Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
17 participants
INTERVENTIONAL
2017-10-01
2020-12-25
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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PCV13 and PPSV23
Participants randomized to receive PPSV23 primed with PCV13. Participants will receive PCV13 8 weeks prior to receiving PPSV23
PCV13
Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
PPSV23
Participants randomized to receive PPSV23 alone
PPSV23
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Interventions
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PCV13
Single 0.5 ml dose of PCV13 administered via intramuscular injection
PPSV23
Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of PCV-13 vaccination
* History of cochlear implant
* Cerebrospinal Fluid (CSF) leak
* Congestive Heart Failure (CHF)
* Diabetes Mellitus (DM)
* Chronic Kidney Disease (CKD)
* Human Immunodeficiency Virus (HIV)
* Common Variable Immune Deficiency (CVID)
* Patients who have received the PPSV23 vaccine in the last 5 years
* Women who are pregnant will also be excluded from the study by performing 2 point of care urine pregnancy tests ( prior to vaccinations)
19 Years
64 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Avni Joshi
Principal Investigator
Principal Investigators
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Avni Y Joshi
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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16-007731
Identifier Type: -
Identifier Source: org_study_id