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成人（45 至 60 岁和 >60 至 79 岁）登革热四价疫苗 (TDV) 的研究

2026年9月21日 更新者：Takeda

一项 3 期、随机、双盲、安慰剂对照（老年人，年龄 >60 至 79 岁）和开放标签（成人，年龄 45 至 60 岁）多中心试验，研究登革热四价的安全性和免疫原性登革热流行地区有或没有合并症的成人和老年人皮下注射疫苗 (TDV)

Dengue fever is caused by an infection with the dengue virus. Vaccination with Dengue Tetravalent Vaccine (TDV) can help prevent dengue fever. Researchers have seen that dengue fever now also happens more often in elderly persons. The main aim of this study is to learn more about the side effects of TDV in adult (45 - 60 years) and elderly (60 - 79 years) persons and about TDV's ability to create an immune response in adult and elderly persons. Another aim is to learn about the side effects of TDV in adult and elderly persons in endemic countries who have one or more additional medical conditions (called comorbidities) such as diabetes mellitus, hypertension or a chronic kidney condition.

In this study, participants will receive 2 vaccinations with TDV (the second 3 months after the first).

During the study, participants will visit their study clinic 5 times.

研究概览

地位

主动，不招人

条件

干预/治疗

研究类型

介入性

注册 (实际的)

800

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

  • 巴西
    • Estado de Bahia
      • Salvador、Estado de Bahia、巴西、40444-130
        • Associacao Obras Sociais Irma Dulce Hospital Santo Antonio
    • São Paulo
      • São José do Rio Preto、São Paulo、巴西、15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
  • 新加坡
      • Singapore、新加坡、169608
        • Singapore General Hospital (SGH)
      • Singapore、新加坡、308433
        • Tan Tock Seng Hospital
  • 泰国
    • Bangkok
      • Ratchathewi、Bangkok、泰国、10400
        • Ramathibodi Hospital
    • Krung Thep Maha Nakhon-Bangkok
      • Ratchathewi、Krung Thep Maha Nakhon-Bangkok、泰国、10400
        • Hospital for Tropical Diseases
  • 阿根廷
      • Buenos Aires、阿根廷、C1427CEA
        • Fundacion Huesped - PPDS

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

45年 至 79年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Participant is aged 45 to 79 years at the time of entry into the trial.
  2. Participant is male or female.
  3. Participant is in good health or has a medical diagnosis of one or more of diabetes mellitus, hypertension, or chronic kidney disease (that is, comorbidities) and are medically stable in the opinion of the investigator at the time of entry into the trial, as determined by medical history and targeted physical examination. Medically stable is defined as no change in diagnoses or chronic medications (dose or class) for medical reasons in the 3 months prior to participating in the trial.
  4. Participant has signed and dated a written informed consent form and any required privacy authorization prior to the initiation of any trial procedure, and after the nature of the trial has been explained according to local regulatory requirements.
  5. Participant can comply with trial procedures and is available for the duration of follow-up.

Exclusion Criteria:

  1. Participant has contraindication(s), warning(s), and/or precaution(s) applicable to vaccination with TDV as specified in the Investigator's Brochure and/or approved product label (as applicable) in the participating country.

  2. Participant has a known hypersensitivity or allergy to any of the TDV or placebo components (including excipients).

  3. Participant has behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, could interfere with the participant's ability to take part in the trial.

  4. Participant has a history of progressive or severe neurologic disorder, seizure disorder or neuro-inflammatory disease (example, Guillain-Barré syndrome).

  5. Participant has an illness, or history of any illness that, in the opinion of the investigator, might interfere with the results of the trial or pose additional risk to the participant due to involvement in this trial.

  6. Participant has a known or suspected altered immunocompetence, including:

    1. Chronic administration of oral and/or parenteral steroids at doses considered sufficiently immunosuppressive (example, greater than or equal to [>=] 2 milligram per kilogram [mg/kg] body weight prednisone [or equivalent] for >=14 consecutive days, or >=20 milligram per day [mg/day] prednisone [or equivalent] administered for >=14 consecutive days) within 60 days prior to Day 1 (month [M0]) (note: use of corticosteroids by inhaled, intranasal, intra-articular, bursal, tendon injection, or topical routes is allowed).
    2. Receipt of immunoglobulins and/or any blood products within the 3 months prior to Day 1 (M0) or planned administration during the trial.
    3. Receipt of immunostimulants within 60 days prior to Day 1 (M0).
    4. Immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within 6 months prior to Day 1 (M0).
    5. Human Immunodeficiency Virus (HIV) infection or HIV-related disease.
    6. Hepatitis B virus infection.
    7. Hepatitis C virus infection.
    8. Genetic immunodeficiency.

  7. Participant has known or suspected abnormalities of splenic or thymic function.

  8. Participant has a known bleeding diathesis, or any condition/medication that may be associated with a prolonged bleeding time.

