Pneumococcal Infection Clinical Trial
— STRIDE-13Official 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
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).
| Status | Recruiting |
| Enrollment | 820 |
| Est. completion date | February 12, 2025 |
| Est. primary completion date | February 12, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 2 Years to 17 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Canadian Center for Vaccinology ( Site 0004) | Halifax | Nova Scotia |
| Canada | Hamilton Medical Research Group ( Site 0008) | Hamilton | Ontario |
| Canada | CHU Sainte-Justine ( Site 0007) | Montréal | Quebec |
| Canada | CHU de Québec-Université Laval ( Site 0006) | Quebec City | Quebec |
| 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 | Hospital Dr. Hernán Henríquez Aravena ( Site 0208) | Temuco | Araucania |
| Colombia | CEIP - Centro de Estudios en Infectología Pediátrica ( Site 0401) | Cali | Valle Del Cauca |
| Colombia | Fundación Valle del Lili ( Site 0404) | Cali | Valle Del Cauca |
| Colombia | Oncomédica S.A.S-Oncomedica S.A ( Site 0402) | Montería | Cordoba |
| Colombia | Clinica Somer ( Site 0405) | Rionegro | Antioquia |
| Finland | FVR, Espoon rokotetutkimusklinikka ( Site 0608) | Espoo | Uusimaa |
| Finland | MeVac - Meilahti Vaccine Research Center ( Site 0609) | Helsinki | Uusimaa |
| Finland | FVR, Kokkolan rokotetutkimusklinikka ( Site 0602) | Kokkola | Mellersta Osterbotten |
| Finland | FVR, Oulun rokotetutkimusklinikka ( Site 0600) | Oulu | Pohjois-Pohjanmaa |
| Finland | FVR, Seinäjoen rokotetutkimusklinikka ( Site 0604) | Seinäjoki | Sodra Osterbotten |
| Finland | FVR, Tampereen rokotetutkimusklinikka ( Site 0603) | Tampere | Pirkanmaa |
| Finland | FVR, Turun rokotetutkimusklinikka ( Site 0606) | Turku | Varsinais-Suomi |
| France | 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 | |
| Israel | Rambam Health Care Campus ( Site 0900) | Haifa | |
| Israel | Schneider Children's Medical Center ( Site 0903) | Petah-Tikva | |
| Japan | Juntendo University Hospital ( Site 1700) | Bunkyo-ku | Tokyo |
| Japan | Aquakids Clinic ( Site 1709) | Edogawa-ku | Tokyo |
| Japan | Okinawa Prefectural Nanbu Medical Center and Children's Medical Center ( Site 1701) | Haebaru | Okinawa |
| 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 | Saiseikai Yokohamashi Tobu Hospital ( Site 1714) | Yokohama | Kanagawa |
| Poland | Centrum Medyczne Pratia Bydgoszcz ( Site 1004) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | IN VIVO ( Site 1006) | Bydgoszcz | Kujawsko-pomorskie |
| Poland | SZPZOZ im. Dzieci Warszawy w Dziekanowie Lesnym ( Site 1007) | Lomianki | Mazowieckie |
| Spain | Hospital Germans Trias i Pujol ( Site 1104) | Badalona | Barcelona |
| Spain | Hospital Universitari Vall d'Hebron ( Site 1115) | Barcelona | |
| Spain | Hospital Sant Joan de Déu ( Site 1113) | Esplugues de Llobregat | Barcelona |
| 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 La Paz-Pediatria y Enfermedades Infecciosas ( Site 1105) | Madrid | Madrid, Comunidad De |
| Spain | CHUS - Hospital Clinico Universitario-Servicio de Pediatría ( Site 1111) | Santiago de Compostela | La Coruna |
| Spain | HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1112) | Sevilla | |
| Sweden | CTC GoCo ( Site 1202) | Mölndal | Vastra Gotalands Lan |
| Sweden | CTC Karolinska ( Site 1201) | Solna | Stockholms Lan |
| Sweden | Norrlands universitetssjukhus ( Site 1200) | Umeå | Vasterbottens Lan |
| Turkey | Ankara Bilkent Sehir Hastanesi-Infectious Disease and Clinical Microbiology ( Site 1301) | Ankara | |
| Turkey | Hacettepe Universite Hastaneleri ( Site 1300) | Ankara | |
| Turkey | Sisli Etfal Training and Research Hospital ( Site 1305) | Istanbul | |
| Turkey | Ege Universitesi Hastanesi ( Site 1306) | Izmir | |
| Turkey | Erciyes Universitesi Tip Fakultesi Hastaneleri-pediatric infection ( Site 1303) | Kayseri | |
| Turkey | Çukurova Üniversitesi Tip Fakültesi Adana Hastanesi-Pediatric Infection ( Site 1302) | Sarçam | Adana |
| United States | Velocity Clinical Research, Albuquerque ( Site 0112) | Albuquerque | New Mexico |
| United States | Velocity Clinical Research, Austin ( Site 0129) | Austin | Texas |
