Pneumococcal Infection Clinical Trial
Official title:
A Phase 3, Randomized, Double-blind, Active Comparator-controlled Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults
| Verified date | May 2023 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 2664 |
| Est. completion date | May 18, 2023 |
| Est. primary completion date | May 18, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Emeritus Research ( Site 3004) | Botany | New South Wales |
| Australia | Paratus Clinical Research Canberra ( Site 3000) | Bruce | Australian Capital Territory |
| Australia | Emeritus Research ( Site 3003) | Camberwell | Victoria |
| Australia | Paratus Clinical Research Central Coast ( Site 3001) | Kanwal | New South Wales |
| Australia | Westmead Hospital ( Site 3005) | Westmead | New South Wales |
| Belgium | Anima Diepenbeek ( Site 1003) | Diepenbeek | Limburg |
| Belgium | Private Practice - Dr. Martinot Jean-Benoit ( Site 1001) | Erpent | Namur |
| Chile | Universidad San Sebastian - Providencia ( Site 0514) | Providencia | Region M. De Santiago |
| Chile | Centro de Investigacion Clinicadela Universidad Catolica ( Site 0503) | Santiago | Region M. De Santiago |
| Chile | Espacio Eme ( Site 0509) | Santiago | Region M. De Santiago |
| Chile | Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0504) | Temuco | Araucania |
| Germany | Novopraxis Berlin GbR ( Site 1201) | Berlin | |
| Germany | Medizentrum Essen Borbeck ( Site 1200) | Essen | Nordrhein-Westfalen |
| Germany | InfektioResearch ( Site 1203) | Frankfurt | Hessen |
| Germany | Hamburger Institut fuer Therapieforschung GmbH ( Site 1204) | Hamburg | |
| Germany | Universitaetsklinikum Hamburg-Eppendorf-Infektiologie ( Site 1202) | Hamburg | |
| Germany | Universitaetsklinikum Koeln ( Site 1206) | Köln | Nordrhein-Westfalen |
| Korea, Republic of | Korea University Ansan Hospital ( Site 3201) | Ansan-si | Kyonggi-do |
| Korea, Republic of | Kyungpook National University Chilgok Hospital-Division of Infectious Diseases ( Site 3207) | Deagu | Taegu-Kwangyokshi |
| Korea, Republic of | Gachon University Gil Medical Center ( Site 3205) | Namdong-gu | Incheon |
| Korea, Republic of | Ewha Womans University Mokdong Hospital-Infectious Diseases ( Site 3208) | Seoul | |
| Korea, Republic of | Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 3204) | Seoul | |
| Korea, Republic of | Korea University Guro Hospital ( Site 3200) | Seoul | |
| Korea, Republic of | Samsung Medical Center ( Site 3211) | 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 | The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 3202) | Seoul | |
| Korea, Republic of | Ajou University Hospital-Department of Infectious Diseases ( Site 3209) | Suwon-si | Kyonggi-do |
| Korea, Republic of | The Catholic University Of Korea St. Vincent's Hospital-Internal Medicine ( Site 3206) | Suwon-si | Kyonggi-do |
| New Zealand | Southern Clinical Trials Waitemata Ltd ( Site 3105) | Auckland | |
| New Zealand | Southern Clinical Trials Ltd ( Site 3104) | Christchurch | Canterbury |
| New Zealand | Lakeland Clinical Trials ( Site 3102) | Rotorua | Bay Of Plenty |
| New Zealand | P3 Research - Tauranga ( Site 3100) | Tauranga | Bay Of Plenty |
| New Zealand | P3 Research - Wellington ( Site 3101) | Wellington | |
| Puerto Rico | Cooperativa De Facultad Medica Sanacoop-Instituto Sanacoop ( Site 0601) | Bayamon | |
| Puerto Rico | San Juan Bautista School of Medicine - Clinical Research Unit ( Site 0606) | Caguas | |
| Puerto Rico | Clinical Research Investigator Group ( Site 0611) | Canovanas | |
| Puerto Rico | Ponce School Of Medicine Caimed Center ( Site 0602) | Ponce | |
| Puerto Rico | Clinical Research Puerto Rico ( Site 0600) | San Juan | |
| Sweden | ProbarE ( Site 1400) | Lund | Skane Lan |
| Sweden | 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 |
| Taiwan | National Cheng Kung University Hospital ( Site 3301) | Tainan | |
| Taiwan | National Taiwan University Hospital ( Site 3300) | Taipei | |
| Taiwan | Taipei Medical University Hospital ( Site 3302) | Taipei | |
| Taiwan | Chang Gung Medical Foundation-Linkou Branch ( Site 3303) | Taoyuan | |
| Turkey | Sakarya Training and Research Hospital ( Site 2205) | Adapazari | Sakarya |
| Turkey | Ankara City Hospital ( Site 2200) | Ankara | |
