A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

Completed · Phase 3

Conditions studied: Pneumonia, Pneumococcal

In brief

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.

Key facts

Study ID

NCT05420961

Run by

Merck Sharp & Dohme LLC

People needed

717

Starts

2022-07-12

Expected to finish

2023-05-16

Last updated by the study team

2024-10-26

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23).

You may not qualify if…

• 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.

Where it is running

• 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
• Advanced Medical Research ( Site 0001) — Maumee, Ohio, United States
• University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si — Galveston, Texas, United States
• Health Research of Hampton Roads, Inc. ( Site 0003) — Newport News, Virginia, United States
• Hamilton Medical Research Group ( Site 0114) — Hamilton, Ontario, Canada
• Milestone Research Inc. ( Site 0104) — London, Ontario, Canada
• Manna Research Mirabel ( Site 0109) — Mirabel, Quebec, Canada
• CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120) — Québec, Quebec, Canada
• Diex Recherche Sherbrooke Inc. ( Site 0101) — Sherbrooke, Quebec, Canada
• CHU Bordeaux Haut-Leveque ( Site 0202) — Pessac, Aquitaine, France
• CHRU de Brest ( Site 0200) — Brest, Finistere, France
• centre hospitalier lyon sud ( Site 0204) — Pierre-Bénite, Rhone, France
• Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203) — Paris, France
• Rambam Health Care Campus ( Site 0303) — Haifa, Israel
• Central Research Associates ( Site 0024) — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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