Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pfizer · NCT07660198
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 1–17 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Interventional · Phase 3
- Target enrollment
- 1200
- US sites recruiting
- 62
- Study start
- June 15, 2026
- Record last updated
- October 26, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: PG4; 20-valent pneumococcal conjugate vaccine (20vPnC)
Conditions: Pneumococcal Disease
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
Cohort 1 (Participants ≥15 Months to \<2 Years of Age) Healthy toddlers and children ≥15 months to \<2 years of age with documentation of prior receipt of PCV.
Cohort 2 (Participants ≥2 Years to \<5 Years of Age) Healthy toddlers and children ≥2 years to \<5 years of age with documentation of prior receipt of PCV if applicable.
Cohort 3 (Participants ≥5 Years to \<18 Years of Age) Healthy children ≥5 years to \<18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control.
Exclusion Criteria
All Cohorts (Participants ≥15 Months to \<18 Years of Age)
Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial
Recruiting US locations
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
Birmingham, AL 35205
UAB Child Health Research Unit (CHRU)
Birmingham, AL 35233
Lakeview Clinical Research, LLC
Guntersville, AL 35976
Apex Research Group
Fair Oaks, CA 95628
Orange County Research Institute
Ontario, CA 91762
Children's Hospital Colorado
Aurora, CO 80045
Riveldi and Associates
Miami Lakes, FL 33014
Indago Research & Health Center, Inc
Miami Lakes, FL 33016
South Tampa Center for Advanced Healthcare- USF Health
Tampa, FL 33606
USF Health
Tampa, FL 33606
USF Health Department of Pediatrics The Chalsty Clinics at the Curran Children's Health Center (CMS)
Tampa, FL 33612
Children's Health Center
Tampa, FL 33617
Medical Research Partners
Ammon, ID 83406
Bingham Memorial Hospital
Blackfoot, ID 83221
ASR, LLC
Boise, ID 83702
Kentucky Pediatric/ Adult Research
Bardstown, KY 40004
Avacare
Covington, LA 70433
Velocity Clinical Research, Lafayette
Lafayette, LA 70508
LSU Health Shreveport Clinical Trials Office
Shreveport, LA 71101
Ochsner/LSU Health Shreveport - Progressive Pediatrics
Shreveport, LA 71101
Ochsner LSU Health Shreveport Ambulatory Care Center
Shreveport, LA 71103
Ochsner/LSU Health Shreveport Academic Medical Center
Shreveport, LA 71103
Pediatric Associates of Fall River
Fall River, MA 02721
Michigan Center of Medical Research
Bingham Farms, MI 48025
Clinical Research Institute, Inc.
Minneapolis, MN 55402
Midwest Children's Health Research Institute
Lincoln, NE 68504
Midwest Children's Health Research Institute
Lincoln, NE 68505
Midwest Children's Health Research Institute
Lincoln, NE 68516
Midwest Children's Health Research Institute
Lincoln, NE 68522
Child Health Care Associates
East Syracuse, NY 13057
Corning Center for Clinical Research
Horseheads, NY 14845
University of Rochester Medical Center
Rochester, NY 14642
Cincinnati Children's Hospital Medical Center Investigational Drug Services
Cincinnati, OH 45206
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, OH 45206
Pediatric Associates of Mt. Carmel
Cincinnati, OH 45245
Dayton Clinical Research
Dayton, OH 45409
Senders Pediatrics
South Euclid, OH 44121
Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks
Simpsonville, SC 29681
Pediatric Clinical Trials of Tennessee, LLC
Tullahoma, TN 37388
South Texas Clinical Research
Corpus Christi, TX 78404
Driscoll Children's Hosptial
Corpus Christi, TX 78411
HG Pediatrics/Chemidox TX LLC
Houston, TX 77008
Mercury Clinical Research (Administrative Office)
Houston, TX 77054
Mercury Clinical Research - Administrative Office
Houston, TX 77054
Kool Kids Pediatrics
Houston, TX 77065
RTX Clinical Research
Houston, TX 77074
Mercury Clinical Research - Sunrise Pediatrics
Houston, TX 77077
Mercury Clinical Research - MD Kids Pediatrics
Houston, TX 77087
Neutra Life Sciences
Houston, TX 77402
University of Texas Medical Branch,
League City, TX 77573
Prime Clinical Research Inc.
Lewisville, TX 75067
Prime Clinical Research Inc.
Mansfield, TX 76063
Pediatric Center- Neutra Life Sciences
Richmond, TX 77469
Sun Research Institute
San Antonio, TX 78215
Victoria Clinical Research Group
Victoria, TX 77901
Tanner Clinic - Layton Parkway
Layton, UT 84041
Tanner Clinic
Layton, UT 84041
AMR Clinical
Provo, UT 84604
AMR Clinical
Syracuse, UT 84075
Velocity Clinical Research, Salt Lake City
West Jordan, UT 84088
+ 2 more on the official record.
Study contacts (from the official record)
- Pfizer CT.gov Call Center · 1-800-718-1021 · ClinicalTrials.gov_Inquiries@pfizer.com
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