NCT00595309已完成3 期
Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51 on Long Term Immunogenicity. An Uncontrolled, Open-label Phase 3 Study.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 198
- 试验地点
- 3
- 主要终点
- Seroconversion Rate
研究概览
简要总结
The objective is to assess the effect of a booster vaccination on immunogenicity of IC51 in terms of seroconversion rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults who completed the primary immunization in study IC51 309
- •Male and female healthy subjects aged at least 18 years with written informed consent and either no childbearing potential or negative pregnancy test
排除标准
- •History of immunodeficiency or immunosuppressive therapy, known Human Immunodeficiency Virus (HIV), or drug addiction including alcohol dependence
结局指标
主要结局
Seroconversion Rate
时间窗: at Month 12 after booster
次要结局
- Geometric Mean Titer(D28, Month 6 and Month 12 after booster)
- Safety and Adverse Events(up to Month 12 after booster)
- Seroconversion(at D28 and Month 6 after booster)
研究者
研究点 (3)
Loading locations...
相似试验
Unknown
4 期
Antibody Response of a Boosted Japanese Encephalitis Chimeric Virus Vaccine (JE-CV) in ChildrenJapanese EncephalitisNCT01954810Khon Kaen University88
已完成
3 期
Concomitant Vaccination With the Japanese Encephalitis Vaccine IC51 and HARVIX® 1440Japanese EncephalitisNCT00596271Valneva Austria GmbH192
已完成
3 期
Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51Japanese EncephalitisNCT00595270Valneva Austria GmbH349
已完成
3 期
Immunogenicity and Safety of the Japanese Encephalitis Vaccine IC51 (IXIARO®, JESPECT®) in a Pediatric Population in Non-endemic CountriesEncephalitisNCT01047839Valneva Austria GmbH100
已完成
3 期
Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate VaccineMeningococcal InfectionsMeningococcal MeningitisMeningitisNCT02752906Sanofi Pasteur, a Sanofi Company810