A Study of Dengue Vaccine in Healthy Children, Teenagers and Adults in India
3상
완료
NCT06060067
| 대상 질환 | Healthy Volunteers |
|---|
| 임상 단계 | 3상 |
|---|
| 스폰서 | Takeda |
|---|
| 상태 | 완료 |
|---|
| 참여자 수 | 480 명 |
|---|
| 중재(약물) | TDV |
|---|
| 시작일 | 2024년 3월 29일 |
|---|
| 완료일 | 2025년 5월 5일 |
|---|
| 결과 공개일 | 2026년 5월 29일 |
|---|
요약
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 |
|---|
BENITIONS에서 보기
ClinicalTrials.gov 원문 보기
전체 임상
이 페이지는 ClinicalTrials.gov의 공개 데이터를 정리한 것입니다. 의학적 조언이 아니며 투자 권유나 자문도 아닙니다. 반드시 전문의와 상담하세요.