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成人（45～60歳および60歳以上～79歳）を対象としたデング熱四価ワクチン（TDV）の研究

2026年9月21日 更新者：Takeda

第 3 相、無作為化、二重盲検、プラセボ対照 (高齢者、60 ～ 79 歳以上) および非盲検 (成人、45 ～ 60 歳)、デング熱 4 価ワクチンの安全性と免疫原性を調査するための多施設共同試験デング熱流行地域において、併存疾患の有無にかかわらず成人および高齢者に皮下投与されるワクチン（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.

調査の概要

状態

積極的、募集していない

条件

介入・治療

研究の種類

介入

入学 (実際)

800

段階

  • フェーズ 3

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

  • アルゼンチン
      • Buenos Aires、アルゼンチン、C1427CEA
        • Fundacion Huesped - PPDS
  • シンガポール
      • Singapore、シンガポール、169608
        • Singapore General Hospital (SGH)
      • Singapore、シンガポール、308433
        • Tan Tock Seng Hospital
  • タイ
    • Bangkok
      • Ratchathewi、Bangkok、タイ、10400
        • Ramathibodi Hospital
    • Krung Thep Maha Nakhon-Bangkok
      • Ratchathewi、Krung Thep Maha Nakhon-Bangkok、タイ、10400
        • Hospital for Tropical Diseases
  • ブラジル
    • Estado de Bahia
      • Salvador、Estado de Bahia、ブラジル、40444-130
        • Associacao Obras Sociais Irma Dulce Hospital Santo Antonio
    • São Paulo
      • São José do Rio Preto、São Paulo、ブラジル、15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

45年～79年 (大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：トリプル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
生物学的：TDV

TDV SC injection.

他の名前：
  • TAK-003
プラセボコンパレーター：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.
他の：Placebo

Placebo SC injection.
実験的：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.
生物学的：TDV

TDV SC injection.

他の名前：
  • TAK-003

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants with Solicited Local (Injection Site) Adverse Events (AEs) Within 7 Days Post Vaccination at Day 1
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Participants with Solicited Local (Injection Site) AEs Within 7 Days Post Vaccination at Day 1 and Day 90 (With Comorbidities)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Takeda

捜査官

  • スタディディレクター：Study Director、Takeda

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年1月20日

一次修了 (推定)

2027年4月14日

研究の完了 (推定)

2027年4月14日

試験登録日

最初に提出

2024年8月29日

QC基準を満たした最初の提出物

2024年8月29日

最初の投稿 (実際)

2024年8月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月22日

QC基準を満たした最後の更新が送信されました

2026年9月21日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • DEN-321

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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