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

Completed · Phase 3

Conditions studied: Pneumococcal Disease

In brief

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

Key facts

Study ID

NCT03835975

Run by

Pfizer

People needed

875

Starts

2019-02-12

Expected to finish

2020-02-12

Last updated by the study team

2021-02-21

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female adults 65 years of age or greater.
• 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.
• 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.
• Male or female adults who meet 1 of the following:
• 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).
• Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B).
• Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or equal to 1 year prior to vaccination in the study) (Cohort C).

You may not qualify if…

• 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.
• History of microbiologically proven invasive disease caused by S pneumoniae.

Where it is running

• Coastal Clinical Research, Inc. — Mobile, Alabama, United States
• East Valley Gastroenterology and Hepatology Associates — Chandler, Arizona, United States
• The Pain Center of Arizona — Peoria, Arizona, United States
• HOPE Research Institute — Phoenix, Arizona, United States
• The Pain Center of Arizona — Phoenix, Arizona, United States
• Anaheim Clinical Trials, LLC — Anaheim, California, United States
• Diablo Clinical Research, Inc. — Walnut Creek, California, United States
• Clinical Research Consulting, LLC — Milford, Connecticut, United States
• Optimal Research, LLC — Melbourne, Florida, United States
• Synexus Clinical Research US, Inc — The Villages, Florida, United States
• Meridian Clinical Research, LLC — Savannah, Georgia, United States
• Clinical Research Atlanta — Stockbridge, Georgia, United States
• East-West Medical Research Institute — Honolulu, Hawaii, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• Heartland Research Associates, LLC — Wichita, Kansas, United States
• MedPharmics, LLC — Metairie, Louisiana, United States
• Meridian Clinical Research, LLC — Rockville, Maryland, United States
• Meridian Clinical Research, LLC — Norfolk, Nebraska, United States
• MedPharmics, LLC — Albuquerque, New Mexico, United States
• Carolina Institute for Clinical Research — Fayetteville, North Carolina, United States
• PMG Research of Wilmington, LLC — Wilmington, North Carolina, United States
• CTI Clinical Research Center — Cincinnati, Ohio, United States
• Sterling Research Group, Ltd. — Cincinnati, Ohio, United States
• Prestige Clinical Research — Franklin, Ohio, United States
• Lynn Health Science Institute — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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