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A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults

RecruitingPhase 3Ages 18 Years - 49 YearsAllPfizer
NCT07794748 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 provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine. This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines. The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC. Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 par

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📋 Eligibility rules (as published)
Inclusion Criteria: Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age. Exclusion Criteria: Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.
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What it tests

  • PG4 Multivalent Vaccine
  • PG4 Multivalent Vaccine
  • PG4 Multivalent Vaccine
  • 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
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Where

37 sites
Achieve Clinical Research, LLC d/b/a Accel Research Sites - Birmingham Clinical Research Unit
Birmingham, United States
Orange County Research Center
Lake Forest, United States
Diablo Clinical Research, LLC dba Flourish Research
Walnut Creek, United States
Clinical Research Consulting
Milford, United States
Suncoast Research Associates
Doral, United States
Research Centers of America
Hollywood, United States
East Coast Institute for Research, LLC
Jacksonville, United States
Entrust Clinical Research
Miami, United States

…and 29 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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