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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: Pfizer • ClinicalTrials.gov ID: NCT07794748

Registry updated: 2026-10-14
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Description

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.

Interventions

  • PG4 Multivalent Vaccine (Biological)
    Multivalent Pneumococcal Vaccine
  • PG4 Multivalent Vaccine (Biological)
    Multivalent Pneumococcal Vaccine
  • PG4 Multivalent Vaccine (Biological)
    Multivalent Pneumococcal Vaccine
  • 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) (Biological)
    20 Valent Pneumococcal Conjugate Vaccine

Eligibility criteria

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.

Conditions

Pneumococcal Disease

Locations

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

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record