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A Study to Learn About How a New Pneumococcal Vaccine Works in Infants.

RecruitingPhase 3Ages 42 Days - 211 DaysAllPfizer
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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 20ยฎ). 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 when given with other childhood vaccines. 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

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

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * infants who are 2 months of age in Group 1. * infants who are 2 to 6 months of age in Groups 2 and 3. * 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

130 sites
KUR Research, LLC
Bessemer, United States
Alabama Clinical Therapeutics, LLC Birmingham Pediatric Associates
Birmingham, United States
University of Alabama at Birmingham - School of Medicine
Birmingham, United States
Northwest Arkansas Pediatric Clinic
Fayetteville, United States
The Children's Clinic of Jonesboro, P.A.
Jonesboro, United States
Helios Clinical Research
Sherwood, United States
Advanced Research Center, Inc.
Anaheim, United States
San Gabriel Woman's Health
Arcadia, United States

โ€ฆand 122 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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