A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)
NCT ID: NCT05420961
Last Updated: 2024-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
717 participants
INTERVENTIONAL
2022-07-12
2023-05-16
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
DOUBLE
Study Groups
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Cohort 1: V116
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Cohort 1: PCV15
Participants will receive a single 0.5 mL IM injection of PCV15 on Day 1. Participants in this arm received PPSV23 prior to the enrollment.
PCV15
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension
Cohort 2: V116
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Cohort 2: PPSV23
Participants will receive a single 0.5 mL IM injection of PPSV23 on Day 1. Participants in this arm received PCV13 prior to the enrollment.
PPSV23
Pneumococcal 23-valent vaccine with 25 μg of each of the PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Cohort 3: V116
Participants will receive a single 0.5 mL IM injection of V116 on Day 1. Participants in this arm received PCV15, PCV20, PCV13+PPSV23, PCV15+PPSV23, or PPSV23+PCV13 prior to the enrollment.
V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
Interventions
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V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution
PCV15
Pneumococcal 15-valent conjugate vaccine with 2 μg of each of the PnPs antigen: 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, and 4 μg of 6B in each 0.5 mL sterile suspension
PPSV23
Pneumococcal 23-valent vaccine with 25 μg of each of the PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
50 Years
ALL
Yes
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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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
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
Maccabi Health Services - Holon ( Site 0305)
Holon, , Israel
Maccabi Healthcare Services ( Site 0306)
Jerusalem, , Israel
Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300)
Jerusalem, , Israel
Meir Medical Center ( Site 0301)
Kfar Saba, , Israel
Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304)
Ramat Gan, , Israel
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302)
Sakhnin, , Israel
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400)
Milan, Lombardy, Italy
Ospedale San Raffaele ( Site 0403)
Milan, Lombardy, Italy
A.O.U. Policlinico Paolo Giaccone ( Site 0402)
Palermo, Sicily, Italy
Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405)
Foggia, , Italy
PS Clinic ( Site 0700)
Fukuoka, , Japan
Nishikumamoto Hospital ( Site 0701)
Kumamoto, , Japan
Gachon University Gil Medical Center ( Site 0755)
Namdong-gu, Incheon, South Korea
Korea University Ansan Hospital ( Site 0751)
Ansan-si, Kyonggi-do, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752)
Seoul, , South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753)
Seoul, , South Korea
Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754)
Seoul, , South Korea
Korea University Guro Hospital ( Site 0750)
Seoul, , South Korea
HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503)
Barcelona, Catalonia, Spain
EBA CENTELLES ( Site 0500)
Centelles, Catalonia, Spain
Hospital Universitari de Bellvitge ( Site 0505)
L'Hospitalet de Llobregat, Catalonia, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508)
Pozuelo de Alarcón, Madrid, Spain
Hospital Internacional Xanit ( Site 0520)
Benalmádena, Malaga, Spain
Hospital La Princesa ( Site 0515)
Madrid, , Spain
National Cheng Kung University Hospital ( Site 0801)
Tainan City, , Taiwan
National Taiwan University Hospital ( Site 0800)
Taipei, , Taiwan
Countries
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References
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Scott P, Haranaka M, Choi JH, Stacey H, Dionne M, Greenberg D, Grijalva CG, Orenstein WA, Fernsler D, Gallagher N, Zeng T, Li J, Platt HL; STRIDE-6 Study Group. A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older (STRIDE-6). Clin Infect Dis. 2024 Dec 17;79(6):1366-1374. doi: 10.1093/cid/ciae383.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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jRCT2071220025
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-006679-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V116-006
Identifier Type: -
Identifier Source: org_study_id
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