  9. Participant has a serious chronic or progressive disease deemed to be preclusive to trial entry, that is, not medically stable according to the judgment of the investigator.

  10. Participant has previously received a vaccination against dengue virus (investigational or licensed).

  11. Participant had a clinically significant active infection (as assessed by the investigator) or body temperature >38.0 degree Celsius (>100.4 degree Fahrenheit) within 3 days of intended TDV or placebo administration.

  12. Participant has used antipyretics and/or analgesic medications within 24 hours prior to vaccination. The reason for their use (prophylaxis vs treatment) must be documented. Trial entry must be delayed to allow for a full 24 hours to have passed since the last use of antipyretics and/or analgesic medications.

  13. Participant has a history of substance or alcohol abuse within the past 2 years.

  14. Female participants who are pregnant (that is, a positive or indeterminate pregnancy test).

  15. Female participants who are breastfeeding.

  16. Female participants of childbearing potential who are sexually active and who have not used any of the acceptable contraceptive methods for at least 2 months prior to Day 1 (M0).

  17. Female participants of childbearing potential who are sexually active and who refuse to use an acceptable contraceptive method up to 6 weeks post final vaccination on Day 90 (M3). In addition, they must also be advised not to donate ova during this period.

  18. Participant has received any of the following:

    1. A licensed vaccine within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to TDV or placebo administration on Day 1 (M0). This includes co-administration with routine vaccines.
    2. A coronavirus vaccine within 14 days prior to TDV or placebo administration.
    3. A vaccine authorized for emergency use within 28 days prior to TDV or placebo administration.

  19. Participant is scheduled to receive any other vaccine within 28 days after TDV or placebo administration.

  20. Participant is participating in any clinical trial with another investigational product 30 days prior to Day 1 (M0) or intending to participate in another clinical trial at any time during the conduct of this trial.

  21. Participant has taken part in any clinical trial of a dengue or other flavivirus (example, West Nile virus) candidate vaccine, except if it is known that the participant received placebo in those trials.

  22. Participant or their first-degree relatives are involved in the trial conduct.

  23. Participant identified as an employee of the investigator or trial center, with direct involvement in the proposed trial or other trials under the direction of that investigator or trial center.

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
实验性的：Cohort 1: Tetravalent Dengue Vaccine (TDV) 0.5 mL

Participants with the age group greater than (>) 60 to 79 years will receive TDV, 0.5 mL subcutaneous (SC) injections, on Day 1 and Day 90.
生物：TDV

TDV SC injection.

其他名称：
  • TAK-003
安慰剂比较：Cohort 1: Placebo

Participants with the age group >60 to 79 years will receive placebo (normal saline), 0.5 mL SC injections, on Day 1 and Day 90.
其他：Placebo

Placebo SC injection.
实验性的：Cohort 2: TDV 0.5 mL

Participants with the age group 45 to 60 years will receive TDV, 0.5 mL SC injection, on Day 1 and Day 90.
生物：TDV

TDV SC injection.

其他名称：
  • TAK-003

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
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1
大体时间：Within 7 days post-vaccination at Day 1

An AE is defined as any untoward medical occurrence in a clinical investigation participant administered an investigational medical product (IMP); it does not necessarily have to have a causal relationship with IMP administration. Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Within 7 days post-vaccination at Day 1
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 90
大体时间：Within 7 days post-vaccination at Day 90

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Within 7 days post-vaccination at Day 90
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1
大体时间：Within 14 days post-vaccination at Day 1

Solicited systemic AEs include fever (body temperature greater than or equal to [>=] 38 degree Celsius [C], asthenia, malaise, headache, and myalgia.
Within 14 days post-vaccination at Day 1
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 90
大体时间：Within 14 days post-vaccination at Day 90

Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia.
Within 14 days post-vaccination at Day 90
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 1
大体时间：Within 7 days post-vaccination at Day 1

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Within 7 days post-vaccination at Day 1
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 Days Post Vaccination at Day 90
大体时间：Within 7 days post-vaccination at Day 90

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Within 7 days post-vaccination at Day 90
Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 1
大体时间：Within 14 days post-vaccination at Day 1

Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Within 14 days post-vaccination at Day 1
Percentage of Participants with Solicited Systemic AEs by Severity Within 14 Days Post Vaccination at Day 90
大体时间：Within 14 days post-vaccination at Day 90

Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Within 14 days post-vaccination at Day 90
Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 1
大体时间：Within 28 days post-vaccination at Day 1

An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration).
Within 28 days post-vaccination at Day 1
Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination at Day 90
大体时间：Within 28 days post-vaccination at Day 90

An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day of IMP administration).
Within 28 days post-vaccination at Day 90
Percentage of Participants with a Serious Adverse Event (SAE)
大体时间：From first vaccination on Day 1 through the end of trial (up to Day 270)

