A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK)
赞助:
Merck Sharp & Dohme Corp.
合作者:
信息的提供 (责任方):
，
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 28, 2018 | ||
| 首次发布日期e ICMJE | October 2, 2018 | ||
| 最后更新发布日期 | October 2, 2018 | ||
| 预计研究开始日期 ICMJE | December 13, 2018 | ||
| 预计主要完成日期 | January 8, 2021 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Percentage of Participants with a Solicited Injection-site Adverse Event[ Time Frame: Up to Day 14 after each study vaccination ] An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness/erythema, swelling, pain/tenderness, and hard lump/induration. Percentage of Participants with a Solicited Systemic Adverse Event[ Time Frame: Up to Day 14 after each study vaccination ] An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be irritability, drowsiness/somnolence, appetite lost/decreased appetite, and hives or welts/urticaria. Percentage of Participants with a Vaccine-related Serious Adverse Event[ Time Frame: Up to 6 months after Dose 4 (Month 19) ] 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. Relatedness of an SAE to the study vaccine will be determined by the investigator. |
||
| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
|
||
| 描述性信息 | |||
| 简略标题 ICMJE | A Study to Evaluate the Safety and Tolerability of V114 and Prevnar 13™ in Healthy Infants (V114-031/PNEU-LINK) | ||
| 正式标题 ICMJE | A Phase 3, Multicenter, Randomized, Double-blind, Active Comparator Controlled Study to Evaluate the Safety and Tolerability of V114 in Healthy Infants (PNEU -LINK) | ||
| 简要概况 | This study is designed to evaluate the safety and tolerability of V114 and Prevnar 13™ in healthy infants. This study will include both full-term infants (≥37 weeks gestational age) and premature infants (<37 weeks gestational age). Premature infants will be included in a Premature Infant Immunogenicity Substudy, which will assess immunogenicity and safety following administration of V114 or Prevnar 13™. |
||
| 详细说明 | |||
| 研究类型 ICMJE | Interventional | ||
| 研究阶段 | Phase 3 | ||
| 研究设计 ICMJE | 分配: Randomized 干预模型: Parallel Assignment 干预模型描述: 盲法: Interventional 盲法描述: 主要目的: Prevention |
||
| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
|
||
| 研究工具 |
|
||
| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
2400 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | January 8, 2021 | ||
| 预计主要完成日期 | January 8, 2021 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Healthy (based on a review of medical history and physical examination) based on the clinical judgment of the investigator - Male or female approximately 2 months of age, from 42 days to 90 days inclusive, at the time of obtaining the informed consent - Have 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. Exclusion Criteria: - History of Invasive Pneumococcal Disease (IPD) (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease - Known hypersensitivity to any component of the pneumococcal conjugate vaccine (PCV) or any diphtheria toxoid containing vaccine - Known or suspected impairment of immunological function - History of congenital or acquired immunodeficiency - Has or his/her mother has a documented human immunodeficiency virus (HIV) infection - Known or history of functional or anatomic asplenia - Failure to thrive based on the clinical judgment of the investigator - Known coagulation disorder contraindicating intramuscular vaccination - History of autoimmune disease (including but not limited to systemic lupus erythematosus, antiphospholipid syndrome, Behcet's disease, autoimmune thyroid disease, polymyositis and dermatomyositis, scleroderma, type 1 diabetes mellitus, or other autoimmune disorders) - Known neurologic or cognitive behavioral disorder, including encephalitis/myelitis, acute disseminating encephalomyelitis, pervasive development disorder, and related disorders - Received a dose of any pneumococcal vaccine prior to study entry - Received a blood transfusion or blood products, including immunoglobulins, before receipt of first dose of study vaccine - Participated in another clinical study of an investigational product before the beginning or anytime during the duration of the current clinical study. Participants enrolled in observational studies may be included. - Has any other reason that, in the opinion of the investigator, may interfere with the evaluation required by the study - Has an immediate family member who is investigational site or Sponsor staff directly involved with this study. | ||
| 性别 |
|
||
| 年龄 | 最小年龄：42 Days ，最大年龄：90 Days | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | Yes | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: Yes 研究涉及美国FDA监管的设备产品: No |
||
| IPD 共享声明 |
|
||
| 责任方 | ， | ||
| 研究赞助商 ICMJE | Merck Sharp & Dohme Corp. | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
|
||
| PRS 账户 | |||
| 验证日期 | September 2018 | ||
|
ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
|||
请使用微信扫码报名
京公网安备 11010102003638号