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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
225
Multivalent pneumococcal conjugate vaccine.
20-valent pneumococcal conjugate vaccine (20vPnC)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From signing of ICD to 6 months after last assigned vaccination
Pneumococcal serotype specific IgG concentrations
Pneumococcal IgG GMCs 1 month after the last assigned vaccination
Time frame: 1 month after last assigned vaccination
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Emerson Clinical Research Institute
Washington D.C., District of Columbia, United States
Bio-Medical Research LLC
Miami, Florida, United States
Riveldi Biomedical Research and Associates - Miami Lakes
Miami Lakes, Florida, United States
Tekton Research, LLC.
Chamblee, Georgia, 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
...and 37 more locations