CTRI/2024/01/061776已完成1/2 期
A Seamless Phase 1/2, double blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of Dengusiil in Indian adults and children of more than 2 years of age
Serum Institute of India Private Limited (SIIPL)4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年2月1日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- 1. The occurrence and severity of solicited local and systemic reactions
研究概览
简要总结
This is a seamless Phase 1/2, multi-center, double-blind, randomized, placebo-controlled clinical trial to be performed initially in healthy adults of 18 to 60 years of age (n=45) and then followed in children of >=2 to <18 years of age (n=75). The study will have two groups: Dengusiil and Placebo given to participants randomized in 2:1 ratio. Each participant will receive a single subcutaneous (SC) injection of either Dengusiil or placebo and will be followed up for 180 days after the vaccination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy adults aged 18-60 years of age.
- •adult cohort
- •Healthy children aged more than 2 to less than 18 years of age for pediatric cohort
- •Participants who give written informed consent and or assent for children of more than 12 to less than 18 years of age.
排除标准
- •Previous dengue vaccination.
- •Presence of acute infection in the preceding 14 days or presence of a temperature more than 38 degree celcious or acute symptoms of infection greater than of mild severity on the day of vaccination
- •Participation or planned participation in a study involving the administration of an investigational product within the past one month or during this study period.
- •A family history of congenital or hereditary immunodeficiency.
- •Women who are pregnant, breast-feeding, or considering becoming pregnant.
- •All participants of childbearing potential must agree to use medically acceptable forms of contraception from screening until 60 days post vaccination.
结局指标
主要结局
1. The occurrence and severity of solicited local and systemic reactions
时间窗: 21 days following vaccination
2. The occurrence, severity, and relatedness to vaccination of unsolicited adverse events
时间窗: 21 days following vaccination
次要结局
- Geometric mean titers (GMTs)(Day 1, 85 and 181)
- Neutralizing antibodies(Day 85 and Day 181)
研究者
研究点 (4)
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