A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
- Registration Number
- NCT06177912
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 882
- Has a diagnosis and stable medical management (for at least 3 months) of one of the following risk conditions for pneumococcal disease: Diabetes mellitus, chronic compensated liver disease, chronic lung disease, chronic heart disease, or chronic kidney disease.
- Has completed pneumococcal conjugate vaccine regimen (PCV7, PCV10, or PCV13) at least 8 weeks before study enrollment.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V116 V116 Participants will receive a single 0.5 mL intramuscular (IM) injection of V116 on Day 1 PPSV23 PPSV23 Participants will receive a single 0.5 mL IM dose of PPSV23 on Day 1.
- Primary Outcome Measures
Name Time Method Percentage of participants with vaccine-related serious adverse events (SAEs) Up to approximately 6 months A vaccine-related SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is another important medical event.
Percentage of participants with solicited injection-site adverse events (AEs) Up to 5 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs include pain/tenderness, redness/erythema, and swelling.
Percentage of participants with solicited systemic AEs Up to 5 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs include headache, muscle aches/myalgia, and tiredness/fatigue.
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses 30 days postvaccination Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA)
- Secondary Outcome Measures
Name Time Method Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs Baseline (Day 1) and Day 30 postvaccination The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA.
Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs GMTs Baseline (Day 1) and Day 30 postvaccination The percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs will be determined with MOPA.
GMFR from baseline in serotype-specific IgG GMCs Baseline (Day 1) and Day 30 postvaccination The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL.
Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs Baseline (Day 1) and Day 30 postvaccination The percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs will be determined using PnECL.
Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination 30 days postvaccination The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL)
Trial Locations
- Locations (92)
Premier Clinical Trial Network ( Site 0008)
🇨🇦Hamilton, Ontario, Canada
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
Children's Hospital of Eastern Ontario ( Site 0001)
🇨🇦Ottawa, Ontario, Canada
CHU Sainte-Justine ( Site 0007)
🇨🇦Montréal, Quebec, Canada
McGill University Health Centre - Vaccine Study Centre ( Site 0005)
🇨🇦Pierrefonds, Quebec, Canada
CHU de Québec-Université Laval ( Site 0006)
🇨🇦Quebec City, Quebec, Canada
Hospital Dr. Hernán Henríquez Aravena ( Site 0208)
🇨🇱Temuco, Araucania, Chile
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
University of Miyazaki Hospital ( Site 1705)
🇯🇵Miyazaki, Japan
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
Clinica Somer ( Site 0405)
🇨🇴Rionegro, Antioquia, Colombia
Oncomedica S.A.S ( Site 0402)
🇨🇴Montería, Cordoba, Colombia
Fundación Valle del Lili ( Site 0404)
🇨🇴Cali, Valle Del Cauca, Colombia
CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401)
🇨🇴Cali, Valle Del Cauca, Colombia
FVR, Kokkolan rokotetutkimusklinikka ( Site 0602)
🇫🇮Kokkola, Mellersta Osterbotten, Finland
FVR, Tampereen rokotetutkimusklinikka ( Site 0603)
🇫🇮Tampere, Pirkanmaa, Finland
FVR, Oulun rokotetutkimusklinikka ( Site 0600)
🇫🇮Oulu, Pohjois-Pohjanmaa, Finland
FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604)
🇫🇮Seinäjoki, Sodra Osterbotten, Finland
FVR, Espoon rokotetutkimusklinikka ( Site 0608)
🇫🇮Espoo, Uusimaa, Finland
MeVac - Meilahti Vaccine Research Center ( Site 0609)
🇫🇮Helsinki, Uusimaa, Finland
FVR, Turun rokotetutkimusklinikka ( Site 0606)
🇫🇮Turku, Varsinais-Suomi, 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)
🇯🇵Haebaru, 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
National Hospital Organization Okayama Medical Center ( Site 1713)
🇯🇵Okayama, Japan
Saitama Prefectural Children's Medical Center ( Site 1702)
🇯🇵Saitama, Japan
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc
🇵🇱Wroclaw, Dolnoslaskie, Poland
IN VIVO ( Site 1006)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Centrum Medyczne Pratia Bydgoszcz ( Site 1004)
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005)
🇵🇱Lodz, Lodzkie, Poland
SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007)
🇵🇱Lomianki, Mazowieckie, 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, Cataluna, Spain
CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111)
🇪🇸Santiago de Compostela, La Coruna, Spain
Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105)
🇪🇸Madrid, Madrid, Comunidad De, Spain
Hospital Universitario Severo Ochoa ( Site 1114)
🇪🇸Leganés, Madrid, Spain
Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11
🇪🇸Madrid, Spain
HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112)
🇪🇸Sevilla, Spain
CTC Karolinska ( Site 1201)
🇸🇪Solna, Stockholms Lan, Sweden
Norrlands universitetssjukhus ( Site 1200)
🇸🇪Umeå, Vasterbottens Lan, Sweden
CTC GoCo ( Site 1202)
🇸🇪Mölndal, Vastra Gotalands Lan, Sweden
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601)
🇹🇭Bangkoknoi, Krung Thep Maha Nakhon, Thailand
Chulalongkorn University-Pediatrics ( Site 1602)
🇹🇭Pathumwan, Krung Thep Maha Nakhon, Thailand
Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604)
🇹🇭Ratchathewi, Krung Thep Maha Nakhon, Thailand
Songklanagarind hospital-Department of Pediatrics ( Site 1603)
🇹🇭Hat Yai, Songkhla, Thailand
Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302)
🇹🇷Sarçam, Adana, Turkey
Hacettepe Universite Hastaneleri ( Site 1300)
🇹🇷Ankara, Turkey
Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304)
🇹🇷Ankara, Turkey
Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301)
🇹🇷Ankara, Turkey
Sisli Etfal Training and Research Hospital ( Site 1305)
🇹🇷Istanbul, Turkey
Ege Universitesi Hastanesi ( Site 1306)
🇹🇷İzmir, Turkey
Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303)
🇹🇷Kayseri, Turkey