A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.

Recruiting now · Phase 3

Conditions studied: Pneumococcal Disease

In brief

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. It will also assess how the new vaccine works in comparison to the one that is currently in use when given with other childhood vaccines. To measure how the new pneumococcal vaccine compares to the current one, blood samples will be used to measure the body's ability to create proteins to fight those germs. 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 three groups in this study. All participants will be assigned to one of the three groups. This study is seeking participants who are: * infants who are 2 months of age in Group 1; * infants who are 2 to 6 months of age in Groups 2 and 3; and * said to be healthy by the study doctor About 3000 infants will be assigned to Group 1. The infants in this group will have a 1 in 2 chance (50%) of receiving 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. About 140 infants from outside the United States will be assigned to Group 2. The infants in this group will have a 1 in 2 chance (50%) of receiving either PG4 or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. About 90 infants from outside the United States will be assigned to Group 3. The infants in Group 3 will have a 1 in 3 chance (33%) of receiving either PG4 into the left thigh muscle, PG4 under the skin of the left thigh, or 20vPnC into the left thigh muscle at 2 to 6, 3 to 8, 4 to 10, and 12 to 15 months of age. Infants in Group 1 will take part in this study for about 16 to 19 months (about 1 and a half years). Infants in Groups 2 and 3 will take part in this study for 12 to 21 months (about 1 to 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. Infants will have 3 blood samples collected.

Key facts

Study ID

NCT07629440

Run by

Pfizer

People needed

3230

Starts

2026-05-29

Expected to finish

2029-06-05

Last updated by the study team

2026-07-09

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• infants who are 2 months of age in Group 1.
• infants who are 2 to 6 months of age in Groups 2 and 3.
• Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

You may not qualify if…

• 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, or planned receipt through study participation.

Where it is running

• MidValley Research, Inc — Moline, Illinois, United States (enrolling)
• ACC Pediatric Research — Haughton, Louisiana, United States (enrolling)
• Bingham Memorial Hospital — Blackfoot, Idaho, United States (enrolling)
• ASR, LLC — Boise, Idaho, United States (enrolling)
• Integrity Clinical Network, LLC — Derby, Kansas, United States (enrolling)
• San Gabriel Woman's Health — Arcadia, California, United States (enrolling)
• Family Medical Clinic — El Monte, California, United States (enrolling)
• Northwest Arkansas Pediatric Clinic — Fayetteville, Arkansas, United States (enrolling)
• Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates — Birmingham, Alabama, United States (enrolling)
• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States (enrolling)
• Eximia Research - IA, LLC (dba Integrated Clinical Trial Services, LLC) — West Des Moines, Iowa, United States (enrolling)
• Childrens Hospital of Colorado — Aurora, Colorado, United States (enrolling)
• Direct Helpers Research Center — Hialeah, Florida, United States (enrolling)
• C & R Research Services USA — Homestead, Florida, United States (enrolling)
• Florida Pharmaceutical Research and Associates, Inc. — Miami, Florida, United States (enrolling)
• Bioresearch Partner — Miami, Florida, United States (enrolling)
• Gold Coast Health Research Center, LLC — Miami, Florida, United States (enrolling)
• Clinical Research of Central California — Fresno, California, United States (enrolling)
• SeraCollection Research Services, LLC — Montebello, California, United States (enrolling)
• Riveldi and Associates — Miami Lakes, Florida, United States (enrolling)
• Eminent Clinical Research and Associates — North Lauderdale, Florida, United States (enrolling)
• Cordova Research Institute LLC — Sweetwater, Florida, United States (enrolling)
• Altruistic Clinical Research Global — Norcross, Georgia, United States (enrolling)
• Medical Research Partners — Ammon, Idaho, United States (enrolling)
• Kur Research, LLC — Columbia, Maryland, United States (enrolling)

Full record on ClinicalTrials.gov

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