2022-502791-22-01已完成3 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
Merck Sharp & Dohme LLC, Merck Sharp & Dohme LLC7 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年4月11日最近更新:
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 7
- 主要终点
- Percentage of participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 postvaccination
研究概览
简要总结
- To evaluate the safety and tolerability of V116 as assessed by the proportion of participants with adverse events (AEs).
- To evaluate the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) postvaccination with V116 (30 days postvaccination [Day 30]) and PCV15 + PPSV23 (30 days postvaccination with the final dose in the regimen [Week 12]) within each vaccination group separately.
研究设计
- 分配方式
- Randomized
- 主要目的
- Overall trial
- 盲法
- Double (Monitor, Analyst, Subject, Investigator, Carer)
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 接受健康志愿者
- 是
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.
结局指标
主要结局
Percentage of participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 postvaccination
Percentage of participants with solicited injection-site adverse events (AEs) from Day 1 through Day 5 postvaccination
Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination
Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination
Percentage of participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study
Percentage of participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in the study
Serotype-specific OPA GMTs postvaccination with V116 (30 days postvaccination [Day 30]) or PCV15 + PPSV23 (30 days postvaccination with the final dose in the regimen [Week 12])
Serotype-specific OPA GMTs postvaccination with V116 (30 days postvaccination [Day 30]) or PCV15 + PPSV23 (30 days postvaccination with the final dose in the regimen [Week 12])
次要结局
- Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) postvaccination with V116 (Day 30) and PCV15 + PPSV23 (Week 12)
- Serotype-specific geometric mean fold rises (GMFRs) from baseline (Day 1) to postvaccination with V116 (Day 30) and from baseline (Day 1) to postvaccination with PCV15 + PPSV2 (Week 12) for OPA responses
- Serotype-specific GMFRs from baseline (Day 1) to postvaccination with V116 (Day 30) and from baseline (Day 1) to postvaccination with PCV15 + PPSV23 (Week 12) for IgG responses
- Serotype-specific proportion of participants with a ≥4-fold rise from baseline (Day 1) to postvaccination with V116 (Day 30) and from baseline (Day 1) to postvaccination with PCV15 + PPSV2 (Week 12) for OPA responses
- Serotype-specific proportion of participants with a ≥4-fold rise from baseline (Day 1) to postvaccination with V116 (Day 30) and from baseline (Day 1) to postvaccination with PCV15 + PPSV2 (Week 12) for IgG responses
研究者
Jayani Pathirana, Clinical Director
Scientific
Merck Sharp & Dohme LLC
研究点 (7)
Loading locations...
相似试验
已完成
3 期
Safety and Immunogenicity of V116 in Children and Adolescents With Increased Risk for Pneumococcal Disease2023-506236-32-00Merck Sharp & Dohme LLC215
已完成
3 期
A Clinical Study of the V116 Vaccine for Children and Teenagers (V116-013)Pneumococcal InfectionNCT06177912Merck Sharp & Dohme LLC882
已完成
3 期
Safety and Immunogenicity of V114 in Healthy Adults (V114-019/PNEU-AGE)Pneumococcal InfectionsNCT03950622Merck Sharp & Dohme LLC1,205
已完成
3 期
Lot-to-Lot Consistency of V114 in Healthy Adults (V114-020)Pneumococcal InfectionsPneumonia, PneumococcalNCT03950856Merck Sharp & Dohme LLC2,340
已完成
3 期
Safety and Immunogenicity of Catch-up Vaccination Regimens of V114 (V114-024)Pneumococcal InfectionsNCT03885934Merck Sharp & Dohme LLC606