A Study to Evaluate the Safety, Tolerability, Immunogenicity, and Lot Consistency of V116 in Adults 18 to 49 Years of Age (V116-004, STRIDE-4)
NCT ID: NCT05464420
Last Updated: 2024-09-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
2162 participants
INTERVENTIONAL
2022-08-12
2023-05-25
Brief Summary
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The primary study hypothesis is that all 3 lots of V116 are equivalent as assessed by the serotype-specific opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs) at 30 days postvaccination for all serotypes included in V116.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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V116 Lot 1
Participants will receive a single 0.5 mL intramuscular (IM) dose of V116 Lot 1 on Day 1.
V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following 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
V116 Lot 2
Participants will receive a single 0.5 mL IM dose of V116 Lot 2 on Day 1.
V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following 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
V116 Lot 3
Participants will receive a single 0.5 mL IM dose of V116 Lot 3 on Day 1.
V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following 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
PPSV23
Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.
PPSV23
Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following 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
Interventions
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V116
Pneumococcal 21-valent conjugate vaccine with 4 μg of each of the following 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
PPSV23
Pneumococcal 23-valent conjugate vaccine with 25 μg of each of the following 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
* Has ability to complete electronic Vaccine Report Card (eVRC) data collection without assistance as per investigator
Exclusion Criteria
* Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
* Has a coagulation disorder contraindicating intramuscular vaccination
* Has a recent illness with fever
* Has a known malignancy that is progressing or has required active treatment \<3 years before enrollment
* Is expected to receive any pneumococcal vaccine during the study outside of the protocol
* Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine
* 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 study vaccine
* Has received any live vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live vaccine ≤30 days after receipt of study vaccine
* Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine
18 Years
49 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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Desert Clinical Research/ CCT Research ( Site 0019)
Mesa, Arizona, United States
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0008)
Tempe, Arizona, United States
Baptist Health Center For Clinical Research ( Site 0015)
Little Rock, Arkansas, United States
Valley Clinical Trials, Inc. ( Site 0023)
Northridge, California, United States
Artemis Institute for Clinical Research ( Site 0027)
San Diego, California, United States
Millennium Clinical Trials ( Site 0004)
Simi Valley, California, United States
Diablo Clinical Research, Inc. ( Site 0022)
Walnut Creek, California, United States
Lynn Institute of Denver ( Site 0003)
Aurora, Colorado, United States
Indago Research & Health Center, Inc ( Site 0011)
Hialeah, Florida, United States
L&C Professional Medical Research Institute ( Site 0012)
Miami, Florida, United States
Headlands Research Orlando ( Site 0017)
Orlando, Florida, United States
Clinical Research Trials of Florida ( Site 0001)
Tampa, Florida, United States
Clinical Research Prime Rexburg ( Site 0040)
Rexburg, Idaho, United States
Healthcare Research Network - Chicago ( Site 0006)
Flossmoor, Illinois, United States
Kentucky Pediatric/ Adult Research ( Site 0036)
Bardstown, Kentucky, United States
Alliance for Multispecialty Research, LLC ( Site 0031)
Kansas City, Missouri, United States
Methodist Physicians Clinic/CCT Research ( Site 0029)
Fremont, Nebraska, United States
Healor Primary Care / CCT Research ( Site 0028)
Las Vegas, Nevada, United States
Axces Research ( Site 0034)
Santa Fe, New Mexico, United States
Rochester Clinical Research, Inc. ( Site 0033)
Rochester, New York, United States
M3 Wake Research Associates ( Site 0035)
Raleigh, North Carolina, United States
Lynn Health Science Institute ( Site 0014)
Oklahoma City, Oklahoma, United States
