Pneumonia, Pneumococcal Clinical Trial
Official title:
A Phase 3 Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-Experienced Adults 50 Years of Age or Older
| Verified date | April 2024 |
| Source | Merck Sharp & Dohme LLC |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.
| Status | Completed |
| Enrollment | 717 |
| Est. completion date | May 16, 2023 |
| Est. primary completion date | May 16, 2023 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | The main inclusion and exclusion criteria include but are not limited to the following: Inclusion Criteria: - Has received pneumococcal vaccine >= 1 year before enrollment (PCV13, PCV15, PCV20, PPSV23, PCV13+PPSV23, PPSV23+PCV13, or PCV15+PPSV23). Exclusion Criteria: - Has a history of invasive pneumococcal disease (IPD). - Has a known hypersensitivity to any component of V116, PCV15, PCV20, or PPSV23, 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 intramuscular vaccination. - Has a known malignancy that is progressing or has required active treatment. - Has received PPSV23 followed by either PCV15 or PCV20. - Received systemic corticosteroids (prednisone equivalent of =20 mg/day). - 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. - Has received any non-live vaccine =14 days before receipt of study vaccine or is scheduled to receive any non-live vaccine =30 days after receipt of any study vaccine. - Has 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. - Has 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 post-vaccination blood draw is complete. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Hamilton Medical Research Group ( Site 0114) | Hamilton | Ontario |
| Canada | Milestone Research Inc. ( Site 0104) | London | Ontario |
| Canada | Manna Research Mirabel ( Site 0109) | Mirabel | Quebec |
| Canada | CHU de Québec-Université Laval-Équipe de recherche en vaccination ( Site 0120) | Quebec City | Quebec |
| Canada | Diex Recherche Sherbrooke Inc. ( Site 0101) | Sherbrooke | Quebec |
| France | CHRU de Brest ( Site 0200) | Brest | Finistere |
| France | Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0203) | Paris | |
| France | CHU Bordeaux Haut-Leveque ( Site 0202) | Pessac | Aquitaine |
| France | centre hospitalier lyon sud ( Site 0204) | Pierre-Bénite | Rhone |
| Israel | Rambam Health Care Campus ( Site 0303) | Haifa | |
| Israel | Maccabi Health Services - Holon ( Site 0305) | Holon | |
| Israel | Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300) | Jerusalem | |
| Israel | Maccabi Healthcare Services ( Site 0306) | Jerusalem | |
| Israel | Meir Medical Center ( Site 0301) | Kfar Saba | |
| Israel | Sheba Medical Center-Early Phase Clinical Trials Unit ( Site 0304) | Ramat Gan | |
| Israel | Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 0302) | Sakhnin | |
| Italy | Azienda Ospedaliero Universitaria Policlinico Riuniti di Foggia ( Site 0405) | Foggia | |
| Italy | Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico ( Site 0400) | Milano | Lombardia |
| Italy | Ospedale San Raffaele ( Site 0403) | Milano | Lombardia |
| Italy | A.O.U. Policlinico Paolo Giaccone ( Site 0402) | Palermo | Sicilia |
| Japan | PS Clinic ( Site 0700) | Fukuoka | |
| Japan | Nishikumamoto Hospital ( Site 0701) | Kumamoto | |
| Korea, Republic of | Korea University Ansan Hospital ( Site 0751) | Ansan-si | Kyonggi-do |
| Korea, Republic of | Gachon University Gil Medical Center ( Site 0755) | Namdong-gu | Incheon |
| Korea, Republic of | Hallym University Kangnam Sacred Heart Hospital-Internal Medicine ( Site 0754) | Seoul | |
| Korea, Republic of | Korea University Guro Hospital ( Site 0750) | Seoul | |
| Korea, Republic of | The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 0753) | Seoul | |
| Korea, Republic of | The Catholic University of Korea, Eunpyeong St. Mary's Hospital ( Site 0752) | Seoul | |
| Spain | HOSPITAL CLÍNIC DE BARCELONA-Medicina Preventiva i Epidemiologia ( Site 0503) | Barcelona | Cataluna |
| Spain | Hospital Internacional Xanit ( Site 0520) | Benalmadena | Malaga |
| Spain | EBA CENTELLES ( Site 0500) | Centelles | Cataluna |
| Spain | Hospital Universitari de Bellvitge ( Site 0505) | L'Hospitalet de Llobregat | Cataluna |
| Spain | Hospital La Princesa ( Site 0515) | Madrid | |
| Spain | HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-Respiratory ( Site 0508) | Pozuelo de Alarcon | Madrid |
| Taiwan | National Cheng Kung University Hospital ( Site 0801) | Tainan | |
| Taiwan | National Taiwan University Hospital ( Site 0800) | Taipei | |
| United States | Central Research Associates ( Site 0024) | Birmingham | Alabama |
