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A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants

RecruitingPhase 3Ages 42 Days - 98 DaysAllPfizer
NCT07573462 on ClinicalTrials.gov ↗
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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 infants 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. 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 to infants. Pneumococcal disease includes a variety of infections caused by a specific germ, Streptococcus pneumoniae. There are two groups in this study. All participants will be assigned to one of the two groups. This study is seeking participants who are: \- infa

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📋 Eligibility rules (as published)
Inclusion Criteria: * Infants who are about 2 months of age * Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study. Exclusion Criteria: * 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, or planned receipt through study participation.
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What it tests

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

78 sites
Starz Pediatrics
Estero, United States
Innovate Research Centers, LLC
Fort Lauderdale, United States
MacKoul Pediatrics Fort Myers
Fort Myers, United States
Speranza Research Center
Hialeah, United States
Dr. Gala, LLC
Miami, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
Union City, United States
Rosemark Women Care Specialists
Idaho Falls, United States
Eagle Clinical Research
Chicago, United States

…and 70 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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