A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
第3相
完了
NCT06060067
| 対象疾患 | Healthy Volunteers |
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| 相 | 第3相 |
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| スポンサー | Takeda |
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| ステータス | 完了 |
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| 参加者数 | 480 名 |
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| 介入（薬剤） | TDV |
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| 開始日 | 2024年3月29日 |
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| 完了日 | 2025年5月5日 |
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| 結果公開日 | 2026年5月29日 |
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概要
The main aims of the study are to learn about side effects and a participant's immune response to Takeda's Dengue Vaccine when given twice within 3 months. Participants will receive 2 doses of their randomized treatment (vaccine or placebo). Children, teenagers and adults will receive one dose of either the vaccine or placebo on Day 1 and the second dose of either the vaccine or placebo 3 months later. Up to 4 blood samples will be taken throughout the study. During the study, participants will visit their study clinic 6 times.
Number of Participants With Solicited Local (Injection Site) Adverse Events (AEs) by Severity Within 7 Days Post-vaccination at Day 1 for Age Group Less Than 6 Years
Within 7 days post-vaccination at Day 1 · Participants
| Cohort 2: ≥4 to <6 Years Age Group: TDV | 42 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 10 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: TDV | 4 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 4 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: TDV | 0 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 0 Participants |
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Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 1 for Age Group 6 Years and Over
Within 7 days post-vaccination at Day 1 · Participants
| Cohort 1: ≥18 to ≤60 Years Age Group: TDV | 152 Participants |
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| Cohort 1: ≥18 to ≤60 Years Age Group: Placebo | 53 Participants |
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| Cohort 2: ≥6 to <18 Years Age Group: TDV | 119 Participants |
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| Cohort 2: ≥6 to <18 Years Age Group: Placebo | 42 Participants |
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| Cohort 1: ≥18 to ≤60 Years Age Group: TDV | 25 Participants |
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| Cohort 1: ≥18 to ≤60 Years Age Group: Placebo | 7 Participants |
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Number of Participants With Solicited Local (Injection Site) AEs by Severity Within 7 Days Post-vaccination at Day 90 for Age Group Less Than 6 Years
Within 7 days post-vaccination at Day 90 · Participants
| Cohort 2: ≥4 to <6 Years Age Group: TDV | 44 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 14 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: TDV | 2 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 0 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: TDV | 0 Participants |
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| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 0 Participants |
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BENITIONS で見る
ClinicalTrials.gov の原文を見る
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