NCT00387634已完成4 期
A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization
Novartis Vaccines1 个研究点 分布在 1 个国家目标入组 323 人开始时间: 2006年9月最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 323
- 试验地点
- 1
- 主要终点
- immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA
研究概览
简要总结
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 68 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects who have completed study V48P7
排除标准
- •acute illness at day of immunization
- •general decrease in resistance
- •progressive neurological disorders
- •history of febrile or afebrile convulsions
- •major congenital defects
- •serious chronic illness
- •hypersensitivity to study vaccine
- •treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates
结局指标
主要结局
immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA
时间窗: On day 21, year 1, year 2, year 3, year 4, year 5
次要结局
- safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting(Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Study of the Safety, Tolerability and Immune Response of TBE Vaccines Administered to Healthy ChildrenEncephalitis, Tick-BorneNCT00311441Novartis300
已完成
4 期
Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five YearsEncephalitis, Tick-BorneNCT00452621Novartis235
已完成
1 期
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against COVID-19COVID-19 VaccineNCT05216601Medigen Vaccine Biologics Corp.107
已完成
3 期
Study to Evaluate the Immunogenicity, Safety, and Tolerability of a Tick-Borne Encephalitis (TBE) Vaccine in Healthy Japanese Participants 1 Year of Age and OlderTick-Borne EncephalitisJPRN-jRCT2031200302Kawai Norisuke165
进行中（未招募）
4 期
The Immunogenicity and Safety of the Booster Doses of a Live-attenuated Mumps Vaccine in Junior High School StudentsInfluenzaMumpsNCT06208683Sinovac Biotech Co., Ltd400