A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (V114-023/PNEU-SICKLE)
2021年5月21日 更新者:Merck Sharp & Dohme LLC
A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Children With Sickle Cell Disease (PNEU-SICKLE)
This study is designed to describe the safety, tolerability, and immunogenicity of V114 in children with sickle cell disease.
研究概览
研究类型
介入性
注册 (实际的)
104
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Atlantico
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Barranquilla、Atlantico、哥伦比亚、080020
- Clinica de la Costa Ltda. ( Site 0300)
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Valle Del Cauca
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Cali、Valle Del Cauca、哥伦比亚、760045
- Centro de Estudios en Infectologia Pediatrica SAS ( Site 0301)
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Santo Domingo、多明尼加共和国、10122
- Clinical Research Republica Dominicana ( Site 0401)
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Santo Domingo、多明尼加共和国、10205
- Caimed Dominicana S.A.S ( Site 0400)
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Santo Domingo
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Distrito Nacional、Santo Domingo、多明尼加共和国、10204
- Fundacion Dominicana de Perinatologia PRO BEBE INC ( Site 0402)
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Panama、巴拿马、0816-00383
- Cevaxin ( Site 0500)
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Panama、巴拿马、0816-00383
- Cevaxin ( Site 0502)
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Salvador、巴西、40420-000
- Hospital Santo Antonio - Obras Sociais Irma Dulce ( Site 0205)
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Sao Paulo、巴西、01221-900
- Santa Casa de Misericordia de Sao Paulo ( Site 0202)
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MG
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Belo Horizonte、MG、巴西、30150-221
- Santa Casa de Misericordia de Belo Horizonte ( Site 0200)
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Athens、希腊、115 27
- Agia Sophia Children s Hospital ( Site 0700)
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Thessaloniki、希腊、546 42
- Hippokration General Hospital of Thessaloniki ( Site 0701)
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Genova、意大利、16132
- Ospedale San Martino ( Site 0800)
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Delaware
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Wilmington、Delaware、美国、19803
- Nemours/Alfred I. duPont Hospital for Children ( Site 0113)
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Georgia
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Atlanta、Georgia、美国、30303
- Children's Healthcare of Atlanta ( Site 0100)
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Michigan
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Detroit、Michigan、美国、48201
- Children's Hospital of Michigan ( Site 0111)
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New Jersey
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Newark、New Jersey、美国、07112
- Newark Beth Israel Medical Center ( Site 0115)
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New York
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Rochester、New York、美国、14642
- University of Rochester Medical Center ( Site 0105)
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Ohio
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Cincinnati、Ohio、美国、45229
- Cincinnati Children's Hospital Medical Center ( Site 0101)
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
5年 至 17年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Documented diagnosis of sickle cell disease in their medical record
Female participants: not pregnant or breastfeeding, and at least 1 of the following conditions apply:
1) not a woman of childbearing potential (WOCBP) as defined in the protocol, or 2) a WOCBP who agrees to follow the contraceptive guidance in the protocol during the treatment period and for at least 6 weeks after the last dose of study vaccine
- Has a legally acceptable representative who understands the study procedures, alternate treatments available, and risks involved with the study and voluntarily agrees to participate by giving written informed consent/assent.
Exclusion Criteria:
- History of Invasive Pneumococcal Disease (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)
- Known hypersensitivity to any component of pneumococcal conjugate vaccine (PCV), or any diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function
- History of congenital or acquired immunodeficiency
- Documented human immunodeficiency virus (HIV) infection
- History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, or type 1 diabetes mellitus)
- Known coagulation disorder contraindicating intramuscular vaccination
- History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 1 (Day 1)
- Received any PCV or pneumococcal polysaccharide vaccine <3 years before Visit 1 (Day 1)
- Five (5) years of age and has received <3 doses of PCV
- Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease. Note: hydroxyurea is permitted
- Received immunoglobulin within 6 months before receipt of study vaccine
- Participated in another clinical study of an investigational product within 2 months before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included
- Recent history (within the last year) of more than 3 inpatient hospitalizations
- At the time of signing informed consent/assent, is a user of recreational or illicit drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence as assessed by the study investigator
- History or current evidence of any condition, therapy, lab abnormality or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant's participation for the full duration of the study in the opinion of the Investigator
- Is or has an immediate family member (eg, spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1.
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V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
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有源比较器:Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1.
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Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Percentage of Participants With a Solicited Injection-site Adverse Event
大体时间:Up to 14 days post-vaccination
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An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Solicited injection-site AEs included injection-site erythema (redness), injection-site induration (hard lump), injection-site pain (tenderness), and injection-site swelling.
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Up to 14 days post-vaccination
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Percentage of Participants With a Solicited Systemic Adverse Event
大体时间:Up to 14 days post-vaccination
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Solicited systemic AEs included arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and urticaria (hives or welts).
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Up to 14 days post-vaccination
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Percentage of Participants With a Vaccine-related Serious Adverse Event
大体时间:Up to 6 months post-vaccination
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A serious adverse event (SAE) is an AE that results in death, is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
SAEs that were reported by the investigator to be at least possibly related to the study vaccination were summarized.
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Up to 6 months post-vaccination
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Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG) at Day 30
大体时间:Day 30
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The GMC of IgG serotype-specific antibodies to the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 were quantitated from participants' sera by a multiplex electrochemiluminescence (ECL) assay.
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Day 30
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) at Day 30
大体时间:Day 30
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Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes (22F and 33F) unique to V114 using the multiplexed opsonophagocytic assay (MOPA).
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Day 30
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Geometric Mean Fold Rise (GMFR) in Serotype-specific IgG From Day 1 (Baseline) to Day 30
大体时间:Day 1 (Baseline) and Day 30
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IgG for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using an electrochemiluminescence assay.
GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
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Day 1 (Baseline) and Day 30
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GMFR in Serotype-specific OPA From Day 1 (Baseline) to Day 30
大体时间:Day 1 (Baseline) and Day 30
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Activity for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™ and 2 serotypes unique to V114 (22F and 33F) was determined using a MOPA.
GMFR is defined as the geometric mean of the ratio of concentration at Day 30 after vaccination divided by concentration at baseline (Day 1, pre-vaccination).
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Day 1 (Baseline) and Day 30
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2019年1月23日
初级完成 (实际的)
2020年6月8日
研究完成 (实际的)
2020年6月8日
研究注册日期
首次提交
2018年11月2日
首先提交符合 QC 标准的
2018年11月2日
首次发布 (实际的)
2018年11月6日
研究记录更新
最后更新发布 (实际的)
2021年6月16日
上次提交的符合 QC 标准的更新
2021年5月21日
最后验证
2021年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- V114-023 (其他标识符:Merck Protocol Number)
- 2018-001152-35 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
V114的临床试验
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Merck Sharp & Dohme LLC完全的
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Merck Sharp & Dohme LLC完全的
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Merck Sharp & Dohme LLC完全的
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Merck Sharp & Dohme LLC完全的
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Merck Sharp & Dohme LLC完全的