Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
NCT ID: NCT03313037
Last Updated: 2019-12-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
444 participants
INTERVENTIONAL
2017-10-10
2018-12-10
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
TRIPLE
Study Groups
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Multivalent
Pneumococcal conjugate vaccine
Saline
Placebo
Multivalent
Pneumococcal conjugate vaccine
Control
Prevnar 13 and PPSV23
Prevnar 13
Pneumococcal conjugate vaccine
PPSV23
Pneumococcal polysaccharide vaccine
Interventions
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Prevnar 13
Pneumococcal conjugate vaccine
PPSV23
Pneumococcal polysaccharide vaccine
Saline
Placebo
Multivalent
Pneumococcal conjugate vaccine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Healthy adults, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy or requiring hospitalization within 3 months before receipt of investigational product, as determined by medical history, physical examination, laboratory screening, and clinical judgment of the investigator.
3. Female subjects who are not of childbearing potential.
Exclusion Criteria
2. History of microbiologically proven invasive disease caused by S pneumoniae.
3. 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.
60 Years
64 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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Anaheim Clinical Trials, LLC
Anaheim, California, United States
Clinical Research of South Florida
Coral Gables, Florida, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
Qps-Mra, Llc
South Miami, Florida, 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
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Medical Research South, LLC
Charleston, South Carolina, United States
Benchmark Research
Austin, Texas, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Martin Diagnostic Clinic
Tomball, Texas, United States
J. Lewis Research Inc. / Foothill Family Clinic Draper
Draper, Utah, United States
J. Lewis Research, Inc. - Jordan River Family Medicine
South Jordan, Utah, United States
Countries
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References
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Hurley D, Griffin C, Young M, Scott DA, Pride MW, Scully IL, Ginis J, Severs J, Jansen KU, Gruber WC, Watson W. Safety, Tolerability, and Immunogenicity of a 20-Valent Pneumococcal Conjugate Vaccine (PCV20) in Adults 60 to 64 Years of Age. Clin Infect Dis. 2021 Oct 5;73(7):e1489-e1497. doi: 10.1093/cid/ciaa1045.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B7471002
Identifier Type: -
Identifier Source: org_study_id