EICHORCondition: Pneumonia, Pneumococcal · Sponsor: Merck Sharp & Dohme LLC
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This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
This description comes directly from the study's public registry record.
No contact information is available for this study as per the public registry record.
Always discuss trial participation with your own doctor first.
The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: * Has received pneumococcal vaccine \>= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23). Exclusion Criteria: * Has a history of invasive pneumococcal disease (IPD). * Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, including diphtheria toxoid. * Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease. * Has a coagulation disorder contraindicating intramuscular vaccination. * Has a known malignancy that is progressing or has required active treatment. * Has received PPSV23 followed by either PCV15 or PCV20. * Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day). * Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. * Has received any non-live vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine. * Has received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine. * Has received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 post-vaccination blood draw is complete.
Reproduced word-for-word from the public registry record — the study team can answer questions about it.
| Central Research Associates ( Site 0024) | Birmingham, Alabama, United States | — |
| Lenzmeier Family Medicine/CCT Research ( Site 0008) | Glendale, Arizona, United States | — |
| Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006) | Tempe, Arizona, United States | — |
| Southland Clinical Research Center ( Site 0026) | Fountain Valley, California, United States | — |
| Diablo Clinical Research, Inc. ( Site 0019) | Walnut Creek, California, United States | — |
| Alliance for Multispecialty Research, LLC ( Site 0020) | Coral Gables, Florida, United States | — |
| Indago Research & Health Center, Inc ( Site 0005) | Hialeah, Florida, United States | — |
| Advanced Medical Research Institute ( Site 0018) | Miami, Florida, United States | — |
| Solaris Clinical Research ( Site 0025) | Meridian, Idaho, United States | — |
| Centennial Medical Group ( Site 0002) | Elkridge, Maryland, United States | — |
| Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016) | Troy, Michigan, United States | — |
| Meridian Clinical Research, LLC ( Site 0009) | Norfolk, Nebraska, United States | — |
+ 39 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05420961