Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination



Status:Recruiting
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:65 - Any
Updated:2/28/2019
Start Date:February 12, 2019
End Date:December 30, 2019
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS ≥65 YEARS OF AGE WITH PRIOR PNEUMOCOCCAL VACCINATION

This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal
conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal
vaccination


Inclusion Criteria

1. Male or female adults 65 years of age or greater.

2. 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 investigational product.

3. Female subject of nonchildbearing potential; male subject not able to father children
or who is able to father children and willing to use a highly effective method of
contraception.

4. Male or female adults who meet 1 of the following:

1. Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to
5 years prior to vaccination in the study, and no prior 13vPnC vaccination
(Cohort A).

2. Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in
the study, and no prior PPSV23 vaccination (Cohort B).

3. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or
equal to 1 year prior to vaccination in the study) (Cohort C).

Exclusion Criteria

1. Serious chronic disorder including metastatic malignancy, severe chronic obstructive
pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with
or without dialysis, clinically unstable cardiac disease, or any other disorder that,
in the investigator's opinion, excludes the subject from participating in the study.

2. History of microbiologically proven invasive disease caused by S pneumoniae.
We found this trial at
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Phoenix, Arizona 85027
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2080 Bridgeport Avenue
Milford, Connecticut 06460
203-386-3115
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1709 S Rock Rd
Wichita, Kansas 67207
316-689-6629
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1085 N Harbor Blvd
Anaheim, California 92801
(714) 774-7777
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Cincinnati, Ohio 45219
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Franklin, Ohio 45005
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Goose Creek, South Carolina 29445
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Honolulu, Hawaii 96814
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Mobile, Alabama 36608
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Norfolk, Nebraska 68701
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9401 West Thunderbird Road
Peoria, Arizona 85381
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Stockbridge, Georgia 30281
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Walnut creek, California 94598
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