A Study to Learn About How a New Pneumococcal Vaccine Works in Children
- Conditions
- Pneumococcal Disease
- Interventions
- Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)
- Registration Number
- NCT06531538
- Lead Sponsor
- Pfizer
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- Male or female toddlers ≥12 to ≤15 months of age at the time of consent.
- Healthy toddlers determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.
- Have received 3 infant doses of 20vPnC at 2, 4, and 6 months of age, with the last dose administered >56 days before enrollment into the study. Documented confirmation of receipt will be collected prior to randomization.
- 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 (other than 20vPnC) or planned receipt during study participation.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PG4 2-Dose Group PG4 Participants to receive two injections of Multivalent Pneumococcal Vaccine 20-valent pneumococcal conjugate vaccine (20vPnC) 20-valent pneumococcal conjugate vaccine (20vPnC) Participants to receive a single injection of 20-valent pneumococcal conjugate vaccine (20vPnC). PG4 1-Dose Group PG4 Participants to receive a single injection of Multivalent Pneumococcal Vaccine
- Primary Outcome Measures
Name Time Method Percentage of participants reporting prespecified local reactions within 7 days after each dose 7 days after each dose Prespecified local reactions (redness, swelling, and pain at the injection site) after each dose
Percentage of participants reporting Adverse Events (AEs) within 1 month after the last assigned vaccination From signing of ICD to 1 month after last assigned vaccination Adverse events occurring within 1 month after the last assigned vaccination
Percentage of participants reporting prespecified systemic events within 7 days after each dose 7 days after each dose Prespecified systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability) after each dose
Percentage of participants reporting Serious Adverse Events (SAEs) within 6 months after vaccination From signing of ICD to 6 months after last assigned vaccination SAEs occurring from Dose 1 through 6 months after the last assigned vaccination
- Secondary Outcome Measures
Name Time Method Pneumococcal serotype specific IgG concentrations 1 month after last assigned vaccination Pneumococcal IgG GMCs 1 month after the last assigned vaccination
Trial Locations
- Locations (44)
Bluegrass Clinical Research, Inc.
🇺🇸Louisville, Kentucky, United States
Bio-Medical Research LLC
🇺🇸Miami, Florida, United States
Tekton Research, LLC.
🇺🇸Beaumont, Texas, United States
Javara - Privia Medical Group Georgia - Fayetteville
🇺🇸Fayetteville, Georgia, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Clinical Research Prime
🇺🇸Idaho Falls, Idaho, United States
Clinical Research Prime Rexburg
🇺🇸Rexburg, Idaho, United States
The Iowa Clinic
🇺🇸Ankeny, Iowa, United States
All Children Pediatrics
🇺🇸Louisville, Kentucky, United States
Louisiana State University Health Sciences Shreveport - Fairfield avenue
🇺🇸Shreveport, Louisiana, United States
Louisiana State University Health Sciences Shreveport
🇺🇸Shreveport, Louisiana, United States
University of Maryland, Baltimore
🇺🇸Baltimore, Maryland, United States
Ochsner/LSU Health Ambulatory Care Center
🇺🇸Shreveport, Louisiana, United States
University of Maryland, Baltimore, Center for Vaccine Development and Global Health
🇺🇸Baltimore, Maryland, United States
The Pediatric Center
🇺🇸Columbia, Maryland, United States
Child Health Care Associates
🇺🇸East Syracuse, New York, United States
The Pediatric Center of Frederick
🇺🇸Frederick, Maryland, United States
Atrium Health - Strive Vaccine Research Clinic
🇺🇸Charlotte, North Carolina, United States
Rochester Clinical Research, LLC
🇺🇸Rochester, New York, United States
Cyn3rgy Research
🇺🇸Gresham, Oregon, United States
Atrium Health-Myers Park
🇺🇸Charlotte, North Carolina, United States
Duke Vaccine and Trials Unit
🇺🇸Durham, North Carolina, United States
Durham Pediatrics at North Duke Street
🇺🇸Durham, North Carolina, United States
Atrium Health-Matthews
🇺🇸Matthews, North Carolina, United States
Javara - Wake Forest Health Network - Ford, Simpson, Lively & Rice Pediatrics
🇺🇸Winston-Salem, North Carolina, United States
Senders Pediatrics
🇺🇸South Euclid, Ohio, United States
Allegheny Health and Wellness Pavilion
🇺🇸Erie, Pennsylvania, United States
Coastal Pediatric Research
🇺🇸Summerville, South Carolina, United States
Javara - Privia Medical Group North Texas - Dallas
🇺🇸Dallas, Texas, United States
Oak Cliff Research Company, LLC
🇺🇸Dallas, Texas, United States
Holston Medical Group
🇺🇸Kingsport, Tennessee, United States
PAS Research - McAllen
🇺🇸Edinburg, Texas, United States
Mercury Clinical Research - Houston
🇺🇸Houston, Texas, United States
DM Clinical Research
🇺🇸Houston, Texas, United States
Pediatric Associates
🇺🇸Houston, Texas, United States
University of Texas Medical Branch
🇺🇸League City, Texas, United States
Kool Kids Pediatrics
🇺🇸Houston, Texas, United States
Sunrise Pediatrics
🇺🇸Houston, Texas, United States
North Houston Internal Medicine & Pediatric Clinic
🇺🇸Tomball, Texas, United States
Ponce Medical School Foundation Inc.
🇵🇷Ponce, Puerto Rico
BRCR Medical Center - Ponce
🇵🇷Ponce, Puerto Rico
BRCR Global Puerto Rico
🇵🇷San Juan, Puerto Rico
Caribbean Medical Research Center
🇵🇷San Juan, Puerto Rico
Riveldi Biomedical Research and Associates - Miami Lakes
🇺🇸Miami Lakes, Florida, United States