A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)

Last updated: March 19, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

3

Condition

Pneumococcal Disease

Treatment

V116

PPSV23

Clinical Study ID

NCT06177912
V116-013
2023-506236-32
jRCT2031230559
V116-013
U1111-1293-4944
  • Ages 2-17
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of V116 compared to PPSV23 in children 2 through 17 years of age. Researchers want to learn if V116 is as good as, or is better than the PPSV23 vaccine in terms of the antibody immune response. V116 and PPSV23 will be studied in children and teenagers who have a higher risk of getting invasive pneumococcal disease (IPD).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Has a diagnosis and stable medical management (for at least 3 months) of one of thefollowing risk conditions for pneumococcal disease: Diabetes mellitus, chroniccompensated liver disease, chronic lung disease, chronic heart disease, or chronickidney disease.

  • Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) atleast 8 weeks before study enrollment.

Exclusion

Exclusion Criteria:

  • Has previously received PPSV23 vaccine

  • Has a history of active hepatitis within 3 months before study vaccination

  • History of invasive pneumococcal disease within 3 years before study vaccination

Study Design

Total Participants: 882
Treatment Group(s): 2
Primary Treatment: V116
Phase: 3
Study Start date:
January 18, 2024
Estimated Completion Date:
February 26, 2025

Connect with a study center

  • Canadian Center for Vaccinology ( Site 0004)

    Halifax, Nova Scotia B3K6R8
    Canada

    Site Not Available

  • Hamilton Medical Research Group ( Site 0008)

    Hamilton, Ontario L8M 1K7
    Canada

    Site Not Available

  • Premier Clinical Trial Network ( Site 0008)

    Hamilton, Ontario L8L 5G4
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario ( Site 0001)

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • CHU Sainte-Justine ( Site 0007)

    Montréal, Quebec H3T 1C5
    Canada

    Site Not Available

  • McGill University Health Centre - Vaccine Study Centre ( Site 0005)

    Pierrefonds, Quebec H9H 4Y6
    Canada

    Site Not Available

  • CHU de Québec-Université Laval ( Site 0006)

    Quebec City, Quebec G1E 7G9
    Canada

    Site Not Available

  • Hospital Dr. Hernán Henríquez Aravena ( Site 0208)

    Temuco, Araucania 4781151
    Chile

    Site Not Available

  • Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo)

    Santiago, Region M. De Santiago 7590943
    Chile

    Site Not Available

  • Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204)

    Santiago, Region M. De Santiago 8880465
    Chile

    Site Not Available

  • Hospital Roberto del Río-Infectología Pediátrica ( Site 0200)

    Santiago, Region M. De Santiago 8380418
    Chile

    Site Not Available

  • Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209)

    Santiago, Region M. De Santiago 8330077
    Chile

    Site Not Available

  • Clinica Somer ( Site 0405)

    Rionegro, Antioquia 054040
    Colombia

    Site Not Available

  • Oncomedica S.A.S ( Site 0402)

    Montería, Cordoba 230001
    Colombia

    Site Not Available

  • Oncomédica S.A.S-Oncomedica S.A ( Site 0402)

    Montería, Cordoba 230001
    Colombia

    Active - Recruiting

  • CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401)

    Cali, Valle Del Cauca 760042
    Colombia

    Site Not Available

  • Fundación Valle del Lili ( Site 0404)

    Cali, Valle Del Cauca 760032
    Colombia

    Site Not Available

  • FVR, Kokkolan rokotetutkimusklinikka ( Site 0602)

    Kokkola, Mellersta Osterbotten 67100
    Finland

    Site Not Available

  • FVR, Tampereen rokotetutkimusklinikka ( Site 0603)

    Tampere, Pirkanmaa 33100
    Finland

    Site Not Available

  • FVR, Oulun rokotetutkimusklinikka ( Site 0600)

    Oulu, Pohjois-Pohjanmaa 90220
    Finland

    Site Not Available

  • FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604)

    Seinäjoki, Sodra Osterbotten 60100
    Finland

    Site Not Available

  • FVR, Espoon rokotetutkimusklinikka ( Site 0608)

    Espoo, Uusimaa 02230
    Finland

    Site Not Available

  • MeVac - Meilahti Vaccine Research Center ( Site 0609)

