Status:
COMPLETED
Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infection
Eligibility:
All Genders
70-89 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine if revaccination with pneumococcal vaccine (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese adults. The primary hypot...
Eligibility Criteria
Inclusion
- Japanese participant
- Good health or any underlying chronic illness is documented to be in stable condition
- Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5 years before enrollment in the study
- Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination
Exclusion
- Known allergy or sensitivity to any of the components of the study vaccine
- History of pneumococcal conjugate vaccination
- Known or suspected immune dysfunction, immunosuppression, or autoimmune disease. Participants with a history of cancer who are not actively treated and not immunosuppressed will be eligible
- Functional or anatomic asplenia
- Received immunoglobulin within 6 months before study vaccine or is planned during the study
- Received any investigational drugs or vaccines within 2 months before study vaccination
- History of pneumococcal disease (positive culture from blood or other normally sterile site)
- Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
- History of convulsion
- Previously diagnosed with immunodeficiency or has a close relative with congenital immune deficiency
- Participating in any other clinical trial
Key Trial Info
Start Date :
October 31 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 9 2015
Estimated Enrollment :
243 Patients enrolled
Trial Details
Trial ID
NCT02260882
Start Date
October 31 2014
End Date
April 9 2015
Last Update
October 30 2018
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