Velocity Clinical Research, Providence ( Site 0018)
East Greenwich, Rhode Island, United States
Velocity Clinical Research, Greenville ( Site 0021)
Greenville, South Carolina, United States
Clinical Research Associates Inc ( Site 0039)
Nashville, Tennessee, United States
DCOL Center for Clinical Research ( Site 0025)
Longview, Texas, United States
IMA Clinical Research San Antonio ( Site 0020)
San Antonio, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research ( Site 0016)
Tomball, Texas, United States
Charlottesville Medical Research ( Site 0013)
Charlottesville, Virginia, United States
Health Research of Hampton Roads, Inc. ( Site 0002)
Newport News, Virginia, United States
Medizinische Universität Graz-Klinische Abteilung für Pulmonologie ( Site 0304)
Graz, Styria, Austria
Medizinische Universitaet Innsbruck ( Site 0301)
Innsbruck, Tyrol, Austria
Tropeninstitut Wien 1060 ( Site 0300)
Vienna, Vienna, Austria
Medizinische Universität Wien ( Site 0302)
Vienna, , Austria
Colchester Research Group ( Site 0202)
Truro, Nova Scotia, Canada
Hamilton Medical Research Group ( Site 0208)
Hamilton, Ontario, Canada
Milestone Research Inc. ( Site 0201)
London, Ontario, Canada
Manna Research Toronto ( Site 0209)
Toronto, Ontario, Canada
Manna Research Mirabel ( Site 0207)
Mirabel, Quebec, Canada
Manna Research Montreal ( Site 0203)
Pointe-Claire, Quebec, Canada
Q&T Research Sherbrooke Inc. ( Site 0204)
Sherbrooke, Quebec, Canada
Diex Recherche Trois-Rivieres ( Site 0206)
Trois-Rivières, Quebec, Canada
Sanos Clinic-Sanos Clinic ( Site 0402)
Herlev, Capital Region, Denmark
Danske Lægers Vaccinations Service - Søborg ( Site 0404)
Søborg, Capital Region, Denmark
Danske Lægers Vaccinations Service - Århus ( Site 0403)
Aarhus, Central Jutland, Denmark
Sanos Clinic - Nordjylland ( Site 0401)
Aalborg, North Denmark, Denmark
Sanos Clinic - Syddanmark ( Site 0400)
Vejle, Region Syddanmark, Denmark
FVR, Oulun rokotetutkimusklinikka ( Site 0501)
Oulu, North Ostrobothnia, Finland
FVR, Porin rokotetutkimusklinikka ( Site 0508)
Pori, Satakunta, Finland
FVR, Seinäjoen rokotetutkimusklinikka ( Site 0504)
Seinäjoki, South Ostrobothnia, Finland
FVR, Turun rokotetutkimusklinikka ( Site 0500)
Turku, Southwest Finland, Finland
FVR, Espoon rokotetutkimusklinikka ( Site 0509)
Espoo, Uusimaa, Finland
FVR, Etelä-Helsingin rokotetutkimusklinikka ( Site 0503)
Helsinki, Uusimaa, Finland
Helsinki East Vaccine Research Clinic ( Site 0502)
Helsinki, Uusimaa, Finland
Rambam Health Care Campus ( Site 0603)
Haifa, , Israel
Maccabi Healthcare Services ( Site 0606)
Jerusalem, , Israel
Hadassah Medical Center ( Site 0600)
Jerusalem, , Israel
Meir Medical Center ( Site 0601)
Kfar Saba, , Israel
Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0604)
Ramat Gan, , Israel
Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0602)
Sakhnin, , Israel
IN VIVO ( Site 0711)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne Pratia Bydgoszcz-Centrum Medyczne Pratia Bydgoszcz ( Site 0709)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
MICS Centrum Medyczne Torun ( Site 0706)
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Alergotest s.c Specjalistyczne Centrum Medyczne ( Site 0703)
Lublin, Lublin Voivodeship, Poland
Centrum Medyczne Medyk ( Site 0704)
Rzeszów, Podkarpackie Voivodeship, Poland
Clinmedica OMC ( Site 0701)
Skierniewice, Łódź Voivodeship, Poland
EBA CENTELLES ( Site 0800)
Centelles, Catalonia, Spain
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0808)
Pozuelo de Alarcón, Madrid, Spain
Fundación Oftalmologica del Mediterraneo-Vaccine Research ( Site 0818)
Valencia, Valenciana, Comunitat, Spain
Centre d'Atenció Primària Vallcarca - Sant Gervasi ( Site 0801)
Barcelona, , Spain
EAP Sardenya ( Site 0802)
Barcelona, , Spain
Hospital La Princesa-Clinical Pharmacology ( Site 0815)
Madrid, , Spain
Countries
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References
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Scott P, Ukkonen B, Caraco Y, Perez SN, Alpizar SA, Cardona JF, Greenberg D, Grijalva CG, Orenstein W, Wiedmann RT, Fernsler D, Cheon K, Li J, Platt HL. A phase 3, randomized trial to evaluate lot-to-lot consistency of V116, an adult-specific pneumococcal conjugate vaccine (STRIDE-4). Med. 2025 Jun 18:100748. doi: 10.1016/j.medj.2025.100748. Online ahead of print.
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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2022-000265-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
V116-004
Identifier Type: -
Identifier Source: org_study_id
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