A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults
Start Date
9/8/2026
Completion Date
6/7/2027
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 Criteria
Age Range: 18 years to 49 years
Interventions
PG4 Multivalent Vaccine
PG4 Multivalent Vaccine
PG4 Multivalent Vaccine
20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
Conditions
Locations
Achieve Clinical Research, LLC d/b/a Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, Alabama 35216
United States
Orange County Research Center
Lake Forest, California 92630
United States
Diablo Clinical Research, LLC dba Flourish Research
Walnut Creek, California 94598
United States
Clinical Research Consulting
Milford, Connecticut 06460
United States
Suncoast Research Associates
Doral, Florida 33172
United States
Research Centers of America
Hollywood, Florida 33024
United States
East Coast Institute for Research, LLC
Jacksonville, Florida 32216
United States
Entrust Clinical Research
Miami, Florida 33176
United States
Palm Springs Community Health Center
Miami Lakes, Florida 33014
United States
Indago Research and Health Center, Inc.
Miami Lakes, Florida 33016
United States
Innovation Medical Research, LLC
Palmetto Bay, Florida 33157
United States
Palm Beach Research Center
West Palm Beach, Florida 33409
United States
Javara Inc.
Fayetteville, Georgia 30214
United States
Clinical Research Atlanta
Stockbridge, Georgia 30281
United States
East-West Medical Research Institute
Honolulu, Hawaii 96814
United States
DM Clinical Research
Melrose Park, Illinois 60160
United States
Velocity Clinical Research, Sioux City
Sioux City, Iowa 51106
United States
Henry Ford St. John Hospital - Thomas Mackey Center for Infectious Disease Research
Grosse Pointe Woods, Michigan 48236
United States
Clinical Research Professionals
Chesterfield, Missouri 63005
United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO
Springfield, Missouri 65802
United States
Bio-Kinetic Clinical Applications, LLC dba QPS-MO-Screening and Recruitment Center
Springfield, Missouri 65807
United States
Sundance Clinical Research, LLC
St Louis, Missouri 63141
United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska 68803
United States
South Jersey Infectious Disease
Somers Point, New Jersey 08244
United States
Accellacare - Wilmington
Wilmington, North Carolina 28401
United States
Cincinnati Children's Hospital Medical Center Investigational Drug Services
Cincinnati, Ohio 45206
United States
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio 45206
United States
CTI Clinical Research Center
Cincinnati, Ohio 45212
United States
Clinical Trials of South Carolina
Moncks Corner, South Carolina 29461
United States
TMA Headlands LLC (d/b/a Trial Management Associates)
Myrtle Beach, South Carolina 29572
United States
Coastal Carolina Research Center, LLC
North Charleston, South Carolina 29405
United States
SMS Clinical Research LLC
Mesquite, Texas 75149
United States
DM Clinical Research - Sugar Land
Sugar Land, Texas 77478
United States
DM Clinical Research
Tomball, Texas 77375
United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah 84109
United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah 84121
United States