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Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents

RecruitingPhase 3Ages 15 Months - 17 YearsAllPfizer
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In plain words

What the trial is, and whether it could suit you

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 children 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. 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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: Cohort 1 (Participants ≥15 Months to \<2 Years of Age) Healthy toddlers and children ≥15 months to \<2 years of age with documentation of prior receipt of PCV. Cohort 2 (Participants ≥2 Years to \<5 Years of Age) Healthy toddlers and children ≥2 years to \<5 years of age with documentation of prior receipt of PCV if applicable. Cohort 3 (Participants ≥5 Years to \<18 Years of Age) Healthy children ≥5 years to \<18 years of age with documentation of prior receipt of PCV (if applicable). A negative urine pregnancy test is required for individuals of childbearing potential (IOCBP). IOCBP or participants able to father must also agree to use a highly effective method of birth control. Exclusion Criteria: All Cohorts (Participants ≥15 Months to \<18 Years of Age) Children with significant medical, psychiatric, or neurological conditions (eg, immunodeficiency or history of seizure); or a history of confirmed invasive pneumococcal infection in the past will be excluded from enrolment in the trial
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What it tests

  • PG4
  • 20-valent pneumococcal conjugate vaccine (20vPnC)
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Where

77 sites
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
Birmingham, United States
UAB Child Health Research Unit (CHRU)
Birmingham, United States
Lakeview Clinical Research, LLC
Guntersville, United States
Apex Research Group
Fair Oaks, United States
Orange County Research Institute
Ontario, United States
Children's Hospital Colorado
Aurora, United States
Riveldi and Associates
Miami Lakes, United States
Indago Research & Health Center, Inc
Miami Lakes, United States

…and 69 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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