    Helsinki, Uusimaa 00290
    Finland

    Site Not Available

  • FVR, Turun rokotetutkimusklinikka ( Site 0606)

    Turku, Varsinais-Suomi 20520
    Finland

    Site Not Available

  • Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq

    Caen, Calvados 14033
    France

    Site Not Available

  • Hôpital Jeanne de Flandre ( Site 0702)

    Lille, Nord 59037
    France

    Site Not Available

  • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita

    Paris, 75019
    France

    Site Not Available

  • Rambam Health Care Campus ( Site 0900)

    Haifa, 3109601
    Israel

    Site Not Available

  • Hadassah Mount Scopus Medical Centre ( Site 0902)

    Jerusalem, 9124001
    Israel

    Site Not Available

  • Schneider Children's Medical Center ( Site 0903)

    Petah-Tikva, 4920235
    Israel

    Site Not Available

  • Saiseikai Yokohamashi Tobu Hospital ( Site 1714)

    Yokohama, Kanagawa 230-0012
    Japan

    Site Not Available

  • Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701)

    Haebaru, Okinawa 901-1193
    Japan

    Site Not Available

  • Juntendo University Hospital ( Site 1700)

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Site Not Available

  • Aquakids Clinic ( Site 1709)

    Edogawa-ku, Tokyo 133-0056
    Japan

    Site Not Available

  • Miyazaki Prefectural Miyazaki Hospital ( Site 1711)

    Miyazaki, 880-8510
    Japan

    Site Not Available

  • University of Miyazaki Hospital ( Site 1705)

    Miyazaki, 889-1692
    Japan

    Site Not Available

  • National Hospital Organization Okayama Medical Center ( Site 1713)

    Okayama, 701-1192
    Japan

    Site Not Available

  • Saitama Prefectural Children's Medical Center ( Site 1702)

    Saitama, 330-8777
    Japan

    Site Not Available

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc

    Wroclaw, Dolnoslaskie 50-368
    Poland

    Site Not Available

  • Centrum Medyczne Pratia Bydgoszcz ( Site 1004)

    Bydgoszcz, Kujawsko-pomorskie 85-796
    Poland

    Site Not Available

  • IN VIVO ( Site 1006)

    Bydgoszcz, Kujawsko-pomorskie 85-048
    Poland

    Site Not Available

  • Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005)

    Lodz, Lodzkie 91-347
    Poland

    Site Not Available

  • SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007)

    Lomianki, Mazowieckie 05-092
    Poland

    Site Not Available

  • Hospital Germans Trias i Pujol ( Site 1104)

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Hospital Sant Joan de Déu ( Site 1113)

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • Hospital Universitari Vall d'Hebron ( Site 1115)

    Barcelona, Cataluna 08035
    Spain

    Site Not Available

  • CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111)

    Santiago de Compostela, La Coruna 15706
    Spain

    Site Not Available

  • Hospital Universitario Severo Ochoa ( Site 1114)

    Leganés, Madrid 28911
    Spain

    Site Not Available

  • Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105)

    Madrid, Madrid, Comunidad De 28046
    Spain

    Site Not Available

  • Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11

    Madrid, 28041
    Spain

    Site Not Available

  • HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112)

    Sevilla, 41013
    Spain

    Site Not Available

  • CTC Karolinska ( Site 1201)

    Solna, Stockholms Lan 171 64
    Sweden

    Site Not Available

  • Norrlands universitetssjukhus ( Site 1200)

    Umeå, Vasterbottens Lan 901 85
    Sweden

    Site Not Available

  • CTC GoCo ( Site 1202)

    Mölndal, Vastra Gotalands Lan 431 53
    Sweden

    Site Not Available

  • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601)

    Bangkoknoi, Krung Thep Maha Nakhon 10700
    Thailand

    Site Not Available

  • Chulalongkorn University-Pediatrics ( Site 1602)

    Pathumwan, Krung Thep Maha Nakhon 10330
    Thailand

    Site Not Available

  • Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604)

    Ratchathewi, Krung Thep Maha Nakhon 10400
    Thailand

    Site Not Available

  • Songklanagarind hospital-Department of Pediatrics ( Site 1603)

    Hat Yai, Songkhla 90110
    Thailand

    Site Not Available

  • Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302)

    Sarçam, Adana 01250
    Turkey

    Site Not Available

  • Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301)

