A Study to Learn About How a New Pneumococcal Vaccine Works in Children
Public ClinicalTrials.gov record NCT06531538. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A PHASE 2, RANDOMIZED, PARTIALLY DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE ADMINISTERED IN HEALTHY TODDLERS 12 THROUGH 15 MONTHS OF AGE
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers. 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.
Study identification
- NCT ID
- NCT06531538
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 225 participants
Conditions and interventions
Conditions
Interventions
- PG4 Biological
- 20-valent pneumococcal conjugate vaccine (20vPnC) Biological
Biological
Eligibility (public fields only)
- Age range
- 12 Months to 15 Months
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 29, 2024
- Primary completion
- Feb 8, 2026
- Completion
- Feb 8, 2026
- Last update posted
- Mar 10, 2026
2024 – 2026
United States locations
- U.S. sites
- 35
- U.S. states
- 11
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Emerson Clinical Research Institute | Washington D.C. | District of Columbia | 20009 | — |
| Bio-Medical Research LLC | Miami | Florida | 33144 | — |
| Tekton Research, LLC. | Chamblee | Georgia | 30341 | — |
| Javara - Privia Medical Group Georgia - Fayetteville | Fayetteville | Georgia | 30214 | — |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | — |
| The Iowa Clinic | Ankeny | Iowa | 50023 | — |
| Louisiana State University Health Sciences Shreveport - Fairfield avenue | Shreveport | Louisiana | 71101 | — |
| Louisiana State University Health Sciences Shreveport | Shreveport | Louisiana | 71103 | — |
| Ochsner/LSU Health Ambulatory Care Center | Shreveport | Louisiana | 71103 | — |
| University of Maryland, Baltimore - Institutional Review Board | Baltimore | Maryland | 21201 | — |
| University of Maryland, Baltimore, Center for Vaccine Development and Global Health | Baltimore | Maryland | 21201 | — |
| The Pediatric Center | Columbia | Maryland | 21045 | — |
| Atrium Health - Strive Vaccine Research Clinic | Charlotte | North Carolina | 28207 | — |
| Atrium Health-Myers Park | Charlotte | North Carolina | 28207 | — |
| Duke Vaccine and Trials Unit | Durham | North Carolina | 27703 | — |
| Durham Pediatrics at North Duke Street | Durham | North Carolina | 27704 | — |
| Duke University | Durham | North Carolina | 27705 | — |
| Atrium Health-Matthews | Matthews | North Carolina | 28105 | — |
| Senders Pediatrics | South Euclid | Ohio | 44121 | — |
| Carolina Family Care | Charleston | South Carolina | 29414 | — |
| MUSC Children's Health | Charleston | South Carolina | 29414 | — |
| Carolina Family Care | Summerville | South Carolina | 29486 | — |
| MUSC Children's Health | Summerville | South Carolina | 29486 | — |
| Holston Medical Group | Kingsport | Tennessee | 37660 | — |
| Pediatric Clinical Trials of Tennessee, LLC | Tullahoma | Tennessee | 37388 | — |
| Javara - Privia Medical Group North Texas - Dallas | Dallas | Texas | 75230 | — |
| Oak Cliff Research Company, LLC | Dallas | Texas | 75252 | — |
| Oak Cliff Research Company, LLC | Dallas | Texas | 75287 | — |
| Mercury Clinical Research - Houston | Houston | Texas | 77054 | — |
| DM Clinical Research - Kool Kids Pediatrics | Houston | Texas | 77065 | — |
| Kool Kids Pediatrics | Houston | Texas | 77065 | — |
| Mercury Clinical Research - Sunrise Pediatrics | Houston | Texas | 77077 | — |
| Mercury Clinical Research - Pediatric Associates | Houston | Texas | 77087 | — |
| University of Texas Medical Branch | League City | Texas | 77573 | — |
| Mercury Clinical Research - North Houston Internal Medicine & Pediatric Clinic | Tomball | Texas | 77375 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06531538, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 10, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06531538 live on ClinicalTrials.gov.