A Study to Learn About How a New Pneumococcal Vaccine Works in Children
NCT Number: NCT06531538
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: 300
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-07-30
Completion Date: 2025-09-19
Locations: Riveldi Biomedical Research and Associates - Miami Lakes, Miami Lakes, Florida, 33014, United States|Bio-Medical Research LLC, Miami, Florida, 33144, United States|Tekton Research, LLC., Chamblee, Georgia, 30341, United States|Javara - Privia Medical Group Georgia - Fayetteville, Fayetteville, Georgia, 30214, United States|Rophe Adult and Pediatric Medicine/SKYCRNG, Union City, Georgia, 30291, 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|All Children Pediatrics, Louisville, Kentucky, 40243, United States|Bluegrass Clinical Research, Inc., Louisville, Kentucky, 40291, United States|Louisiana State University Health Sciences Shreveport - Fairfield avenue, 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|Child Health Care Associates, East Syracuse, New York, 13057, United States|Rochester Clinical Research, LLC, Rochester, New York, 14609, 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|Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics, Winston-Salem, North Carolina, 27103, United States|Senders Pediatrics, South Euclid, Ohio, 44121, United States|Cyn3rgy Research, Gresham, Oregon, 97030, United States|Allegheny Health and Wellness Pavilion, Erie, Pennsylvania, 16506, United States|Coastal Pediatric Research, Summerville, South Carolina, 29486, United States|Holston Medical Group, Kingsport, Tennessee, 37660, United States|Tekton Research, LLC., Beaumont, Texas, 77706, 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|Mercury Clinical Research - Houston, Houston, Texas, 77054, United States|DM Clinical Research, Houston, Texas, 77065, United States|Kool Kids Pediatrics, Houston, Texas, 77065, United States|Sunrise Pediatrics, Houston, Texas, 77077, United States|Pediatric Associates, Houston, Texas, 77087, United States|University of Texas Medical Branch, League City, Texas, 77573, United States|North Houston Internal Medicine & Pediatric Clinic, Tomball, Texas, 77375, United States|Ponce Medical School Foundation Inc., Ponce, 00716, Puerto Rico|BRCR Medical Center - Ponce, Ponce, 00717, Puerto Rico|BRCR Global Puerto Rico, San Juan, 00907-1509, Puerto Rico|BRCR Global Puerto Rico, San Juan, 00907, Puerto Rico|Caribbean Medical Research Center, San Juan, 00918, Puerto Rico

Summary:
The purpose of this study is to learn about the safety, tolerability and immune effects of a pneumococcal vaccine in toddlers.

Participants will take part in this study for approximately 6 or 8 months depending on which group they are assigned to. During this time participants will have 2 clinic visits and 1 phone visit for the 1-Dose group, or 3 clinic visits and 1 phone visit for the 2-Dose group.

At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during some clinic visits.

Primary Outcome Measures: Percentage of participants reporting prespecified local reactions within 7 days after each dose, Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose, 7 days after each dose|Percentage of participants reporting prespecified systemic events within 7 days after each dose, Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose, 7 days after each dose|Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination, Adverse events occurring within 1 month after the last assigned vaccination, From signing of ICD to 1 month after last assigned vaccination|Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination, SAEs occurring from Dose 1 through 6 months after the last assigned vaccination, From signing of ICD to 6 months after last assigned vaccination
Secondary Outcome Measures: Pneumococcal serotype specific IgG concentrations, Pneumococcal IgG GMCs 1 month after the last assigned vaccination, 1 month after last assigned vaccination