| Turkey | Hacettepe Universite Hastaneleri ( Site 2204) | Ankara | |
| Turkey | Acibadem Universitesi Atakent Hastanesi-Infectious Disease ( Site 2201) | Istanbul | |
| United States | JEM Research Institute ( Site 0072) | Atlantis | Florida |
| United States | Lynn Institute of Denver ( Site 0012) | Aurora | Colorado |
| United States | Tekton Research, Inc. ( Site 0053) | Austin | Texas |
| United States | Central Research Associates ( Site 0067) | Birmingham | Alabama |
| United States | Charlottesville Medical Research ( Site 0034) | Charlottesville | Virginia |
| United States | Aventiv Research Inc ( Site 0044) | Columbus | Ohio |
| United States | Alliance for Multispecialty Research, LLC ( Site 0015) | Coral Gables | Florida |
| United States | WR-Global Medical Research, LLC ( Site 0065) | Dallas | Texas |
| United States | Hillcrest Medical Research ( Site 0049) | DeLand | Florida |
| United States | Skyline Medical Center/CCT Research ( Site 0028) | Elkhorn | Nebraska |
| United States | Southland Clinical Research Center-Research ( Site 0054) | Fountain Valley | California |
| United States | Methodist Physicians Clinic/CCT Research ( Site 0058) | Fremont | Nebraska |
| United States | Lenzmeier Family Medicine/CCT Research ( Site 0006) | Glendale | Arizona |
| United States | Velocity Clinical Research, Greenville ( Site 0043) | Greenville | South Carolina |
| United States | Olympus Family Medicine/CCT Research ( Site 0074) | Holladay | Utah |
| United States | Smith Allergy & Asthma Specialists-Corning Center for Clinical Research ( Site 0032) | Horseheads | New York |
| United States | Elixir Research Group - W Houston ( Site 0068) | Houston | Texas |
| United States | Clinical Research Prime ( Site 0010) | Idaho Falls | Idaho |
| United States | East Coast Institute for Research, LLC ( Site 0070) | Jacksonville | Florida |
| United States | Alliance for Multispecialty Research, LLC ( Site 0026) | Kansas City | Missouri |
| United States | Sunwise Clinical Research ( Site 0024) | Lafayette | California |
| United States | East Coast Institute for Research ( Site 0071) | Lake City | Florida |
| United States | Chemidox Clinical Trials ( Site 0048) | Lancaster | California |
| United States | Excel Clinical Research, LLC ( Site 0077) | Las Vegas | Nevada |
| United States | Healor Primary Care / CCT Research ( Site 0056) | Las Vegas | Nevada |
| United States | Santa Rosa Medical Centers of Nevada / CCT Research ( Site 0029) | Las Vegas | Nevada |
| United States | Epic Clinical Research ( Site 0082) | Lewisville | Texas |
| United States | Baptist Health Center For Clinical Research ( Site 0019) | Little Rock | Arkansas |
| United States | DCOL Center for Clinical Research ( Site 0051) | Longview | Texas |
| United States | Advanced Medical Research ( Site 0002) | Maumee | Ohio |
| United States | Solaris Clinical Research ( Site 0008) | Meridian | Idaho |
| United States | Desert Clinical Research/ CCT Research ( Site 0040) | Mesa | Arizona |
| United States | Advanced Medical Research Institute ( Site 0014) | Miami | Florida |
| United States | L&C Professional Medical Research Institute ( Site 0025) | Miami | Florida |
| United States | Trial Management Associates ( Site 0089) | Myrtle Beach | South Carolina |
| United States | Health Research of Hampton Roads, Inc. ( Site 0004) | Newport News | Virginia |
| United States | Meridian Clinical Research, LLC ( Site 0045) | Norfolk | Nebraska |
| United States | Lynn Institute of Norman ( Site 0001) | Norman | Oklahoma |
| United States | South Ogden Family Medicine/ CCT Research ( Site 0022) | Ogden | Utah |
| United States | Lynn Health Science Institute ( Site 0005) | Oklahoma City | Oklahoma |
| United States | Headlands Research Orlando ( Site 0031) | Orlando | Florida |
| United States | Foothills Research Center/ CCT Research ( Site 0021) | Phoenix | Arizona |
| United States | Research Your Health ( Site 0042) | Plano | Texas |
| United States | Summit Headlands ( Site 0047) | Portland | Oregon |
| United States | Paradigm Clinical Research Centers, Inc ( Site 0018) | Redding | California |
| United States | Peninsula Research Associates ( Site 0079) | Rolling Hills Estates | California |
