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New vaccine trial aims to shield toddlers from pneumococcal disease

NCT ID NCT06531538

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

Jul 2024

Finished

Feb 2026

Lead sponsor

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Atrium Health - Strive Vaccine Research Clinic

    Charlotte, North Carolina, 28207, United States

  • Atrium Health-Matthews

    Matthews, North Carolina, 28105, United States

  • Atrium Health-Myers Park

    Charlotte, North Carolina, 28207, United States

  • BRCR Global Puerto Rico

    San Juan, 00907-1509, Puerto Rico

  • BRCR Medical Center - Ponce

    Ponce, 00717, Puerto Rico

  • Bio-Medical Research LLC

    Miami, Florida, 33144, United States

  • CMRC Headlands, LLC

    San Juan, 00918, Puerto Rico

  • Carolina Family Care

    Charleston, South Carolina, 29414, United States

  • Carolina Family Care

    Summerville, South Carolina, 29486, United States

  • DM Clinical Research - Kool Kids Pediatrics

    Houston, Texas, 77065, United States

  • Duke University

    Durham, North Carolina, 27705, United States

  • Duke Vaccine and Trials Unit

    Durham, North Carolina, 27703, United States

  • Durham Pediatrics at North Duke Street

    Durham, North Carolina, 27704, United States

  • Emerson Clinical Research Institute

    Washington D.C., District of Columbia, 20009, United States

  • Holston Medical Group

    Kingsport, Tennessee, 37660, United States

  • Javara - Privia Medical Group Georgia - Fayetteville

    Fayetteville, Georgia, 30214, United States

  • Javara - Privia Medical Group North Texas - Dallas

    Dallas, Texas, 75230, United States

  • Kool Kids Pediatrics

    Houston, Texas, 77065, United States

  • Louisiana State University Health Sciences Shreveport

    Shreveport, Louisiana, 71103, United States

  • Louisiana State University Health Sciences Shreveport - Fairfield avenue

    Shreveport, Louisiana, 71101, United States

  • MUSC Children's Health

    Charleston, South Carolina, 29414, United States

  • MUSC Children's Health

    Summerville, South Carolina, 29486, United States

  • Mercury Clinical Research - Houston

    Houston, Texas, 77054, United States

  • Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic

    Tomball, Texas, 77375, United States

  • Mercury Clinical Research - Pediatric Associates

    Houston, Texas, 77087, United States

  • Mercury Clinical Research - Sunrise Pediatrics

    Houston, Texas, 77077, United States

  • Oak Cliff Research Company, LLC

    Dallas, Texas, 75252, United States

  • Oak Cliff Research Company, LLC

    Dallas, Texas, 75287, United States

  • Ochsner/LSU Health Ambulatory Care Center

    Shreveport, Louisiana, 71103, United States

  • Pediatric Clinical Trials of Tennessee, LLC

    Tullahoma, Tennessee, 37388, United States

  • Ponce Medical School Foundation Inc.

    Ponce, 00716, Puerto Rico

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291, United States

  • Senders Pediatrics

    South Euclid, Ohio, 44121, United States

  • Tekton Research, LLC.

    Chamblee, Georgia, 30341, United States

  • The Iowa Clinic

    Ankeny, Iowa, 50023, United States

  • The Pediatric Center

    Columbia, Maryland, 21045, United States

  • University of Maryland, Baltimore - Institutional Review Board

    Baltimore, Maryland, 21201, United States

  • University of Maryland, Baltimore, Center for Vaccine Development and Global Health

    Baltimore, Maryland, 21201, United States

  • University of Texas Medical Branch

    League City, Texas, 77573, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.