Clinical trial NCT06177912: A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)
Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Children and Adolescents With Increased Risk of Pneumococcal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2023-12-20
Enrollment: 882
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility criteria: Inclusion Criteria:

* 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.

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

Primary outcomes:
measure: Percentage of participants with solicited injection-site adverse events (AEs)
timeFrame: Up to 5 days
measure: Percentage of participants with solicited systemic AEs
timeFrame: Up to 5 days
measure: Percentage of participants with vaccine-related serious adverse events (SAEs)
timeFrame: Up to approximately 6 months
measure: Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
timeFrame: 30 days postvaccination
Secondary outcomes:
measure: Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination
timeFrame: 30 days postvaccination
measure: Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs GMTs
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: GMFR from baseline in serotype-specific IgG GMCs
timeFrame: Baseline (Day 1) and Day 30 postvaccination
measure: Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs
timeFrame: Baseline (Day 1) and Day 30 postvaccination
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Central Research Associates ( Site 0145)
state: Alabama
city: Phoenix
country: United States
facility: Velocity Clinical Research, Phoenix ( Site 0122)
state: Arizona
city: Madera
country: United States
facility: Madera Family Medical Group ( Site 0120)
state: California
city: Colorado Springs
country: United States
facility: Optumcare Colorado Springs, LLC ( Site 0113)
state: Colorado
city: Orlando
country: United States
facility: Accel Research Sites Network- Nona Pediatric Center ( Site 0109)
state: Florida
city: Tampa
country: United States
facility: University of South Florida-Department of Pediatrics ( Site 0110)
state: Florida
city: Macon
country: United States
facility: Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128)
state: Georgia
city: Blackfoot
country: United States
facility: Bingham Memorial Hospital ( Site 0149)
state: Idaho
city: Idaho Falls
country: United States
facility: Clinical Research Prime ( Site 0105)
state: Idaho
city: Rexburg
country: United States
facility: Clinical Research Prime Rexburg ( Site 0104)
state: Idaho
city: Louisville
country: United States
facility: University of Louisville, Norton Children's Research Institute ( Site 0148)
state: Kentucky
city: Lafayette
country: United States
facility: Velocity Clinical Research, Lafayette ( Site 0103)
state: Louisiana
city: Gulfport
country: United States
facility: Velocity Clinical Research, Gulfport ( Site 0115)
state: Mississippi
city: Hastings
country: United States
facility: Velocity Clinical Research, Hastings ( Site 0114)
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute ( Site 0117)
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute ( Site 0106)
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute-Research ( Site 0119)
state: Nebraska
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute-Research ( Site 0102)
state: Nebraska
city: Albuquerque
country: United States
facility: Velocity Clinical Research, Albuquerque ( Site 0112)
state: New Mexico
city: Vestal
country: United States
facility: Velocity Clinical Research, Vestal ( Site 0121)
state: New York
city: Chickasha
country: United States
facility: Epic Medical Research - Oklahoma ( Site 0134)
state: Oklahoma
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC-Pediatrics ( Site 0118)
state: South Carolina
city: Spartanburg
country: United States
facility: Tribe Clinical Research - Spartanburg ( Site 0108)
state: South Carolina
city: Austin
country: United States
facility: Velocity Clinical Research, Austin ( Site 0129)
state: Texas
city: Brownsville
country: United States
facility: PanAmerican Clinical Research ( Site 0132)
state: Texas
city: DeSoto
country: United States
facility: Epic Medical Research ( Site 0133)
state: Texas
city: Mesquite
country: United States
facility: Epic Medical Research - Mesquite ( Site 0144)
state: Texas
city: Layton
country: United States
facility: Alliance for Multispecialty Research, LLC ( Site 0140)
state: Utah
city: West Jordan
country: United States
facility: Velocity Clinical Research, Salt Lake City ( Site 0124)
state: Utah
city: Halifax
country: Canada
facility: Canadian Center for Vaccinology ( Site 0004)
state: Nova Scotia
city: Hamilton
country: Canada
facility: Premier Clinical Trial Network ( Site 0008)
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario ( Site 0001)
state: Ontario
city: Montréal
country: Canada
facility: CHU Sainte-Justine ( Site 0007)
state: Quebec
city: Pierrefonds
country: Canada
facility: McGill University Health Centre - Vaccine Study Centre ( Site 0005)
state: Quebec
city: Quebec City
country: Canada
facility: CHU de Québec-Université Laval ( Site 0006)
state: Quebec
city: Temuco
country: Chile
facility: Hospital Dr. Hernán Henríquez Aravena ( Site 0208)
state: Araucania
city: Santiago
country: Chile
facility: Centro de Estudios Clínicos (ICIM, Facultad de Medicina Clínica Alemana Universidad del Desarrollo)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Pediatric Infectious Diseases and Immunology ( Site 0209)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Hospital Roberto del Río-Infectología Pediátrica ( Site 0200)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Hospital Padre Hurtado-NEONATOLOGY/PEDIATRICS ( Site 0204)
