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Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Sponsor: Pfizer
Summary
The purpose of this study is to learn about the safety of a new pneumococcal vaccine and how the new pneumococcal vaccine helps to fight against germs that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in children when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®). This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. It will also assess how the new vaccine works in comparison to the one that is currently in use. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to children. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae This study is seeking participants who: * Are children aged 15 months to 18 years. * May or may not have received any doses of pneumococcal conjugate vaccine (PCV) in the past. The study will be conducted in the United States, Puerto Rico, and other countries. Participants will be assigned to 1 of 3 groups based on age: Group 1: 15 months to less than 2 years (about 300 participants) Group 2: 2 years to less than 5 years (about 300 participants) Group 3: 5 years to less than 18 years (about 600 participants) Within each group, participants will be assigned by chance in a 2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) or 20vPnC, given in the arm or thigh. This means that for every 3 participants, about 2 will receive PG4 and about 1 will receive 20vPnC. Each participant will take part in the study for approximately 6 months. During this time, each participant will visit a clinic 2 times (visit 1 for vaccination and visit 2 to follow up) and will be contacted via telephone once (for a 6 month follow up). At the study clinic visits, participants will have their blood drawn and be asked if they have experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. During the 6-month follow-up contact, participants will be asked about any further side effects.
Official title: A PHASE 3, RANDOMIZED DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A CATCH-UP VACCINATION REGIMEN OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY CHILDREN AND ADOLESCENTS
Key Details
Gender
All
Age Range
15 Months - 17 Years
Study Type
INTERVENTIONAL
Enrollment
1200
Start Date
2026-06-15
Completion Date
2027-12-02
Last Updated
2026-06-24
Healthy Volunteers
Yes
Conditions
Interventions
PG4
Multivalent Pneumococcal Vaccine
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Locations (44)
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
Birmingham, Alabama, United States
Apex Research Group
Fair Oaks, California, United States
Orange County Research Institute
Ontario, California, United States
Riveldi and Associates
Miami Lakes, Florida, United States
Indago Research & Health Center, Inc
Miami Lakes, Florida, United States
Medical Research Partners
Ammon, Idaho, United States
Bingham Memorial Hospital
Blackfoot, Idaho, United States
ASR, LLC
Boise, Idaho, United States
Kentucky Pediatric/ Adult Research
Bardstown, Kentucky, United States
Avacare
Covington, Louisiana, United States
Velocity Clinical Research, Lafayette
Lafayette, Louisiana, United States
LSU Health Shreveport Clinical Trials Office
Shreveport, Louisiana, United States
Ochsner/LSU Health Shreveport - Progressive Pediatrics
Shreveport, Louisiana, United States
Ochsner LSU Health Shreveport Ambulatory Care Center
Shreveport, Louisiana, United States
Ochsner/LSU Health Shreveport Academic Medical Center
Shreveport, Louisiana, United States
Pediatric Associates of Fall River
Fall River, Massachusetts, United States
Michigan Center of Medical Research
Bingham Farms, Michigan, United States
Clinical Research Institute, Inc.
Minneapolis, Minnesota, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute
Lincoln, Nebraska, United States
Child Health Care Associates
East Syracuse, New York, United States
Corning Center for Clinical Research
Horseheads, New York, United States
Pediatric Associates of Mt. Carmel
Cincinnati, Ohio, United States
Dayton Clinical Research
Dayton, Ohio, United States
Senders Pediatrics
South Euclid, Ohio, United States
Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
Simpsonville, South Carolina, United States
Pediatric Clinical Trials of Tennessee, LLC
Tullahoma, Tennessee, United States
Mercury Clinical Research (Administrative Office)
Houston, Texas, United States
Kool Kids Pediatrics
Houston, Texas, United States
Mercury Clinical Research - Pediatric Associates
Houston, Texas, United States
Neutra Life Sciences
Houston, Texas, United States
Pediatric Center- Neutra Life Sciences
Richmond, Texas, United States
Sun Research Institute
San Antonio, Texas, United States
Victoria Clinical Research Group
Victoria, Texas, United States
Tanner Clinic - Layton Parkway
Layton, Utah, United States
Tanner Clinic
Layton, Utah, United States
AMR Clinical
Provo, Utah, United States
AMR Clinical
Syracuse, Utah, United States
Velocity Clinical Research, Salt Lake City
West Jordan, Utah, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Clinical Research Partners, LLC
Richmond, Virginia, United States
BRCR Global Puerto Rico
San Juan, Puerto Rico