7 days after Vaccination

Prompted local reactions after each dose

Percentage of Participants reporting Prespecified Systemic Events Within 7 Days after Vaccination
Within 7 days after Vaccination

Prompted systemic events after each dose

Percentage of Participants with Adverse Events (AEs)
From Vaccination to 1 month after Vaccination

AEs occurring from Dose 1 to 1 month after the vaccination

Percentage of Participants with Serious Adverse Events (SAEs)
From Vaccination to 6 months after Vaccination

SAEs occurring from Dose 1 to 6 months after the vaccination

OPA geometric mean ratios (GMR) between each pair of PG4 vaccine lots
1 month after Vaccination

OPA GMRs between each pair of PG4 vaccine lots at 1 month after vaccination

Secondary Endpoints

OPA Serotype-specific geometric mean titers (GMT) for PG4 vaccine serotypes
1 month after Vaccination
OPA geometric mean fold rise (GMFR) for PG4 vaccine serotypes
From before vaccination to 1 month after vaccination
Percentages of participants with a ≥4-fold rise in opsonophagocytic activity (OPA) titers
From Vaccination to 6 months after Vaccination
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
PG4 Vaccine Lot 1EXPERIMENTALMultivalent Pneumococcal Vaccine
PG4 Vaccine Lot 2EXPERIMENTALMultivalent Pneumococcal Vaccine
PG4 Vaccine Lot 3EXPERIMENTALMultivalent Pneumococcal Vaccine
20 Valent Pneumococcal Conjugate Vaccine (20vPnC)ACTIVE_COMPARATOR20 Valent Pneumococcal Conjugate Vaccine

Interventions

NameTypeDescription
PG4 Multivalent VaccineBIOLOGICALMultivalent Pneumococcal Vaccine
20 Valent Pneumococcal Conjugate Vaccine (20vPnC)BIOLOGICAL20 Valent Pneumococcal Conjugate Vaccine
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Eligibility Criteria

Age Range18 Years to 49 Years
SexALL
Healthy VolunteersYes
Study Sites25

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...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 31, 2026NCT07794748NEW_TRIAL: changed
LOWAug 31, 2026NCT07794748NEW_TRIAL: changed