Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)
- Registration Number
- NCT05425732
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This is a phase 3, randomized, double-blind, active comparator-controlled study of the safety, tolerability, and immunogenicity of V116 compared to PCV20 (pneumococcal 20-valent conjugate vaccine (\[Prevnar 20™ / APEXXNAR™\]) in pneumococcal vaccine-naïve adults. It is hypothesized that V116 is noninferior to PCV20 for the common serotypes and superior to PCV20 for the unique serotypes as assessed by serotype specific opsonophagocytic activity (OPA) 30 days postvaccination. It is also hypothesized that V116 in participants 18 to 49 years of age immunobridges to V116 in participants 50 to 64 years of age as assessed by serotype specific OPA geometric mean titers (GMTs) 30 days postvaccination for all 21 serotypes in V116. Participants ≥50 years of age will be enrolled in Cohort 1, and participants 18 to 49 years of age will be enrolled in Cohort 2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2663
- For females, is not pregnant or breastfeeding and is either not a woman of childbearing potential (WOCBP) or is a WOCBP and uses acceptable contraception/abstinence; and has medical, menstrual, and recent sexual activity history reviewed by the investigator to decrease the chance of an early undetected pregnancy.
- Has a history of invasive pneumococcal disease (IPD) [positive blood culture, positive cerebrospinal fluid culture, or positive culture at another sterile site] or known history of other culture-positive pneumococcal disease within 3 years of Visit 1 (Day 1)
- Has a known hypersensitivity to any component of V116 or PCV20, including diphtheria toxoid
- Has a known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
- Has a coagulation disorder contraindicating IM vaccination
- Had a recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring <72 hours before receipt of study vaccine
- Has a known malignancy that is progressing or has required active treatment <3 years before enrollment
- Received prior administration (prior to age of 5 is acceptable) of any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol
- Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed intervention ≥14 days before receipt of study vaccine
- Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
- Received any nonlive vaccine ≤14 days before receipt of study vaccine or is scheduled to receive any nonlive vaccine ≤30 days after receipt of study vaccine (inactivated influenza and SARS-CoV2 vaccines may be acceptable)
- Received any live virus vaccine ≤30 days before receipt of study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of study vaccine
- Received a blood transfusion or blood products, including immunoglobulin ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product until the Day 30 postvaccination blood draw is complete
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 PCV20 PCV20 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of PCV20 on Day 1. Cohort 1 V116 V116 Pneumococcal vaccine-naïve adult participants (≥50 years of age) receive a single dose of V116 on Day 1. Cohort 2 V116 V116 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of V116 on Day 1. Cohort 2 PCV20 PCV20 Pneumococcal vaccine-naïve adult participants (18 to 49 years of age) receive a single dose of PCV20 on Day 1.
- Primary Outcome Measures
Name Time Method Serotype Specific Opsonophagocytic (OPA) Geometric Mean Titers (GMTs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 Day 30 post-vaccination The serotype specific OPA GMTs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using the multiplex opsonophagocytic assay (MOPA). GMT values were estimated from a constrained longitudinal data analysis; (cLDA) model. Per protocol, within group, confidence intervals (CIs) or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Percentage of Participants With Solicited Injection-site Adverse Events (AEs) Up to 5 days post-vaccination 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 consist of the following: pain/tenderness, redness/erythema, and swelling.
Percentage of Participants With Vaccine-related Serious AE (SAE) Up to 194 days post-vaccination A vaccine-related SAE is any untoward medical consequence that 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 an other important medical event, which is determined by the investigator to be related to the vaccine.
Percentage of Participants With ≥4-fold Change From Baseline in Serotype Specific OPA Responses in Cohort 1 Only for the 11 Unique Pneumococcal Serotypes Contained in V116 Baseline and Day 30 post-vaccination The percentage of participants with ≥4-fold rise from baseline in serotype specific OPAs for the 11 unique pneumococcal serotypes contained in V116. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Serotype Specific OPA GMTs in Participants 18-49 Years and Participants 50-64 Years for the Pneumococcal Serotypes Contained in V116 Day 30 post-vaccination The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA. GMT values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
Percentage of Participants With Solicited Systemic AEs Up to 5 days post-vaccination 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 consist of the following: fatigue (tiredness), headache, myalgia (muscle aches), and pyrexia (maximum temperature ≥ 100.4 °F/38.0 °C)
- Secondary Outcome Measures
Name Time Method Percentage of Participants From Cohort 1 V116 With ≥4-fold Change in OPA Responses for Cross Reactive Pneumococcal Serotypes Baseline and Day 30 post-vaccination The percentage of participants with ≥4-fold rise from baseline was determined for Cohort 1 V116 serotypes 6C and 15B, two serotypes which cross react with PCV20. Point estimate and 95% CI are based on the Clopper-Pearson method. A conclusion of acceptability is based on the lower bound of the 95% CI of the percentages of participants with a ≥4-fold rise from baseline being \> 50 percentage points (one-sided p-value \< 0.025). Per protocol, participants treated with PCV20, and V116 Cohort 2 were not analyzed in this outcome measure.