An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event.
From first vaccination on Day 1 through the end of trial (up to Day 270)
Geometric Mean Titers (GMTs) of Neutralizing Antibodies by Microneutralization Test (MNT) for Each of the 4 Dengue Virus Serotypes at Day 120
大体时间：At Day 120

GMTs of neutralizing antibodies will be measured by microneutralization test 50% [MNT50] for each of the 4 Dengue Serotypes in all participants. The 4 dengue virus serotypes are dengue virus (DENV)-1, DENV-2, DENV-3 and DENV-4.
At Day 120

次要结果测量

结果测量
措施说明
大体时间
Number of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
大体时间：Within 7 days post-vaccination at Day 1 and Day 90

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration.
Within 7 days post-vaccination at Day 1 and Day 90
Number of Participants with Solicited Systemic AEs Within 14 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
大体时间：Within 14 days post-vaccination at Day 1 and Day 90

Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia.
Within 14 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Solicited Local (Injection Site) AEs by Severity Within 7 days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
大体时间：Within 7 days post-vaccination at Day 1 and Day 90

Solicited local AEs are injection site pain/tenderness, erythema, and swelling at the vaccination site. All solicited AEs at the injection site will be considered related to the study vaccine administration. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Within 7 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Solicited Systemic AEs by Severity (With Comorbidities)
大体时间：Within 14 days post-vaccination at Day 1 and Day 90

Solicited systemic AEs include fever (body temperature >= 38 degree (C), asthenia, malaise, headache, and myalgia. The AEs will be graded by investigator as Grade 0: none, Grade 1: mild, Grade 2: moderate and Grade 3: severe.
Within 14 days post-vaccination at Day 1 and Day 90
Percentage of Participants with Any Unsolicited AEs Within 28 Days Post Vaccination (With Comorbidities)
大体时间：Within 28 days post-vaccination at Day 1 and Day 90

An unsolicited AE is any AE reported by the participant that is not specified as a solicited AE or is specified as a solicited AE but starts outside the period for reporting a solicited AE (that is, 7 days and 14 days in total including the day IMP administration).
Within 28 days post-vaccination at Day 1 and Day 90
Percentage of Participants with a SAE (With Comorbidities)
大体时间：From first vaccination on Day 1 through the end of trial (up to Day 270)

An SAE is defined as any untoward medical occurrence that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, leads to a congenital anomaly/birth defect in the offspring of a participant, is an important medical event.
From first vaccination on Day 1 through the end of trial (up to Day 270)
Geometric Mean Titers by MNT for Each of the 4 Dengue Virus Serotypes
大体时间：Day 1, Day 30, Day 90 and Day 270

GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 dengue serotypes in all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Day 1, Day 30, Day 90 and Day 270
Geometric Mean Titers by MNT for Each of the 4 Dengue Virus Serotypes (With Comorbidities)
大体时间：Day 1, Day 30, Day 90, Day 120 and Day 270

GMTs of neutralizing antibodies will be measured by MNT50 for each of the 4 dengue serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Each of the 4 Dengue Virus Serotypes
大体时间：Day 1, Day 30, Day 90, Day 120 and Day 270

Seropositivity rate is defined as the percentage of participants with MNT titer >=10 against each of the four dengue virus serotypes in all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Each of the 4 Dengue Virus Serotypes (With Comorbidities)
大体时间：Day 1, Day 30, Day 90, Day 120 and Day 270

Seropositivity rate is defined as the percentage of participants with MNT titer >=10 against each of the four dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Multiple (2, 3, or 4) Dengue Virus Serotypes
大体时间：Day 1, Day 30, Day 90, Day 120 and Day 270

Seropositivity rate is defined as the percentage of participants with MNT titer >=10 against multiple (2, 3, or 4) dengue virus serotypes in all participants. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Day 1, Day 30, Day 90, Day 120 and Day 270
Seropositivity Rate for Multiple (2, 3, or 4) Dengue Virus Serotypes (With Comorbidities)
大体时间：Day 1, Day 30, Day 90, Day 120 and Day 270

Seropositivity rate is defined as the percentage of participants with MNT titer >=10 against multiple (2, 3, or 4) dengue virus serotypes. The 4 dengue virus serotypes are DENV-1, DENV-2, DENV-3 and DENV-4.
Day 1, Day 30, Day 90, Day 120 and Day 270

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。

赞助

Takeda

调查人员

  • 研究主任：Study Director、Takeda

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。

有用的网址

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)

2026年1月20日

初级完成 (估计的)

2027年4月14日

研究完成 (估计的)

2027年4月14日

研究注册日期

首次提交

2024年8月29日

首先提交符合 QC 标准的

2024年8月29日

首次发布 (实际的)

2024年8月30日

研究记录更新

最后更新发布 (实际的)

2026年9月22日

上次提交的符合 QC 标准的更新

2026年9月21日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • DEN-321

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

Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

IPD 共享访问标准

IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

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.

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