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A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults
Sponsor: Pfizer
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.
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF 3 LOTS OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS
Key Details
Gender
All
Age Range
18 Years - 49 Years
Study Type
INTERVENTIONAL
Enrollment
4670
Start Date
2026-09-08
Completion Date
2027-06-07
Last Updated
2026-10-14
Healthy Volunteers
Yes
Conditions
Interventions
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
Locations (37)
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