state: Region M. De Santiago
city: Rionegro
country: Colombia
facility: Clinica Somer ( Site 0405)
state: Antioquia
city: Montería
country: Colombia
facility: Oncomedica S.A.S ( Site 0402)
state: Cordoba
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0404)
state: Valle Del Cauca
city: Cali
country: Colombia
facility: CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401)
state: Valle Del Cauca
city: Kokkola
country: Finland
facility: FVR, Kokkolan rokotetutkimusklinikka ( Site 0602)
state: Mellersta Osterbotten
city: Tampere
country: Finland
facility: FVR, Tampereen rokotetutkimusklinikka ( Site 0603)
state: Pirkanmaa
city: Oulu
country: Finland
facility: FVR, Oulun rokotetutkimusklinikka ( Site 0600)
state: Pohjois-Pohjanmaa
city: Seinäjoki
country: Finland
facility: FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604)
state: Sodra Osterbotten
city: Espoo
country: Finland
facility: FVR, Espoon rokotetutkimusklinikka ( Site 0608)
state: Uusimaa
city: Helsinki
country: Finland
facility: MeVac - Meilahti Vaccine Research Center ( Site 0609)
state: Uusimaa
city: Turku
country: Finland
facility: FVR, Turun rokotetutkimusklinikka ( Site 0606)
state: Varsinais-Suomi
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen - Hôpital Côte de N-Centre de Recherche Clinique Pédiatriq
state: Calvados
city: Lille
country: France
facility: Hôpital Jeanne de Flandre ( Site 0702)
state: Nord
city: Paris
country: France
facility: Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Robert Debre - Centre Hospitalo Universita
city: Haifa
country: Israel
facility: Rambam Health Care Campus ( Site 0900)
city: Jerusalem
country: Israel
facility: Hadassah Mount Scopus Medical Centre ( Site 0902)
city: Petah-Tikva
country: Israel
facility: Schneider Children's Medical Center ( Site 0903)
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital ( Site 1714)
state: Kanagawa
city: Haebaru
country: Japan
facility: Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701)
state: Okinawa
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital ( Site 1700)
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Aquakids Clinic ( Site 1709)
state: Tokyo
city: Miyazaki
country: Japan
facility: Miyazaki Prefectural Miyazaki Hospital ( Site 1711)
city: Miyazaki
country: Japan
facility: University of Miyazaki Hospital ( Site 1705)
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center ( Site 1713)
city: Saitama
country: Japan
facility: Saitama Prefectural Children's Medical Center ( Site 1702)
city: Wroclaw
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckieg-Klinika Pediatrii i Chorob Infekcyjnyc
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: IN VIVO ( Site 1006)
state: Kujawsko-pomorskie
city: Bydgoszcz
country: Poland
facility: Centrum Medyczne Pratia Bydgoszcz ( Site 1004)
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: Gravita Diagnostyka i Leczenie Niepłodności ( Site 1005)
state: Lodzkie
city: Lomianki
country: Poland
facility: SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007)
state: Mazowieckie
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol ( Site 1104)
state: Barcelona
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Déu ( Site 1113)
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron ( Site 1115)
state: Cataluna
city: Santiago de Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111)
state: La Coruna
city: Madrid
country: Spain
facility: Hospital Universitario La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105)
state: Madrid, Comunidad De
city: Leganés
country: Spain
facility: Hospital Universitario Severo Ochoa ( Site 1114)
state: Madrid
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Unidad Pediátrica de Investigación y Ensayos Clínicos ( Site 11
city: Sevilla
country: Spain
facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112)
city: Solna
country: Sweden
facility: CTC Karolinska ( Site 1201)
state: Stockholms Lan
city: Umeå
country: Sweden
facility: Norrlands universitetssjukhus ( Site 1200)
state: Vasterbottens Lan
city: Mölndal
country: Sweden
facility: CTC GoCo ( Site 1202)
state: Vastra Gotalands Lan
city: Bangkoknoi
country: Thailand
facility: Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 1601)
state: Krung Thep Maha Nakhon
city: Pathumwan
country: Thailand
facility: Chulalongkorn University-Pediatrics ( Site 1602)
state: Krung Thep Maha Nakhon
city: Ratchathewi
country: Thailand
facility: Faculty of Tropical Medicine, Mahidol University - Vaccine Trial Centre ( Site 1604)
state: Krung Thep Maha Nakhon
city: Hat Yai
country: Thailand
facility: Songklanagarind hospital-Department of Pediatrics ( Site 1603)
state: Songkhla
city: Sarçam
country: Turkey
facility: Çukurova Üniversitesi Tıp Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302)
state: Adana
city: Ankara
country: Turkey
facility: Hacettepe Universite Hastaneleri ( Site 1300)
city: Ankara
country: Turkey
facility: Ankara Universitesi Tip Fakultesi Hastanesi ( Site 1304)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301)
city: Istanbul
country: Turkey
facility: Sisli Etfal Training and Research Hospital ( Site 1305)
city: İzmir
country: Turkey
facility: Ege Universitesi Hastanesi ( Site 1306)
city: Kayseri
country: Turkey
facility: Erciyes Universitesi Tıp Fakultesi Hastaneleri-pediatric infection ( Site 1303)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: