A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants (NCT07573462)
A PHASE 3, RANDOMIZED, DOUBLE-BLINDED TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Starz Pediatrics — Estero, Florida
Age range: 42 Days to 98 Days
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (25 Sites)
- Starz Pediatrics — Estero, Florida
- Innovate Research Centers, LLC — Fort Lauderdale, Florida
- MacKoul Pediatrics Fort Myers — Fort Myers, Florida
- Rophe Adult and Pediatric Medicine/SKYCRNG — Union City, Georgia
- Rosemark Women Care Specialists — Idaho Falls, Idaho
- Eagle Clinical Research — Chicago, Illinois
- Kentucky Pediatric/ Adult Research — Bardstown, Kentucky
- LSU Health Shreveport Clinical Trials Office — Shreveport, Louisiana
- Ochsner/LSU Health Shreveport - Progressive Pediatrics — Shreveport, Louisiana
- Ochsner LSU Health Shreveport Ambulatory Care Center — Shreveport, Louisiana
- Ochsner/LSU Health Shreveport Academic Medical Center — Shreveport, Louisiana
- Pediatric Associates of Fall River — Fall River, Massachusetts
- Boston Children's Health Physicians — Hawthorne, New York
- Maria Fareri Children's Hospital — Valhalla, New York
- Senders Pediatrics — South Euclid, Ohio
- Legacy Clinical Trials — Oklahoma City, Oklahoma
- Cyn3rgy Research Corporation — Gresham, Oregon
- Donald Guthrie Foundation — Sayre, Pennsylvania
- Guthrie Medical Group — Sayre, Pennsylvania
- Tribe Clinical Research LLC. at Parkside Pediatrics Five Forks — Simpsonville, South Carolina
- Pediatric Research of Charlottesville, LLC. — Gordonsville, Virginia
- Perth Children's Hospital — Nedlands, Western Australia
- The Kids Research Institute Australia — Nedlands, Western Australia
- Milestone Research Inc. — London, Ontario
- Bluewater Clinical Research Group Inc. — Sarnia, Ontario
📞 Contact the Study Coordinator
Phone: (800) 718-1021
Email: ClinicalTrials.gov_Inquiries@pfizer.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Pneumococcal Disease
- A Study to Learn About How a New Pneumococcal Vaccine Works in Infants — Fayetteville, Arkansas
- Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents — Birmingham, Alabama
- A Study to Learn About How a New Pneumococcal Vaccine Works in Infants. — Birmingham, Alabama
Explore by condition: All Pneumococcal Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.