    Ankara, 06800
    Turkey

    Site Not Available

  • Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304)

    Ankara, 06590
    Turkey

    Site Not Available

  • Hacettepe Universite Hastaneleri ( Site 1300)

    Ankara, 06230
    Turkey

    Site Not Available

  • Sisli Etfal Training and Research Hospital ( Site 1305)

    Istanbul, 34360
    Turkey

    Site Not Available

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303)

    Kayseri, 38039
    Turkey

    Site Not Available

  • Ege Universitesi Hastanesi ( Site 1306)

    İzmir, 35100
    Turkey

    Site Not Available

  • Central Research Associates ( Site 0145)

    Birmingham, Alabama 35205
    United States

    Site Not Available

  • Velocity Clinical Research, Phoenix ( Site 0122)

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • Madera Family Medical Group ( Site 0120)

    Madera, California 93637
    United States

    Site Not Available

  • Optumcare Colorado Springs, LLC ( Site 0113)

    Colorado Springs, Colorado 80922
    United States

    Site Not Available

  • Accel Research Sites Network- Nona Pediatric Center ( Site 0109)

    Orlando, Florida 32829
    United States

    Site Not Available

  • University of South Florida-Department of Pediatrics ( Site 0110)

    Tampa, Florida 33606
    United States

    Site Not Available

  • Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128)

    Macon, Georgia 31210
    United States

    Site Not Available

  • Bingham Memorial Hospital ( Site 0149)

    Blackfoot, Idaho 83221
    United States

    Site Not Available

  • Clinical Research Prime ( Site 0105)

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • Clinical Research Prime Rexburg ( Site 0104)

    Rexburg, Idaho 83440
    United States

    Site Not Available

  • University of Louisville, Norton Children's Research Institute ( Site 0148)

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Velocity Clinical Research, Lafayette ( Site 0103)

    Lafayette, Louisiana 70508
    United States

    Site Not Available

  • Velocity Clinical Research, Gulfport ( Site 0115)

    Gulfport, Mississippi 39503
    United States

    Site Not Available

  • Velocity Clinical Research, Hastings ( Site 0114)

    Hastings, Nebraska 68901
    United States

    Site Not Available

  • Midwest Children's Health Research Institute ( Site 0106)

    Lincoln, Nebraska 68505
    United States

    Site Not Available

  • Midwest Children's Health Research Institute ( Site 0117)

    Lincoln, Nebraska 68504
    United States

    Site Not Available

  • Midwest Children's Health Research Institute-Research ( Site 0102)

    Lincoln, Nebraska 68522
    United States

    Site Not Available

  • Midwest Children's Health Research Institute-Research ( Site 0119)

    Lincoln, Nebraska 68516
    United States

    Site Not Available

  • Velocity Clinical Research, Albuquerque ( Site 0112)

    Albuquerque, New Mexico 87107
    United States

    Site Not Available

  • Velocity Clinical Research, Vestal ( Site 0121)

    Vestal, New York 13850
    United States

    Site Not Available

  • Epic Medical Research - Oklahoma ( Site 0134)

    Chickasha, Oklahoma 73018
    United States

    Site Not Available

  • Tribe Clinical Research, LLC-Pediatrics ( Site 0118)

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Tribe Clinical Research - Spartanburg ( Site 0108)

    Spartanburg, South Carolina 29301
    United States

    Site Not Available

  • Velocity Clinical Research, Austin ( Site 0129)

    Austin, Texas 78759
    United States

    Site Not Available

  • PanAmerican Clinical Research ( Site 0132)

    Brownsville, Texas 78521
    United States

    Site Not Available

  • Valley Regional Medical Center Clinical Lab ( Site 0132)

    Brownsville, Texas 78526
    United States

    Site Not Available

  • Epic Medical Research ( Site 0133)

    DeSoto, Texas 75115
    United States

    Site Not Available

  • Epic Medical Research - Mesquite ( Site 0144)

    Mesquite, Texas 75150
    United States

    Site Not Available

  • Alliance for Multispecialty Research, LLC ( Site 0140)

    Layton, Utah 84041
    United States

    Site Not Available

  • Velocity Clinical Research, Salt Lake City ( Site 0124)

    West Jordan, Utah 84088
    United States

    Site Not Available

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