A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
NCT ID: NCT06177912
Last Updated: 2025-03-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
882 participants
INTERVENTIONAL
2024-01-18
2025-02-26
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
TRIPLE
Study Groups
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V116
Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 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 completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment.
Exclusion Criteria
* Has a history of active hepatitis within 3 months before study vaccination
* History of invasive pneumococcal disease within 3 years before study vaccination
2 Years
17 Years
ALL
No
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 0145)
Birmingham, Alabama, United States
Velocity Clinical Research, Phoenix ( Site 0122)
Phoenix, Arizona, United States
Madera Family Medical Group ( Site 0120)
Madera, California, United States
Optumcare Colorado Springs, LLC ( Site 0113)
Colorado Springs, Colorado, United States
Accel Research Sites Network- Nona Pediatric Center ( Site 0109)
Orlando, Florida, United States
University of South Florida-Department of Pediatrics ( Site 0110)
Tampa, Florida, United States
Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128)
Macon, Georgia, United States
Bingham Memorial Hospital ( Site 0149)
Blackfoot, Idaho, United States
Clinical Research Prime ( Site 0105)
Idaho Falls, Idaho, United States
Clinical Research Prime Rexburg ( Site 0104)
Rexburg, Idaho, United States
University of Louisville, Norton Children's Research Institute ( Site 0148)
Louisville, Kentucky, United States
Velocity Clinical Research, Lafayette ( Site 0103)
Lafayette, Louisiana, United States
Velocity Clinical Research, Gulfport ( Site 0115)
Gulfport, Mississippi, United States
Velocity Clinical Research, Hastings ( Site 0114)
Hastings, Nebraska, United States
Midwest Children's Health Research Institute ( Site 0117)
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute ( Site 0106)
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute-Research ( Site 0119)
Lincoln, Nebraska, United States
Midwest Children's Health Research Institute-Research ( Site 0102)
Lincoln, Nebraska, United States
Velocity Clinical Research, Albuquerque ( Site 0112)
Albuquerque, New Mexico, United States
Velocity Clinical Research, Vestal ( Site 0121)
Vestal, New York, United States
Epic Medical Research - Oklahoma ( Site 0134)
Chickasha, Oklahoma, United States
Tribe Clinical Research, LLC-Pediatrics ( Site 0118)
Greenville, South Carolina, United States
Tribe Clinical Research - Spartanburg ( Site 0108)
Spartanburg, South Carolina, United States
Velocity Clinical Research, Austin ( Site 0129)
Austin, Texas, United States
PanAmerican Clinical Research ( Site 0132)
Brownsville, Texas, United States
Epic Medical Research ( Site 0133)
DeSoto, Texas, United States
Epic Medical Research - Mesquite ( Site 0144)
Mesquite, Texas, United States
Alliance for Multispecialty Research, LLC ( Site 0140)
Layton, Utah, United States
Velocity Clinical Research, Salt Lake City ( Site 0124)
West Jordan, Utah, United States
Canadian Center for Vaccinology ( Site 0004)
Halifax, Nova Scotia, Canada
Premier Clinical Trial Network ( Site 0008)
Hamilton, Ontario, Canada
Children's Hospital of Eastern Ontario ( Site 0001)
Ottawa, Ontario, Canada
CHU Sainte-Justine ( Site 0007)
Montreal, Quebec, Canada
McGill University Health Centre - Vaccine Study Centre ( Site 0005)
Pierrefonds, Quebec, Canada
CHU de Québec-Université Laval ( Site 0006)
Québec, Quebec, Canada
Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo)
Santiago, Region M. de Santiago, Chile
Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209)
Santiago, Region M. de Santiago, Chile
Hospital Roberto del Río-Infectología Pediátrica ( Site 0200)
Santiago, Region M. de Santiago, Chile
Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204)
Santiago, Region M. de Santiago, Chile
Hospital Dr. Hernán Henríquez Aravena ( Site 0208)
Temuco, Región de la Araucanía, Chile
Clinica Somer ( Site 0405)
Rionegro, Antioquia, Colombia
Oncomedica S.A.S ( Site 0402)
Montería, Departamento de Córdoba, Colombia
Fundación Valle del Lili ( Site 0404)
Cali, Valle del Cauca Department, Colombia
CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401)
Cali, Valle del Cauca Department, Colombia
FVR, Kokkolan rokotetutkimusklinikka ( Site 0602)
Kokkola, Keski-Pohjanmaa, Finland
FVR, Oulun rokotetutkimusklinikka ( Site 0600)
Oulu, North Ostrobothnia, Finland
FVR, Tampereen rokotetutkimusklinikka ( Site 0603)
Tampere, Pirkanmaa, Finland
FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604)
Seinäjoki, South Ostrobothnia, Finland
FVR, Turun rokotetutkimusklinikka ( Site 0606)
Turku, Southwest Finland, Finland
FVR, Espoon rokotetutkimusklinikka ( Site 0608)
Espoo, Uusimaa, Finland
MeVac - Meilahti Vaccine Research Center ( Site 0609)
Helsinki, Uusimaa, Finland
Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq
Caen, Calvados, France
Hôpital Jeanne de Flandre ( Site 0702)
Lille, Nord, France
Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
Paris, , France
Rambam Health Care Campus ( Site 0900)
Haifa, , Israel
Hadassah Mount Scopus Medical Centre ( Site 0902)
Jerusalem, , Israel
Schneider Children's Medical Center ( Site 0903)
Petah Tikva, , Israel
Saiseikai Yokohamashi Tobu Hospital ( Site 1714)
Yokohama, Kanagawa, Japan
Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701)
Kanegusuku, Okinawa, Japan
Juntendo University Hospital ( Site 1700)
Bunkyo-ku, Tokyo, Japan
Aquakids Clinic ( Site 1709)
Edogawa-ku, Tokyo, Japan
Miyazaki Prefectural Miyazaki Hospital ( Site 1711)
Miyazaki, , Japan
University of Miyazaki Hospital ( Site 1705)
Miyazaki, , Japan
National Hospital Organization Okayama Medical Center ( Site 1713)
Okayama, , Japan
Saitama Prefectural Children's Medical Center ( Site 1702)
Saitama, , Japan
IN VIVO ( Site 1006)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Medyczne Pratia Bydgoszcz ( Site 1004)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc
Wroclaw, Lower Silesian Voivodeship, Poland
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007)
Łomianki, Masovian Voivodeship, Poland
Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005)
Lodz, Łódź Voivodeship, Poland
Hospital Germans Trias i Pujol ( Site 1104)
Badalona, Barcelona, Spain
Hospital Sant Joan de Déu ( Site 1113)
Esplugues de Llobregat, Barcelona, Spain
Hospital Universitari Vall d'Hebron ( Site 1115)
Barcelona, Catalonia, Spain
CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111)
Santiago de Compostela, La Coruna, Spain
Hospital Universitario Severo Ochoa ( Site 1114)
Leganés, Madrid, Spain
Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11
Madrid, , Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112)
Seville, , Spain
CTC Karolinska ( Site 1201)
Solna, Stockholm County, Sweden
Norrlands universitetssjukhus ( Site 1200)
Umeå, Västerbotten County, Sweden
CTC GoCo ( Site 1202)
Mölndal, Västra Götaland County, Sweden
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601)
Bangkoknoi, Bangkok, Thailand
Chulalongkorn University-Pediatrics ( Site 1602)
Pathumwan, Bangkok, Thailand
Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604)
Ratchathewi, Bangkok, Thailand
Songklanagarind hospital-Department of Pediatrics ( Site 1603)
Hat Yai, Changwat Songkhla, Thailand
Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302)
Sarçam, Adana, Turkey (Türkiye)
Hacettepe Universite Hastaneleri ( Site 1300)
Ankara, , Turkey (Türkiye)
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304)
Ankara, , Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301)
Ankara, , Turkey (Türkiye)
Sisli Etfal Training and Research Hospital ( Site 1305)
Istanbul, , Turkey (Türkiye)
Ege Universitesi Hastanesi ( Site 1306)
Izmir, , Turkey (Türkiye)
Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303)
Kayseri, , Turkey (Türkiye)
Countries
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Related Links
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Merck Clinical Trials Information
Plain Language Summary
Other Identifiers
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V116-013
Identifier Type: OTHER
Identifier Source: secondary_id
jRCT2031230559
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-506236-32
Identifier Type: REGISTRY
Identifier Source: secondary_id
U1111-1293-4944
Identifier Type: REGISTRY
Identifier Source: secondary_id
V116-013
Identifier Type: -
Identifier Source: org_study_id
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