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Clinical Trials in the USA / NCT07794748
Recruiting Phase 3

A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults

NCT07794748 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2026-09-08
Last updated
2026-10-14

Condition(s) studied

Pneumococcal Disease

Investigational drug(s) / intervention(s)

PG4 Multivalent VaccinePG4 Multivalent VaccinePG4 Multivalent Vaccine20 Valent Pneumococcal Conjugate Vaccine (20vPnC) →

PG4 Multivalent Vaccine: Multivalent Pneumococcal Vaccine

PG4 Multivalent Vaccine: Multivalent Pneumococcal Vaccine

PG4 Multivalent Vaccine: Multivalent Pneumococcal Vaccine

20 Valent Pneumococcal Conjugate Vaccine (20vPnC): 20 Valent Pneumococcal Conjugate Vaccine

Study summary

The purpose of this study is to provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine.

This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines.

The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC.

Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 participants, about 2 will receive either PG4 lot 1, lot 2 or lot 3 and about 1 will receive 20vPnC.

Each participant will take part in the study for approximately 6 months.

Eligibility

Sex
ALL
Min age
18 Years
Max age
49 Years
Healthy volunteers
Accepted
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 psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.

Primary outcome measure(s)

  • 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

Trial sites (37)

FacilityCityRegionStatus
Achieve Clinical Research, LLC d/b/a Accel Research Sites - Birmingham Clinical Research Unit Birmingham Alabama Recruiting
Orange County Research Center Lake Forest California Recruiting
Diablo Clinical Research, LLC dba Flourish Research Walnut Creek California Recruiting
Clinical Research Consulting Milford Connecticut Recruiting
Suncoast Research Associates Doral Florida Recruiting
Research Centers of America Hollywood Florida Recruiting
East Coast Institute for Research, LLC Jacksonville Florida Recruiting
Entrust Clinical Research Miami Florida Recruiting
Palm Springs Community Health Center Miami Lakes Florida Recruiting
Indago Research and Health Center, Inc. Miami Lakes Florida Recruiting
Innovation Medical Research, LLC Palmetto Bay Florida Recruiting
Palm Beach Research Center West Palm Beach Florida Recruiting
Javara Inc. Fayetteville Georgia Recruiting
Clinical Research Atlanta Stockbridge Georgia Recruiting
East-West Medical Research Institute Honolulu Hawaii Recruiting
DM Clinical Research Melrose Park Illinois Recruiting
Velocity Clinical Research, Sioux City Sioux City Iowa Recruiting
Henry Ford St. John Hospital - Thomas Mackey Center for Infectious Disease Research Grosse Pointe Woods Michigan Recruiting
Clinical Research Professionals Chesterfield Missouri Recruiting
Bio-Kinetic Clinical Applications, LLC dba QPS-MO Springfield Missouri Recruiting
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center Springfield Missouri Recruiting
Sundance Clinical Research, LLC St Louis Missouri Recruiting
Velocity Clinical Research, Grand Island Grand Island Nebraska Recruiting
South Jersey Infectious Disease Somers Point New Jersey Recruiting
Accellacare - Wilmington Wilmington North Carolina Recruiting
Cincinnati Children's Hospital Medical Center Investigational Drug Services Cincinnati Ohio Recruiting
Cincinnati Children's Hospital Medical Center Vaccine Research Center Cincinnati Ohio Recruiting
CTI Clinical Research Center Cincinnati Ohio Recruiting
DM Clinical Research Philadelphia Pennsylvania Recruiting
Clinical Trials of South Carolina Moncks Corner South Carolina Recruiting
TMA Headlands LLC (d/b/a Trial Management Associates) Myrtle Beach South Carolina Recruiting
Coastal Carolina Research Center, LLC North Charleston South Carolina Recruiting
SMS Clinical Research LLC Mesquite Texas Recruiting
DM Clinical Research - Sugar Land Sugar Land Texas Recruiting
DM Clinical Research Tomball Texas Recruiting
J. Lewis Research, Inc. / Foothill Family Clinic Salt Lake City Utah Recruiting
J. Lewis Research, Inc. / Foothill Family Clinic South Salt Lake City Utah Recruiting

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Other trials for the same condition

Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents Recruiting
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants. Recruiting
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants Recruiting
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age Active, not recruiting
A Study to Learn About How a New Pneumococcal Vaccine Works in Infants Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07794748 on ClinicalTrials.gov ↗ ← All trials in the USA