Geometric Mean Fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 Baseline and Day 30 post-vaccination The GMFR from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Percentage of Participants With ≥4-fold Change From Baseline in IgG Antibody GMCs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 Baseline and Day 30 post-vaccination Percentage of participants with ≥4-fold rise from baseline in serotype specific IgG antibody GMCs for cohort 1 was determined using PnECL. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Serotype Specific OPA GMTs for Cross Reactive Pneumococcal Serotypes in Adults 50 to 64 Years of Age From Cohort 1 and Adults 18 to 49 Years of Age From Cohort 2 Day 30 post-vaccination The serotype specific OPA GMTs for the pneumococcal serotypes in participants 18-49 years and participants 50-64 years treated with V116 only were determined using the MOPA for serotypes 6C and 15B which cross react with PCV20. GMT values were estimated from a LDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. Per protocol, participants treated with PCV20 were not analyzed in this outcome measure.
Percentage of Participants With ≥4-fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 Baseline and Day 30 post-vaccination Percentage of participants with ≥4-fold rise from baseline in OPA GMTs in Cohort 1 was determined using MOPA. The within-group 95% CIs were based on the exact binomial method proposed by Clopper and Pearson. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Serotype Specific Immunoglobulin (IgG) Geometric Mean Concentrations (GMCs) in Cohort 1 Only, for the Pneumococcal Serotypes Contained in V116 and PCV20 Day 30 post-vaccination The serotype specific IgG GMCs for the pneumococcal serotypes in cohort 1 of V116 and PCV20 only were determined using pneumococcal electrochemiluminescence (PnECL). GMC values were estimated from a cLDA model. Per protocol, within group CIs or any other measures of dispersion were not planned or determined. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Geometric Mean Fold Change From Baseline in OPA GMTs in Cohort 1 for the Pneumococcal Serotypes Contained in V116 and PCV20 Baseline and Day 30 post-vaccination The geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs for cohort 1 was determined using MOPA. The within-group 95% CIs were obtained by exponentiating the CIs of the mean of the natural log values based on the t-distribution. The 10 common pneumococcal serotypes in both V116 and PCV20 were as follows: 3, 6A, 7F, 8, 10A, 11A, 12F, 19A, 22F, and 33F. The 11 unique pneumococcal serotypes in V116 were as follows: 9N, 15A, 15C, 16F, 17F, 20A, 23A, 23B, 24F, 31, and 35B. Per protocol, Cohort 2 were not analyzed in this outcome measure.
Trial Locations
- Locations (112)
Baptist Health Center For Clinical Research ( Site 0019)
🇺🇸Little Rock, Arkansas, United States
Millennium Clinical Trials ( Site 0013)
🇺🇸Simi Valley, California, United States
Alliance for Multispecialty Research, LLC ( Site 0015)
🇺🇸Coral Gables, Florida, United States
Paradigm Clinical Research Centers, Inc ( Site 0027)
🇺🇸Wheat Ridge, Colorado, United States
Hillcrest Medical Research ( Site 0049)
🇺🇸DeLand, Florida, United States
Clinical Research Prime ( Site 0010)
🇺🇸Idaho Falls, Idaho, United States
Versailles Family Medicine / CCT Research ( Site 0063)
🇺🇸Versailles, Kentucky, United States
Meridian Clinical Research, LLC ( Site 0045)
🇺🇸Norfolk, Nebraska, United States
Aventiv Research Inc ( Site 0044)
🇺🇸Columbus, Ohio, United States
Trial Management Associates ( Site 0089)
🇺🇸Myrtle Beach, South Carolina, United States
Research Your Health ( Site 0042)
🇺🇸Plano, Texas, United States
Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036)
🇺🇸Tomball, Texas, United States
MultiCare Rockwood Cheney Clinic ( Site 0037)
🇺🇸Spokane, Washington, United States
Universitaetsklinikum Koeln ( Site 1206)
