jRCTs011180010招募中不适用
Safety and efficacy of tick-borne encephalitis vaccine (TBEV2018)
未提供0 个研究点目标入组 300 人开始时间: 2017年4月24日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 1age old over 至 No limit（—）
- 性别
- All
入选标准
- •Age above 1 at study consent
- •Anyone who has risk of tick bite
- •Subjects who understand and agree with participation of their free will
排除标准
- •Patients suspected with acute illness such as fever
- •Patients currently under treatment for any acute illness or patients who have not recovered from acute illness for more than 1 week
- •Severe immunodeficiency
- •History of severe adverse reaction or allergy after tick-borne encephalitis vaccine
- •Hypersensitivity to formaldehyde, neomycin, gentamycin, protamine sulfate)
- •Severe hypersensitivity to egg and chick proteins (anaphylactic reaction after oral ingestion of egg protein)
- •Severe hypersensitivity to latex (anaphylactic reaction to latex)
- •Pregnancy or breastfeeding
- •Participants who deemed inappropriate by principal investigator
- •For first time vaccination: tick bite within 4 weeks
结局指标
主要结局
-
Frequency of local and systemic adverse reaction of 1st tick-borne encephalitis vaccination
次要结局
- Seroconversion rate of tick-borne encephalitis antibody