New vaccine trial aims to shield toddlers from pneumococcal disease
NCT ID NCT06531538
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new pneumococcal vaccine in 225 healthy toddlers aged 12 to 15 months. The goal was to check safety and how well the vaccine triggers an immune response. Participants received either one or two doses and were monitored for side effects and antibody levels over several months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- multivalent pneumococcal conjugate vaccine
- What this could lead to
- If successful, this could lead to a vaccine that better protects toddlers against pneumococcal disease, reducing infections like pneumonia and meningitis.
- What could go wrong
- This is an early Phase 2 trial with only 225 participants, so results may not confirm broad effectiveness or safety. Side effects like injection site pain or fever are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
225 people
The number who actually took part.
- Started
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Jul 2024
- Finished
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Feb 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
12 to 15 months
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female toddlers ≥12 to ≤15 months of age at the time of consent. * 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: * History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Atrium Health - Strive Vaccine Research Clinic
Charlotte, North Carolina, 28207, United States
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Atrium Health-Matthews
Matthews, North Carolina, 28105, United States
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Atrium Health-Myers Park
Charlotte, North Carolina, 28207, United States
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BRCR Global Puerto Rico
San Juan, 00907-1509, Puerto Rico
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BRCR Medical Center - Ponce
Ponce, 00717, Puerto Rico
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Bio-Medical Research LLC
Miami, Florida, 33144, United States
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CMRC Headlands, LLC
San Juan, 00918, Puerto Rico
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Carolina Family Care
Charleston, South Carolina, 29414, United States
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Carolina Family Care
Summerville, South Carolina, 29486, United States
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DM Clinical Research - Kool Kids Pediatrics
Houston, Texas, 77065, United States
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Duke University
Durham, North Carolina, 27705, United States
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Duke Vaccine and Trials Unit
Durham, North Carolina, 27703, United States
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Durham Pediatrics at North Duke Street
Durham, North Carolina, 27704, United States
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Emerson Clinical Research Institute
Washington D.C., District of Columbia, 20009, United States
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Holston Medical Group
Kingsport, Tennessee, 37660, United States
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Javara - Privia Medical Group Georgia - Fayetteville
Fayetteville, Georgia, 30214, United States
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Javara - Privia Medical Group North Texas - Dallas
Dallas, Texas, 75230, United States
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Kool Kids Pediatrics
Houston, Texas, 77065, United States
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Louisiana State University Health Sciences Shreveport
Shreveport, Louisiana, 71103, United States
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Louisiana State University Health Sciences Shreveport - Fairfield avenue
Shreveport, Louisiana, 71101, United States
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MUSC Children's Health
Charleston, South Carolina, 29414, United States
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MUSC Children's Health
Summerville, South Carolina, 29486, United States
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Mercury Clinical Research - Houston
Houston, Texas, 77054, United States
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Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic
Tomball, Texas, 77375, United States
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Mercury Clinical Research - Pediatric Associates
Houston, Texas, 77087, United States
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Mercury Clinical Research - Sunrise Pediatrics
Houston, Texas, 77077, United States
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Oak Cliff Research Company, LLC
Dallas, Texas, 75252, United States
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Oak Cliff Research Company, LLC
Dallas, Texas, 75287, United States
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Ochsner/LSU Health Ambulatory Care Center
Shreveport, Louisiana, 71103, United States
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Pediatric Clinical Trials of Tennessee, LLC
Tullahoma, Tennessee, 37388, United States
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Ponce Medical School Foundation Inc.
Ponce, 00716, Puerto Rico
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Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, Georgia, 30291, United States
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Senders Pediatrics
South Euclid, Ohio, 44121, United States
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Tekton Research, LLC.
Chamblee, Georgia, 30341, United States
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The Iowa Clinic
Ankeny, Iowa, 50023, United States
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The Pediatric Center
Columbia, Maryland, 21045, United States
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University of Maryland, Baltimore - Institutional Review Board
Baltimore, Maryland, 21201, United States
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University of Maryland, Baltimore, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201, United States
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University of Texas Medical Branch
League City, Texas, 77573, United States
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Other studies related to the condition(s) this trial covers.
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