| United States | Central Research Associates ( Site 0145) | Birmingham | Alabama |
| United States | PanAmerican Clinical Research ( Site 0132) | Brownsville | Texas |
| United States | Epic Medical Research - Oklahoma ( Site 0134) | Chickasha | Oklahoma |
| United States | Optumcare Colorado Springs, LLC ( Site 0113) | Colorado Springs | Colorado |
| United States | Epic Medical Research ( Site 0133) | DeSoto | Texas |
| United States | Tribe Clinical Research, LLC-Pediatrics ( Site 0118) | Greenville | South Carolina |
| United States | Velocity Clinical Research, Gulfport ( Site 0115) | Gulfport | Mississippi |
| United States | Clinical Research Prime ( Site 0105) | Idaho Falls | Idaho |
| United States | Alliance for Multispecialty Research, LLC ( Site 0140) | Layton | Utah |
| United States | Midwest Children's Health Research Institute ( Site 0106) | Lincoln | Nebraska |
| United States | Midwest Children's Health Research Institute ( Site 0117) | Lincoln | Nebraska |
| United States | Midwest Children's Health Research Institute-Research ( Site 0102) | Lincoln | Nebraska |
| United States | Midwest Children's Health Research Institute-Research ( Site 0119) | Lincoln | Nebraska |
| United States | Velocity Clinical Research at Primary Pediatrics, Macon ( Site 0128) | Macon | Georgia |
| United States | Madera Family Medical Group ( Site 0120) | Madera | California |
| United States | Epic Medical Research - Mesquite ( Site 0144) | Mesquite | Texas |
| United States | Accel Research Sites Network- Nona Pediatric Center ( Site 0109) | Orlando | Florida |
| United States | Velocity Clinical Research, Phoenix ( Site 0122) | Phoenix | Arizona |
| United States | Clinical Research Prime Rexburg ( Site 0104) | Rexburg | Idaho |
| United States | Tribe Clinical Research - Spartanburg ( Site 0108) | Spartanburg | South Carolina |
| United States | Velocity Clinical Research, Vestal ( Site 0121) | Vestal | New York |
| United States | Velocity Clinical Research, Salt Lake City ( Site 0124) | West Jordan | Utah |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Canada, Chile, Colombia, Finland, France, Israel, Japan, Poland, Spain, Sweden, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of participants with solicited injection-site adverse events (AEs) | 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. | Up to 5 days | |
| Primary | Percentage of participants with solicited systemic AEs | 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. | Up to 5 days | |
| Primary | Percentage of participants with vaccine-related serious adverse events (SAEs) | 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. | Up to approximately 6 months | |
| Primary | Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses | Opsonophagocytic activity (OPA) for the serotypes in V116 will be determined using a multiplexed opsonophagocytic assay (MOPA) | 30 days postvaccination | |
| Secondary | Geometric mean concentrations (GMCs) of serotype-specific Immunoglobulin G (IgG) after vaccination | The GMCs for serotype-specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL) | 30 days postvaccination | |
| Secondary | Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs | The GMFR from baseline in serotype-specific OPA GMTs will be determined using MOPA. | Baseline (Day 1) and Day 30 postvaccination | |
| Secondary | Percentage of participants with =4-fold rise from baseline in serotype-specific OPAs GMTs | The percentage of participants with =4-fold rise from baseline in serotype-specific OPA GMTs will be determined with MOPA. | Baseline (Day 1) and Day 30 postvaccination | |
| Secondary | GMFR from baseline in serotype-specific IgG GMCs | The GMFR from baseline in GMCs for serotype-specific IgG antibodies will be determined using PnECL. | Baseline (Day 1) and Day 30 postvaccination | |
| Secondary | Percentage of participants with =4-fold rise from baseline in serotype-specific IgG GMCs | The percentage of participants with =4-fold rise from baseline in serotype-specific IgG GMCs will be determined using PnECL. | Baseline (Day 1) and Day 30 postvaccination |
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