CTIS2022-502791-22-01进行中（未招募）1 期
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 18 to 64 years of Age With Increased Risk for Pneumococcal Disease - V116-008
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Has documented result(s) of =1 of the following risk conditions for pneumococcal disease: diabetes mellitus, receiving treatment with =1 approved antidiabetic medication, with all Hemoglobin A1c (HbA1c) measurements =9% within 6 months before first study vaccination; compensated chronic liver disease; diagnosis of chronic obstructive pulmonary disease (COPD) managed per local guidelines; diagnosis of mild or moderate persistent asthma managed per local guidelines; confirmed diagnosis of chronic heart disease managed per local guidelines; confirmed diagnosis of chronic kidney disease (>3 months duration)., Is receiving stable medical management for the risk conditions listed in inclusion criterion 1 for =3 months with no anticipated major change in treatment expected for the duration of the study and with =1 hospitalization directly related to the risk condition., Is an individual of any sex/gender, from 18 years to 64 years of age inclusive, at the time of providing informed consent., Female is not a participant of childbearing potential (POCBP); or if a POCBP Uses an acceptable contraceptive method or is abstinent from penile-vaginal intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis); their medical history, menstrual history, and recent sexual activity has been reviewed by the investigator.
排除标准
- •Has a history of active hepatitis., Had a recent febrile illness or received antibiotic therapy for any acute illness occurring within 72 hours before receipt of any study vaccine., Has a known malignancy that is progressing or has required active treatment <3 years before randomization., Has planned organ transplantation (heart, liver, lung, kidney, or pancreas) or other planned major surgical procedure during the duration of this study., Has expected survival for <1 year., Has received any prior pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study outside the protocol., Has 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 at Visit 2 (Day 1)., Is currently receiving systemic 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 any 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 (including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) live virus vaccines) =30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine =30 days after receipt of any study vaccine., Has received a blood transfusion or blood products, including immunoglobulin =6 months before receipt of any study vaccine or is scheduled to receive a blood transfusion or blood product =30 days after receipt of any study vaccine., Has a history of diabetic ketoacidosis or 2 or more episodes of severe, symptomatic hypoglycemia within 3 months before first study vaccination (Day 1)., Is receiving chronic home oxygen therapy., Has a history of myocardial infarction, acute coronary syndrome, transient ischemic attack, or ischemic or hemorrhagic stroke within 3 months before first study vaccination (Day 1)., Has a history of severe pulmonary hypertension with World Health Organization (WHO) functional class =3 or history of Eisenmenger syndrome., Has a history of autoimmune related chronic kidney disease, chronic kidney failure, a reversible cause of kidney disease, nephrotic syndrome, or any ineligible Kidney Disease: Improving Global Outcomes (KDIGO)-recommended stage of glomerular filtration rate (GFR) and Albuminuria., 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 before first study vaccination (Day 1)., Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid., Has a known or suspected impairment of immunological function including, but not limited to, congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or autoimmune disease., Has a coagulation disorder contraindicating intramuscular (IM) vaccination.
研究者
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