NCT01981967已完成4 期
Post-licensure, Phase IV, Safety Study of IMOJEV® in Thailand
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10,000
- 试验地点
- 8
- 主要终点
- Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
研究概览
简要总结
The aim of this study is to further characterize the safety profile of IMOJEV®.
Primary Objective:
- To describe serious adverse events (SAEs, including adverse events of special interest [AESIs]) up to 60 days after administration of one dose of IMOJEV®.
Secondary Objective:
- To describe Grade 3 (severe) systemic Adverse Events (AEs) up to 30 minutes after administration of one dose of IMOJEV®.
详细描述
Participants aged 1 year to less than 5 years will be randomized to receive one injection of IMOJEV® either as a primary vaccination or as a booster. Safety data will be collected for 60 days after IMOJEV® vaccination. The duration of each subject's participation in the trial will be 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children requiring vaccination against Japanese encephalitis
- •Children aged 9 months to less than 5 years on the day of inclusion
- •In good general health at the time of inclusion
- •Informed consent form has been signed and dated by the parent(s)/legal guardian(s)
- •Subject and parent(s)/legal guardian(s) are able to attend the scheduled visit and any additional visits that may need to be done in case of an SAE (including AESI), and are able to comply with all trial procedures
- •The subject's parent(s)/legal guardian(s) have a telephone number at which they can be contacted throughout the study
排除标准
- •Participation in another clinical trial investigating a vaccine, drug, medical device, or medical procedure in the 4 weeks preceding the vaccination
- •Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine in the 4 weeks following the study vaccination
- •Planned participation in another clinical trial during the present trial period
- •Children previously vaccinated with the live attenuated Japanese encephalitis vaccine CD-JEVAX® (SA14-14-2 LAV)
- •Contraindications to vaccination according to the IMOJEV® Summary of Product Characteristics (SmPC)
- •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
- •Children who received IMOJEV® as primary vaccination in this study.
结局指标
主要结局
Number of Participants Experiencing a Grade 3 Immediate Systemic Adverse Events and Serious Adverse Events Following Any Vaccination With IMOJEV®
时间窗: 30 minutes post-vaccination up to Day 60 post-vaccination
Number of Participants Experiencing Serious Adverse Events By Age Following Any Vaccination With IMOJEV®
时间窗: Day O up to Day 60 post-vaccination
次要结局
- Number of Participants Experiencing Adverse Events of Special Interest Within 60 Days Following Vaccination With IMOJEV®(Day O up to Day 60 post-vaccination)
研究者
研究点 (8)
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