| United States | Alliance for Multispecialty Research, LLC ( Site 0020) | Coral Gables | Florida |
| United States | Centennial Medical Group ( Site 0002) | Elkridge | Maryland |
| United States | Southland Clinical Research Center ( Site 0026) | Fountain Valley | California |
| United States | University of Texas Medical Branch-Sealy Institute for Vaccine Sciences Clinical Trials Program ( Si | Galveston | Texas |
| United States | Lenzmeier Family Medicine/CCT Research ( Site 0008) | Glendale | Arizona |
| United States | Indago Research & Health Center, Inc ( Site 0005) | Hialeah | Florida |
| United States | Advanced Medical Research ( Site 0001) | Maumee | Ohio |
| United States | Solaris Clinical Research ( Site 0025) | Meridian | Idaho |
| United States | Advanced Medical Research Institute ( Site 0018) | Miami | Florida |
| United States | Health Research of Hampton Roads, Inc. ( Site 0003) | Newport News | Virginia |
| United States | Meridian Clinical Research, LLC ( Site 0009) | Norfolk | Nebraska |
| United States | Fiel Family and Sports Medicine, PC/CCT Research ( Site 0006) | Tempe | Arizona |
| United States | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0016) | Troy | Michigan |
| United States | Diablo Clinical Research, Inc. ( Site 0019) | Walnut Creek | California |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Canada, France, Israel, Italy, Japan, Korea, Republic of, Spain, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Solicited Injection-site Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any injection with either V116, PCV15, or PPSV23 the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were erythema, pain, and swelling. | Up to 5 days post-vaccination | |
| Primary | Percentage of Participants With Solicited Systemic AEs | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following any of the injections with either V116, PCV15, or PPSV23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, headache, myalgia, and pyrexia. | Up to 5 days post-vaccination | |
| Primary | Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) | A serious adverse event (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. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination are presented. | Up to ~180 days | |
| Primary | Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) | OPA for the serotypes contained in V116 were determined using a multiplex opsonophagocytic assay (MOPA). GMT is defined as geometric mean titer (1/dil). Serotype-specific OPA GMTs with 95% confidence intervals are presented. | 30 Days post-vaccination | |
| Secondary | Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) | The geometric mean concentration (GMC) of serotype-specific immunoglobulin G (IgG) for the serotypes contained in V116 was determined using a pneumococcal electrochemiluminescence (PnECL) assay. Serotype-specific pneumococcal IgG GMCs with 95% confidence intervals are presented. | 30 Days post-vaccination | |
| Secondary | Geometric Mean Fold Rise in Serotype-specific Opsonophagocytic Activity (OPA) | Activity for the serotypes contained in V116 was determined using a multiplex opsonophagocytic assay (MOPA). Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs in OPA responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented. | Day 1 (Baseline) and 30 days post-vaccination | |
| Secondary | Percentage of Participants Who Achieve a =4-fold Increase in Serotype-specific OPA Responses | Activity for the serotypes contained in V116 was determined using a MOPA. The percentage of participants with a =4-fold rise from baseline to at 30 days post-vaccination for OPA responses with 95% confidence intervals are presented. | Day 1 (Baseline) and 30 days post-vaccination | |
| Secondary | Geometric Mean Fold Rise of Serotype-specific IgG | Activity for the serotypes contained in V116 was determined using a PnECL assay. Geometric mean fold rise (GMFR) is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline. The GMFRs IgG responses from baseline to 30 days post-vaccination with 95% confidence intervals are presented. | Day 1 (Baseline) and 30 days post-vaccination | |
| Secondary | Percentage of Participants Who Achieve a =4-fold Increase in Serotype-specific IgG Response | Activity for the serotypes contained in V116 was determined using a PnECL assay. The percentage of participants with a =4-fold rise from baseline to at 30 days post-vaccination for IgG responses with 95% confidence intervals are presented. | Day 1 (Baseline) and 30 days post-vaccination |
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