A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
3期
已完成
NCT06060067
| 适应症 | Healthy Volunteers |
|---|
| 分期 | 3期 |
|---|
| 申办方 | Takeda |
|---|
| 状态 | 已完成 |
|---|
| 受试者人数 | 480 人 |
|---|
| 干预（药物） | TDV |
|---|
| 开始日期 | 2024年3月29日 |
|---|
| 完成日期 | 2025年5月5日 |
|---|
| 结果公布日 | 2026年5月29日 |
|---|
摘要
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 |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 10 Participants |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: TDV | 4 Participants |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 4 Participants |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: TDV | 0 Participants |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 0 Participants |
|---|
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 |
|---|
| Cohort 1: ≥18 to ≤60 Years Age Group: Placebo | 53 Participants |
|---|
| Cohort 2: ≥6 to <18 Years Age Group: TDV | 119 Participants |
|---|
| Cohort 2: ≥6 to <18 Years Age Group: Placebo | 42 Participants |
|---|
| Cohort 1: ≥18 to ≤60 Years Age Group: TDV | 25 Participants |
|---|
| Cohort 1: ≥18 to ≤60 Years Age Group: Placebo | 7 Participants |
|---|
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 |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 14 Participants |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: TDV | 2 Participants |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 0 Participants |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: TDV | 0 Participants |
|---|
| Cohort 2: ≥4 to <6 Years Age Group: Placebo | 0 Participants |
|---|
在 BENITIONS 中查看
查看 ClinicalTrials.gov 原文
全部试验
本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。