A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Public ClinicalTrials.gov record NCT07573462. 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 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 that can cause pneumonia (lung infections), meningitis (brain infections), and otitis media (ear infections) in infants when compared to the pneumococcal vaccine that is currently in use, 20vPnC (Prevnar 20®). This study will test if the new pneumococcal vaccine is as safe as the one that is currently in use. This new vaccine can possibly provide additional protection against germs that cause pneumococcal disease that are not included in the vaccines that are currently given to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. There are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are: \- infants who are about 2 months of age About 2400 infants will be assigned by chance to one of the two groups to receive either PG4 (new vaccine) or 20vPnC (currently in use) into the left thigh muscle at 2, 4, 6, and 12 to 15 months of age. Infants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, infants will have 6 study clinic visits and 1 phone call. At these study clinic visits, parent(s)/legal guardian(s) will be asked if the infant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine.
Study identification
- NCT ID
- NCT07573462
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,400 participants
Conditions and interventions
Conditions
Interventions
- PG4 Biological
- 20-valent pneumococcal conjugate vaccine (20vPnC) Biological
Biological
Eligibility (public fields only)
- Age range
- 42 Days to 98 Days
- 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
- May 3, 2026
- Primary completion
- Dec 29, 2028
- Completion
- Dec 29, 2028
- Last update posted
- Aug 9, 2026
2026 – 2028
United States locations
- U.S. sites
- 21
- U.S. states
- 14
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Starz Pediatrics | Estero | Florida | 33928 | Recruiting |
| Innovate Research Centers, LLC | Fort Lauderdale | Florida | 33304 | Recruiting |
| MacKoul Pediatrics Fort Myers | Fort Myers | Florida | 33908 | Recruiting |
| Rophe Adult and Pediatric Medicine/SKYCRNG | Union City | Georgia | 30291 | Recruiting |
| Rosemark Women Care Specialists | Idaho Falls | Idaho | 83404 | Recruiting |
| Eagle Clinical Research | Chicago | Illinois | 60621 | Recruiting |
| Kentucky Pediatric/ Adult Research | Bardstown | Kentucky | 40004 | Recruiting |
| LSU Health Shreveport Clinical Trials Office | Shreveport | Louisiana | 71101 | Recruiting |
| Ochsner/LSU Health Shreveport - Progressive Pediatrics | Shreveport | Louisiana | 71101 | Recruiting |
| Ochsner LSU Health Shreveport Ambulatory Care Center | Shreveport | Louisiana | 71103 | Recruiting |
| Ochsner/LSU Health Shreveport Academic Medical Center | Shreveport | Louisiana | 71103 | Recruiting |
| Pediatric Associates of Fall River | Fall River | Massachusetts | 02721 | Not yet recruiting |
| Boston Children's Health Physicians | Hawthorne | New York | 10532 | Recruiting |
| Maria Fareri Children's Hospital | Valhalla | New York | 10595 | Recruiting |
| Senders Pediatrics | South Euclid | Ohio | 44121 | Recruiting |
| Legacy Clinical Trials | Oklahoma City | Oklahoma | 73103 | Recruiting |
| Cyn3rgy Research Corporation | Gresham | Oregon | 97030 | Recruiting |
| Donald Guthrie Foundation | Sayre | Pennsylvania | 18840 | Not yet recruiting |
| Guthrie Medical Group | Sayre | Pennsylvania | 18840 | Not yet recruiting |
| Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks | Simpsonville | South Carolina | 29680 | Recruiting |
| Pediatric Research of Charlottesville, LLC. | Gordonsville | Virginia | 22942 | Recruiting |
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 NCT07573462, 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 Aug 9, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07573462 live on ClinicalTrials.gov.