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
NCT ID: NCT03835975
Last Updated: 2021-02-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
875 participants
INTERVENTIONAL
2019-02-12
2020-02-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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13vPnC
Pneumococcal conjugate vaccine
13vPnC
Pneumococcal conjugate vaccine
PPSV23
Pneumococcal polysaccharide vaccine
PPSV23
Pneumococcal polysaccharide vaccine
20vPnC
Pneumococcal conjugate vaccine
20vPnC
Pneumococcal conjugate vaccine
Interventions
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13vPnC
Pneumococcal conjugate vaccine
PPSV23
Pneumococcal polysaccharide vaccine
20vPnC
Pneumococcal conjugate vaccine
Eligibility Criteria
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Inclusion Criteria
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
2. History of microbiologically proven invasive disease caused by S pneumoniae.
65 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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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
Kaiser Permanente Center For Health Research
Portland, Oregon, United States
Columbia Research Group, Inc.
Portland, Oregon, United States
Medical Research South, LLC
Goose Creek, South Carolina, United States
Ventavia Research Group
Keller, Texas, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, United States
J. Lewis Research, Inc. - Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Jordan River Family Medicine
South Jordan, Utah, United States
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
PharmaSite
Malmo, Skåne County, Sweden
Ladulaas Kliniska Studier
Borås, , Sweden
Infektionskliniken
Eskilstuna, , Sweden
CTC Gothia Forum
Gothenburg, , Sweden
ProbarE i Lund
Lund, , Sweden
Avdelningen for Kliniska Provningar
Örebro, , Sweden
Karolinska Trial Alliance, KTA Prim
Stockholm, , Sweden
Akardo Med Site
Stockholm, , Sweden
Countries
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References
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Cannon K, Elder C, Young M, Scott DA, Scully IL, Baugher G, Peng Y, Jansen KU, Gruber WC, Watson W. A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults >/=65 years of age with different prior pneumococcal vaccination. Vaccine. 2021 Dec 17;39(51):7494-7502. doi: 10.1016/j.vaccine.2021.10.032. Epub 2021 Nov 25.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2018-004278-91
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B7471006
Identifier Type: -
Identifier Source: org_study_id
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