| United States | IMA Clinical Research San Antonio ( Site 0009) | San Antonio | Texas |
| United States | VIP Trials ( Site 0086) | San Antonio | Texas |
| United States | Acclaim Clinical Research ( Site 0083) | San Diego | California |
| United States | Millennium Clinical Trials ( Site 0013) | Simi Valley | California |
| United States | MultiCare Rockwood Cheney Clinic ( Site 0037) | Spokane | Washington |
| United States | Clinical Research Trials of Florida ( Site 0007) | Tampa | Florida |
| United States | Genesis Clinical Research, LLC ( Site 0016) | Tampa | Florida |
| United States | Fiel Family and Sports Medicine, PC/CCT Research ( Site 0003) | Tempe | Arizona |
| United States | Dynamed Clinical Research, LP d/b/a DM Clinical Research-DM Clinical Research ( Site 0036) | Tomball | Texas |
| United States | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0038) | Troy | Michigan |
| United States | Lynn Institute of Tulsa ( Site 0084) | Tulsa | Oklahoma |
| United States | Versailles Family Medicine / CCT Research ( Site 0063) | Versailles | Kentucky |
| United States | Palm Beach Research Center ( Site 0060) | West Palm Beach | Florida |
| United States | Paradigm Clinical Research Centers, Inc ( Site 0027) | Wheat Ridge | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Australia, Belgium, Chile, Germany, Korea, Republic of, New Zealand, Puerto Rico, Sweden, Taiwan, 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 consisted of pain/tenderness, redness/erythema, and swelling. | Up to 5 days postvaccination | |
| 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 consist of headache, muscle aches/myalgia, and tiredness/fatigue. | Up to 5 days postvaccination | |
| Primary | Percentage of participants with vaccine-related serious AE (SAE) | 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. | Up to 194 days postvaccination | |
| Primary | Serotype specific opsonophagocytic (OPA) geometric mean titers (GMTs) in Cohorts 1 and 2 for the 21 serotypes contained in V116 | The serotype specific OPA GMTs for the 21 serotypes contained in V116 will be determined using the multiplex opsonophagocytic assay (MOPA). | Day 30 postvaccination | |
| Primary | Percentage of participants with =4-fold rise from baseline in serotype specific OPAs in Cohort 1 for the 21 serotypes contained in V116 | The percentage of participants with =4-fold rise from baseline in serotype specific OPAs for the 21 serotypes contained in V116 will be determined. | Baseline and Day 30 postvaccination | |
| Secondary | Percentage of participants with =4-fold rise in serotype specific cross-reactive OPA responses in Cohorts 1 and 2 | The percentage of participants with =4-fold rise from baseline in serotype specific cross-reactive OPAs will be determined. | Baseline and Day 30 postvaccination | |
| Secondary | Serotype specific cross-reactive OPA GMTs in Cohorts 1 and 2 | The serotype specific OPA GMTs will be determined using MOPA. | Day 30 postvaccination | |
| Secondary | Serotype specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) in Cohort 1 | The GMCs for serotype specific IgG antibodies will be determined using pneumococcal electrochemiluminescence (PnECL). | Day 30 postvaccination | |
| Secondary | Geometric mean fold rise (GMFR) from baseline in serotype specific OPA GMTs in Cohort 1 | The GMFR from baseline in serotype specific OPA GMTs will be determined using MOPA. | Baseline and Day 30 postvaccination | |
| Secondary | GMFR from baseline in serotype specific IgG GMCs in Cohort 1 | The GMFR in GMCs for serotype specific IgG antibodies will be determined using PnECL. | Baseline and Day 30 postvaccination | |
| Secondary | Percentage of participants with =4-fold rise from baseline in serotype specific IgG GMCs in Cohort 1 | The percentage of participants with =4-fold rise from baseline in GMCs for serotype specific IgG antibodies will be determined using PnECL. | Baseline and Day 30 postvaccination | |
| Secondary | Percentage of participants with =4-fold rise from baseline in serotype specific OPA GMTs in Cohort 1 | The percentage of participants with =4-fold rise from baseline in serotype specific OPAs will be determined. | Baseline and Day 30 postvaccination |
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