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A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
NCT06524414 · View on ClinicalTrials.gov ↗
Study Summary
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 in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine. To ensure that the new vaccine (PG4) stays stable, it is placed in a liquid mixture of sterile water and other substances (a solution). This study will also test if there is a difference in the safety and immune effects of the new pneumococcal vaccine when it is one type of solution compared to when it is in a different type of solution. The immune response is how the body's cells; tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. This study is seeking participants who are: * male or female infants who are 2 months of age, * infants born at 36 weeks (about 8 and a half months) of pregnancy or later; and, * said to be healthy by the study doctor There are four groups in this study. All participants will be assigned to one of the four groups. All study vaccines will be given as a single shot into the left thigh muscle. Participants in the three groups will have 3 blood samples collected during the 1 and a half years they are in the study. The first 400 participants who enter the study will be assigned to either Group 1 or Group 2. Half the participants in Group 1 and half the participants in Group 2 will receive 4 doses at 2, 4, 6, and 12 to 15 months of age of PG4 mixed in the first solution. The other half of the participants in Gro
Conditions Studied
Interventions
- BIOLOGICAL PG4
- BIOLOGICAL 20-valent pneumococcal conjugate vaccine (20vPnC)
- BIOLOGICAL 15-valent pneumococcal conjugate vaccine (PCV15)
Study Locations (20)
California
- Los Ninos Children's Medical Clinic — La Puente
- Stanford University Medical Center — Palo Alto
- Los Ninos Children's Medical Clinic — West Covina
Kentucky
- Kentucky Pediatric/ Adult Research — Bardstown
- All Children Pediatrics — Louisville
- Bluegrass Clinical Research, Inc. — Louisville
Louisiana
- LSUHSC Clinical Trials Office — Shreveport
- Louisiana State University Health Sciences Shreveport — Shreveport
- Ochsner/LSU Health Ambulatory Care Center — Shreveport
Arkansas
- Northwest Arkansas Pediatric Clinic — Fayetteville
- The Children's Clinic — Jonesboro
Maryland
- University of Maryland — Baltimore
- UMB/CVD — Frederick
District of Columbia
- Velocity Clinical Research, Washington DC — Washington D.C.
Florida
- Riveldi Biomedical Research and Associates - Miami — Miami Lakes
Idaho
- Clinical Research Prime — Idaho Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 605 participants |
| Start Date | 2024-07-25 |
| Est. Completion | 2027-05-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06524414
The ClinicalTrials.gov registry entry for NCT06524414 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 605 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer, which has 769 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pneumococcal Disease appearing as the primary indexed condition, and to 3 interventions — of which PG4 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06524414 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Kentucky, Louisiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06524414 about?
NCT06524414 is a clinical study titled "A Study to Learn About How a New Pneumococcal Vaccine Works in Infants". 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 in infants when compared to the pneumococcal vaccines that are currently in use, 20vPnC (Prevnar 20®) or another licensed pneumococcal vaccine. To e...
What is the current status of trial NCT06524414?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 605 participants. The study started on 2024-07-25. Estimated completion is 2027-05-01.
What conditions does trial NCT06524414 study?
This clinical trial studies the following conditions: Pneumococcal Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06524414?
The interventions under investigation include: PG4 (BIOLOGICAL), 20-valent pneumococcal conjugate vaccine (20vPnC) (BIOLOGICAL), 15-valent pneumococcal conjugate vaccine (PCV15) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06524414?
This trial is sponsored by Pfizer, which has 769 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06524414 being conducted?
This trial has 20 study locations across Arkansas, California, District of Columbia, Florida, Idaho. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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