A Study to Learn About How a New Pneumococcal Vaccine Works in Infants
NCT Number: NCT06524414
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Pneumococcal Disease
Interventions: BIOLOGICAL: PG4|BIOLOGICAL: 20-valent pneumococcal conjugate vaccine (20vPnC)
Sponsor: Pfizer
Sex: ALL
Age: CHILD
Enrollment: 400
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-25
Completion Date: 2026-07-14
Locations: Northwest Arkansas Pediatric Clinic, Fayetteville, Arkansas, 72703, United States|The Children's Clinic, Jonesboro, Arkansas, 72401, United States|Los Ninos Children's Medical Clinic, La Puente, California, 91744, United States|Private Practice - Dr. Carey Chronis, Ventura, California, 93003, United States|Center for Clinical Trials of San Gabriel, West Covina, California, 91790, United States|Riveldi Biomedical Research and Associates - Miami, Miami Lakes, Florida, 33014, United States|Clinical Research Prime, Idaho Falls, Idaho, 83404, United States|Clinical Research Prime Rexburg, Rexburg, Idaho, 83440, United States|The Iowa Clinic, Ankeny, Iowa, 50023, United States|Cotton O'Neil Pediatrics, Topeka, Kansas, 66604, United States|Kentucky Pediatric/ Adult Research, Bardstown, Kentucky, 40004, United States|All Children Pediatrics, Louisville, Kentucky, 40243, United States|Bluegrass Clinical Research, Inc., Louisville, Kentucky, 40291, United States|LSUHSC Clinical Trials Office, Shreveport, Louisiana, 71101, United States|Louisiana State University Health Sciences Shreveport, Shreveport, Louisiana, 71103, United States|Ochsner/LSU Health Ambulatory Care Center, Shreveport, Louisiana, 71103, United States|University of Maryland, Baltimore, Maryland, 21201, United States|UMB/CVD, Frederick, Maryland, 21702, United States|Pediatric Associates of Fall River, Fall River, Massachusetts, 02721, United States|Midwest Children's Health Research Institute, Lincoln, Nebraska, 68522, United States|Duke Vaccine and Trials Unit, Durham, North Carolina, 27703, United States|Durham Pediatrics at North Duke Street, Durham, North Carolina, 27704, United States|Dayton Clinical Research, Dayton, Ohio, 45409, United States|Ohio Pediatric Research Assn., Dayton, Ohio, 45414, United States|Senders Pediatrics, South Euclid, Ohio, 44121, United States|Cyn3rgy Research, Gresham, Oregon, 97030, United States|Coastal Pediatric Research, Summerville, South Carolina, 29486, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Javara - Privia Medical Group North Texas - Dallas, Dallas, Texas, 75230, United States|Oak Cliff Research Company, LLC, Dallas, Texas, 75252, United States|Oak Cliff Research Company, LLC, Dallas, Texas, 75287, United States|PAS Research - McAllen, Edinburg, Texas, 78539, United States|Pediatric Associates, Houston, Texas, 77087, United States|University of Texas Medical Branch, League City, Texas, 77573, United States|DCOL Center for Clinical Research, Longview, Texas, 75605, United States|Alliance for Multispecialty Research, LLC, Kaysville, Utah, 84037, United States|Alliance for Multispecialty Research, LLC, Layton, Utah, 84041, United States|Alliance for Multispecialty Research, LLC, Murray, Utah, 84107, United States|Alliance for Multispecialty Research, LLC, Provo, Utah, 84604, United States|Alliance for Multispecialty Research, LLC, Roy, Utah, 84067, United States|Alliance for Multispecialty Research, LLC, South Jordan, Utah, 84095, United States|Alliance for Multispecialty Research, LLC, Syracuse, Utah, 84075, United States|Pediatric Research of Charlottesville, LLC, Charlottesville, Virginia, 22902, United States|Clinical Research Puerto Rico, Guayama, 00784, Puerto Rico|Ponce Medical School Foundation Inc., Ponce, 00716, Puerto Rico|BRCR Global Puerto Rico, San Juan, 00907-1509, Puerto Rico|Caribbean Medical Research Center, San Juan, 00918, Puerto Rico|San Miguel Medical, Trujillo Alto, 00976, Puerto Rico

Summary:
The purpose of this study is to learn about the safety and immune effects of a new pneumococcal vaccine in infants. 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 us understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease, which include 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

The participants will be assigned to one of two groups to receive 4 doses of either PG4 (the new vaccine being studied) or 20vPnC (Prevnar 20) at 2, 4, 6, and 12 to 15 months of age. The vaccines will be given as a single shot into the left thigh muscle. Participants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, participants will have 6 study clinic visits and 1 to 2 phone calls. At these study clinic visits, parent(s) or legal guardian(s) will be asked if the participant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. Participants in both groups will have 3 blood draws.

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Primary Outcome Measures: Percentage of participants reporting local reactions within 7 days after each dose, Prompted local reactions after each dose, Day 7|Percentage of participants reporting systemic events within 7 days after each dose, Prompted systemic reactions after each dose, Day 7|Percentage of participants reporting adverse events (AEs), AEs occurring from Dose 1 to 1 month after Dose 2, Dose 1 to 1 month after Dose 3|Percentage of participants reporting AEs, AEs occurring from Dose 4 to 1 month after Dose 4, Dose 4 to 1 month after Dose 4
Secondary Outcome Measures: Pneumococcal immunoglobulin G (IgG) geometric mean concentrations (GMCs), Pneumococcal IgG GMCs 1 month after Dose 4, 1 month after Dose 4