A Study to Learn About How a New Pneumococcal Vaccine Works in Children
NCT ID: NCT06531538
Last Updated: 2025-07-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
225 participants
INTERVENTIONAL
2024-07-30
2026-02-16
Brief Summary
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Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group.
At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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PG4 1-Dose Group
Participants to receive a single injection of Multivalent Pneumococcal Vaccine
PG4
Multivalent pneumococcal conjugate vaccine.
PG4 2-Dose Group
Participants to receive two injections of Multivalent Pneumococcal Vaccine
PG4
Multivalent pneumococcal conjugate vaccine.
20-valent pneumococcal conjugate vaccine (20vPnC)
Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC).
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Interventions
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PG4
Multivalent pneumococcal conjugate vaccine.
20-valent pneumococcal conjugate vaccine (20vPnC)
20-valent pneumococcal conjugate vaccine (20vPnC)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
* Have received 3 infant doses of 20vPnC with the last dose administered \>56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
Exclusion Criteria
* Major known congenital malformation or serious chronic disorder.
* Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Previous vaccination with any licensed or investigational pneumococcal vaccine (other than 20vPnC) or planned receipt during study participation.
12 Months
15 Months
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Bio-Medical Research LLC
Miami, Florida, United States
Riveldi Biomedical Research and Associates - Miami Lakes
Miami Lakes, Florida, United States
Tekton Research, LLC.
Chamblee, Georgia, United States
Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, United States
Clinical Research Prime
Idaho Falls, Idaho, United States
Clinical Research Prime Rexburg
Rexburg, Idaho, United States
The Iowa Clinic
Ankeny, Iowa, United States
All Children Pediatrics
Louisville, Kentucky, United States
Bluegrass Clinical Research, Inc.
Louisville, Kentucky, United States
Louisiana State University Health Sciences Shreveport - Fairfield avenue
Shreveport, Louisiana, United States
Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, United States
Ochsner/LSU Health Ambulatory Care Center
Shreveport, Louisiana, United States
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, United States
University of Maryland, Baltimore
Baltimore, Maryland, United States
The Pediatric Center
Columbia, Maryland, United States
The Pediatric Center of Frederick
Frederick, Maryland, United States
Child Health Care Associates
East Syracuse, New York, United States
Atrium Health - Strive Vaccine Research Clinic
Charlotte, North Carolina, United States
Atrium Health-Myers Park
Charlotte, North Carolina, United States
Duke Vaccine and Trials Unit
Durham, North Carolina, United States
Durham Pediatrics at North Duke Street
Durham, North Carolina, United States
Atrium Health-Matthews
Matthews, North Carolina, United States
Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics
Winston-Salem, North Carolina, United States
Senders Pediatrics
South Euclid, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
Allegheny Health and Wellness Pavilion
Erie, Pennsylvania, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
Holston Medical Group
Kingsport, Tennessee, United States
Pediatric Clinical Trials of Tennessee,LLc
Tullahoma, Tennessee, United States
Javara - Privia Medical Group North Texas - Dallas
Dallas, Texas, United States
Oak Cliff Research Company, LLC
Dallas, Texas, United States
Oak Cliff Research Company, LLC
Dallas, Texas, United States
PAS Research - McAllen
Edinburg, Texas, United States
Mercury Clinical Research - Houston
Houston, Texas, United States
DM Clinical Research
Houston, Texas, United States
Kool Kids Pediatrics
Houston, Texas, United States
Mercury Clinical Research - Sunrise Pediatrics
Houston, Texas, United States
Mercury Clinical Research - Pediatric Associates
Houston, Texas, United States
University of Texas Medical Branch
League City, Texas, United States
Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas, United States
Ponce Medical School Foundation Inc.
Ponce, , Puerto Rico
BRCR Medical Center - Ponce
Ponce, , Puerto Rico
BRCR Global Puerto Rico
San Juan, , Puerto Rico
Caribbean Medical Research Center
San Juan, , Puerto Rico
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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NCT06531538
Identifier Type: REGISTRY
Identifier Source: secondary_id
2025-000101-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4931010
Identifier Type: -
Identifier Source: org_study_id
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