🇩🇪Köln, Nordrhein-Westfalen, Germany
Hamburger Institut fuer Therapieforschung GmbH ( Site 1204)
🇩🇪Hamburg, Germany
Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3207)
🇰🇷Deagu, Taegu-Kwangyokshi, Korea, Republic of
Lakeland Clinical Trials ( Site 3102)
🇳🇿Rotorua, Bay Of Plenty, New Zealand
P3 Research - Tauranga ( Site 3100)
🇳🇿Tauranga, Bay Of Plenty, New Zealand
Ponce School Of Medicine Caimed Center ( Site 0602)
🇵🇷Ponce, Puerto Rico
Advanced Medical Research ( Site 0002)
🇺🇸Maumee, Ohio, United States
WR-Global Medical Research, LLC ( Site 0065)
🇺🇸Dallas, Texas, United States
Elixir Research Group - W Houston ( Site 0068)
🇺🇸Houston, Texas, United States
L&C Professional Medical Research Institute ( Site 0025)
🇺🇸Miami, Florida, United States
Healor Primary Care / CCT Research ( Site 0056)
🇺🇸Las Vegas, Nevada, United States
Private Practice - Dr. Martinot Jean-Benoit ( Site 1001)
🇧🇪Erpent, Namur, Belgium
Central Research Associates ( Site 0067)
🇺🇸Birmingham, Alabama, United States
IMA Clinical Research San Antonio ( Site 0009)
🇺🇸San Antonio, Texas, United States
Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202)
🇩🇪Hamburg, Germany
Foothills Research Center/ CCT Research ( Site 0021)
🇺🇸Phoenix, Arizona, United States
Sunwise Clinical Research ( Site 0024)
🇺🇸Lafayette, California, United States
Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003)
🇺🇸Tempe, Arizona, United States
Chemidox Clinical Trials ( Site 0048)
🇺🇸Lancaster, California, United States
East Coast Institute for Research, LLC ( Site 0070)
🇺🇸Jacksonville, Florida, United States
Genesis Clinical Research, LLC ( Site 0016)
🇺🇸Tampa, Florida, United States
Palm Beach Research Center ( Site 0060)
🇺🇸West Palm Beach, Florida, United States
Solaris Clinical Research ( Site 0008)
🇺🇸Meridian, Idaho, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038)
🇺🇸Troy, Michigan, United States
Skyline Medical Center/CCT Research ( Site 0028)
🇺🇸Elkhorn, Nebraska, United States
Methodist Physicians Clinic/CCT Research ( Site 0058)
🇺🇸Fremont, Nebraska, United States
Excel Clinical Research, LLC ( Site 0077)
🇺🇸Las Vegas, Nevada, United States
Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032)
🇺🇸Horseheads, New York, United States
Lynn Institute of Norman ( Site 0001)
🇺🇸Norman, Oklahoma, United States
Lynn Health Science Institute ( Site 0005)
🇺🇸Oklahoma City, Oklahoma, United States
Velocity Clinical Research, Greenville ( Site 0043)
🇺🇸Greenville, South Carolina, United States
Lynn Institute of Tulsa ( Site 0084)
🇺🇸Tulsa, Oklahoma, United States
Epic Clinical Research ( Site 0082)
🇺🇸Lewisville, Texas, United States
South Ogden Family Medicine/ CCT Research ( Site 0022)
🇺🇸Ogden, Utah, United States
Olympus Family Medicine/CCT Research ( Site 0074)
🇺🇸Holladay, Utah, United States
VIP Trials ( Site 0086)
🇺🇸San Antonio, Texas, United States
Health Research of Hampton Roads, Inc. ( Site 0004)
🇺🇸Newport News, Virginia, United States
Paratus Clinical Research Canberra ( Site 3000)
🇦🇺Bruce, Australian Capital Territory, Australia
Emeritus Research ( Site 3004)
🇦🇺Botany, New South Wales, Australia
Paratus Clinical Research Central Coast ( Site 3001)
🇦🇺Kanwal, New South Wales, Australia
Westmead Hospital ( Site 3005)
🇦🇺Westmead, New South Wales, Australia
Anima Diepenbeek ( Site 1003)
🇧🇪Diepenbeek, Limburg, Belgium
Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503)
🇨🇱Santiago, Region M. De Santiago, Chile
Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0504)
🇨🇱Temuco, Araucania, Chile
Espacio Eme ( Site 0509)
🇨🇱Santiago, Region M. De Santiago, Chile
Universidad San Sebastian - Providencia ( Site 0514)
🇨🇱Providencia, Region M. De Santiago, Chile
InfektioResearch ( Site 1203)
🇩🇪Frankfurt, Hessen, Germany
Medizentrum Essen Borbeck ( Site 1200)
🇩🇪Essen, Nordrhein-Westfalen, Germany
Novopraxis Berlin GbR ( Site 1201)
🇩🇪Berlin, Germany
Ajou University Hospital-Department of Infectious Diseases ( Site 3209)
