20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study in Pneumococcal Vaccine-Naïve Adults 60 Years of Age and Older in Japan, Korea, and Taiwan

  • STATUS
    Recruiting
  • days left to enroll
    58
  • participants needed
    1400
  • sponsor
    Pfizer
Updated on 19 January 2022
pneumococcal conjugate
polysaccharide
conjugate vaccine
pneumococcal vaccine
Accepts healthy volunteers

Summary

A phase 3, randomized, double-blind trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in pneumococcal vaccine-naïve adults 60 years of age and older in Japan, Korea, and Taiwan

Details
Condition Pneumococcal Disease
Treatment Saline, PPSV23, 13vPnC, 20vPnC
Clinical Study IdentifierNCT04875533
SponsorPfizer
Last Modified on19 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female participants 60 years of age and older at the time of consent
Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of study intervention. (For adults 60 through 64 years of age to be enrolled at Japan sites: Participants must have a preexisting chronic stable disease with an elevated risk for pneumococcal disease.)

Exclusion Criteria

History of microbiologically proven invasive disease caused by S pneumoniae
Serious chronic disorder, including metastatic malignancy, severe COPD requiring supplemental oxygen, end-stage renal disease with or without dialysis, cirrhosis of the liver, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the participant from participating in the study
Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation
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Step 1 Connect with a study center
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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