🇰🇷Suwon-si, Kyonggi-do, Korea, Republic of
Korea University Ansan Hospital ( Site 3201)
🇰🇷Ansan-si, Kyonggi-do, Korea, Republic of
Gachon University Gil Medical Center ( Site 3205)
🇰🇷Namdong-gu, Incheon, Korea, Republic of
The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 3206)
🇰🇷Suwon-si, Kyonggi-do, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3202)
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System-Division of Infectious Diseases ( Site 3210)
🇰🇷Seoul, Korea, Republic of
The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3203)
🇰🇷Seoul, Korea, Republic of
Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3204)
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center ( Site 3211)
🇰🇷Seoul, Korea, Republic of
Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 3208)
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital ( Site 3200)
🇰🇷Seoul, Korea, Republic of
Southern Clinical Trials Ltd ( Site 3104)
🇳🇿Christchurch, Canterbury, New Zealand
Southern Clinical Trials Waitemata Ltd ( Site 3105)
🇳🇿Auckland, New Zealand
P3 Research - Wellington ( Site 3101)
🇳🇿Wellington, New Zealand
San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606)
🇵🇷Caguas, Puerto Rico
Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601)
🇵🇷Bayamon, Puerto Rico
ProbarE ( Site 1400)
🇸🇪Lund, Skane Lan, Sweden
Clinical Research Investigator Group ( Site 0611)
🇵🇷Canovanas, Puerto Rico
CTC Karolinska ( Site 1405)
🇸🇪Solna, Stockholms Lan, Sweden
ProbarE i Stockholm AB ( Site 1401)
🇸🇪Stockholm, Stockholms Lan, Sweden
Studieenheten Akademiskt Specialistcentrum ( Site 1403)
🇸🇪Stockholm, Stockholms Lan, Sweden
CTC MTC ( Site 1404)
🇸🇪Uppsala, Uppsala Lan, Sweden
Ankara City Hospital ( Site 2200)
🇹🇷Ankara, Turkey
Sakarya Training and Research Hospital ( Site 2205)
🇹🇷Adapazarı, Sakarya, Turkey
Hacettepe Universite Hastaneleri ( Site 2204)
🇹🇷Ankara, Turkey
Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201)
🇹🇷Istanbul, Turkey
Lynn Institute of Denver ( Site 0012)
🇺🇸Aurora, Colorado, United States
Clinical Research Trials of Florida ( Site 0007)
🇺🇸Tampa, Florida, United States
Summit Headlands ( Site 0047)
🇺🇸Portland, Oregon, United States
Southland Clinical Research Center-Research ( Site 0054)
🇺🇸Fountain Valley, California, United States
Advanced Medical Research Institute ( Site 0014)
🇺🇸Miami, Florida, United States
Paradigm Clinical Research Centers, Inc ( Site 0018)
🇺🇸Redding, California, United States
JEM Research Institute ( Site 0072)
🇺🇸Atlantis, Florida, United States
Tekton Research, Inc. ( Site 0053)
🇺🇸Austin, Texas, United States
DCOL Center for Clinical Research ( Site 0051)
🇺🇸Longview, Texas, United States
Charlottesville Medical Research ( Site 0034)
🇺🇸Charlottesville, Virginia, United States
Peninsula Research Associates ( Site 0079)
🇺🇸Rolling Hills Estates, California, United States
Taipei Medical University Hospital ( Site 3302)
🇨🇳Taipei, Taiwan
Acclaim Clinical Research ( Site 0083)
🇺🇸San Diego, California, United States
Lenzmeier Family Medicine/CCT Research ( Site 0006)
🇺🇸Glendale, Arizona, United States
National Cheng Kung University Hospital ( Site 3301)
🇨🇳Tainan, Taiwan
Desert Clinical Research/ CCT Research ( Site 0040)
🇺🇸Mesa, Arizona, United States
Emeritus Research ( Site 3003)
🇦🇺Camberwell, Victoria, Australia
Clinical Research Puerto Rico ( Site 0600)
🇵🇷San Juan, Puerto Rico
Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029)
🇺🇸Las Vegas, Nevada, United States
National Taiwan University Hospital ( Site 3300)
🇨🇳Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 3303)
🇨🇳Taoyuan, Taiwan
Headlands Research Orlando ( Site 0031)
🇺🇸Orlando, Florida, United States
Alliance for Multispecialty Research, LLC ( Site 0026)
🇺🇸Kansas City, Missouri, United States
East Coast Institute for Research ( Site 0071)
🇺🇸Lake City, Florida, United States
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